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THE MINISTRY OF
HEALTH OF VIETNAM
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THE SOCIALIST
REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No. 7115/QD-BYT
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Hanoi, December
01, 2016
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DECISION
PROMULGATING
PROCEDURES FOR INSPECTION OF MEDICAL DEVICES
THE MINISTER OF HEALTH OF VIETNAM
Pursuant to the Law on Inspection No.
56/2010/QH12 dated November 15, 2010;
Pursuant to the Government’s Decree No.
36/2016/ND-CP dated May 15, 2016 prescribing medical device management;
Pursuant to the Government’s Decree No.
86/2011/ND-CP dated September 22, 2011 elaborating and providing guidelines for
implementation of the Law on Inspection;
Pursuant to the Government’s Decree No.
07/2012/ND-CP dated February 09, 2012 stipulating regulatory authorities
assigned to conduct specialized inspections and specialized inspection
contents;
Pursuant to the Government’s Decree No. 87/2011/ND-CP
dated September 27, 2011 elaborating and providing guidelines for
implementation of the Law on Medical Examination and Treatment;
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Pursuant to the Government’s Decree No.
122/2014/ND-CP December 25, 2014 prescribing organization and operation of
health inspectorates;
Pursuant to the Circular No. 05/2014/TT-TTCP
dated October 16, 2014 of the Government Inspectorate promulgating regulations
on organization, operation, work relationship and procedures for conducting an
inspection;
Pursuant to the Circular No. 07/2002/TT-BYT
dated May 30, 2002 of the Ministry of Health of Vietnam providing guidelines
for application for marketing authorization for medical devices;
Pursuant to the Circular No. 30/2015/TT-BYT
dated October 12, 2015 of the Ministry of Health of Vietnam providing
guidelines for import of medical devices;
At the request of the Chief Inspector of the
Ministry of Health of Vietnam,
HEREIN DECIDES:
Article 1. Procedures for inspection of
medical devices are issued together with this Decision.
Article 2. Inspection of manufacturing,
trading and management of use of medical devices shall comply with provisions
of section 8 part 2 of the Procedures.
Article 3. This Decision comes into force
from the date on which it is signed.
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PP. MINISTER
DEPUTY MINISTER
Nguyen Viet Tien
PROCEDURES
FOR INSPECTION OF
MEDICAL DEVICES
(Enclosed with Decision No. 7115/QD-BYT dated December 01, 2016 of the
Minister of Health of Vietnam)
Part 1.
GENERAL PROVISIONS
1. Scope and
regulated entities
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These Procedures apply to planned inspections, ad
hoc inspections, and inspections which are conducted to serve the settlement of
complaints and denunciations, and performance of anti-corruption tasks.
These Procedures apply to inspectors, officials in
charge of health inspection tasks, and members of inspection teams in the field
of medical devices.
2. Objectives and
requirements
2.1. Objectives
Inspections are aimed at finding loopholes in
management mechanisms, policies and laws and requesting competent authorities
to adopt appropriate measures for preventing, detecting, handling and remedying
such loopholes or to take actions against violations of law; assisting
regulatory authorities, organizations and individuals in complying with law;
promoting positive factors; contributing to improvement of efficiency and
effectiveness of state management; protecting the State interests as well as
legitimate rights and benefits of regulatory authorities, organizations and
individuals.
2.2. Requirements
Inspections must comply with regulations of law and
be conducted in a manner that ensures accuracy, honesty, transparency,
democracy and timeliness, and causes no obstruction to normal operation of the
inspected entities.
3. Legislative
documents on medical devices
- The Law on Medical Examination and Treatment No.
40/2009/QH12 dated November 23, 2009;
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- The Government’s Decree No. 36/2016/ND-CP dated
May 15, 2016 on management of medical devices;
- The Government’s Decree No. 87/2011/ND-CP dated
September 27, 2011 elaborating and providing guidelines for implementation of
the Law on Medical Examination and Treatment;
- The Government’s
Decree No. 176/2013/ND-CP dated November 14, 2013 prescribing penalties for administrative violations in
health sector;
- The Government’s Decree No. 187/2013/ND-CP
dated November 20, 2013 elaborating the Law on Commerce regarding international
goods trading and goods purchase, sale, processing and transit agency
activities with foreign countries.
- The Circular No. 30/2015/TT-BYT dated October 12,
2015 of the Ministry of Health of Vietnam providing guidelines for import of
medical devices;
- The Circular No. 07/2002/TT-BYT dated May 30,
2002 of the Ministry of Health of Vietnam providing guidelines for application
for marketing authorization for medical devices;
- The Circular No. 41/2011/TT-BYT dated November
14, 2011 of the Minister of Health of Vietnam providing guidelines for issuance
of practicing certificates to medical practitioners and issuance of operating
licenses to health facilities; the Circular No. 41/2015/TT-BYT dated November
16, 2015 of the Minister of Health of Vietnam providing amendments to the
Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Minister of Health
of Vietnam;
- The Circular No. 09/2015/TT-BYT dated May 25,
2015 of the Ministry of Health of Vietnam prescribing approval for contents of
advertisements for special products, commodities and services under management
of the Ministry of Health of Vietnam;
- The Decision No. 1895/1997/QD-BYT dated September
19, 1997 of the Ministry of Health of Vietnam promulgating regulations on
hospitals;
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- Other relevant legislative documents.
Part 2.
PROCEDURES FOR CONDUCTING AN INSPECTION OF MEDICAL
DEVICES
STEP 1. PREPARATION FOR INSPECTION
1. Collection of information and documents
before making inspection decisions
1.1. Before making inspection decisions, heads of
regulatory authorities or state inspection authorities shall, where deemed
necessary, direct the collection of information and documents to serve their
making of inspection decisions.
Appointment or designation of officials or groups
of officials to collect information and documents (hereinafter referred to as “information
collecting official”) must be made in writing. The collection of information
must be completed within 15 working days.
1.2. For the purpose of collecting information from
regulatory authorities, organizations and individuals, an information collecting
official must present:
a) a written appointment of official to take charge
of information collection which is made by the head of the relevant inspection
authority and must indicate description of tasks, performance time, and
information to be collected; and
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1.3. The information collecting official is
prohibited from harassing or disturbing regulatory authorities, organizations
and individuals that are requested to provide information, or requesting them
to provide information pieces other than those defined in his/her written
appointment.
1.4. The information collecting official shall
study, analyze, assess and consolidate collected information and documents; and
within 05 working days upon completion of information collection, make and
submit a written report on information collection results to his/her head. A
report on information collection results shall, inter alia, include:
a) General description of functions, tasks, powers,
and regulations of laws governing organization and operation of the entity
subject to the inspection (hereinafter referred to as “subject entity”);
b) Current state and performance of the subject
entity; inspection, audit and investigation results relating to the planned
contents of inspection given by competent authorities (if any) and other
relevant information.
c) Determination of issues that require more
attention and signs of violation, and recommended contents and methods of
inspection.
1.5. Information collection methods
a) Collect information and documents from the
subject entity; from regulatory authorities in charge of managing sectors and
fields relating to the contents of inspection;
b) Study and consolidate information collected from
press agencies, feedbacks, complaints and denunciations relating to the
contents of inspection;
c) Directly contact related persons, where
necessary.
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2.1. Grounds for making an inspection decision
Pursuant to provisions of Article 38 of the Law on
Inspection No. 56/2010/QH12 dated November 15, 2010 (hereinafter referred to as
"Inspection Law”), an inspection decision must be made on one of the
following grounds:
- Under an approved annual inspection plan.
- At the request of the head of a regulatory authority;
- Upon detection of any signs of violation against
laws; or
- For the purpose of settlement of a complaint or
denunciation, or performance of anti-corruption tasks.
2.2. Contents of an inspection decision
In consideration of available grounds and the
report on information collection results (if any), the head of the relevant
regulatory authority or state inspection authority shall make an inspection
decision and direct the inspection team to develop a detailed inspection plan.
The inspection decision shall be made according to provisions of Article 52 of
the Inspection Law, and shall include the following contents as a minimum:
- Legal grounds for conducting the inspection;
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- Duration of inspection;
- Head, inspectors and other members of the
inspection team.
The inspection decision shall be made using Form
No. 04-TTr enclosed with the Circular No. 05/2014/TT-TTCP dated October 16,
2014 of the Government Inspectorate (hereinafter referred to as “Circular No.
05/2014/TT-TTCP”).
3. Formulation and approval of an inspection
plan
3.1. The head of the inspection team shall take
charge of organizing the formulation of an inspection plan and submitting it to
the person who made an inspection decision (hereinafter referred to as
"inspection decision maker") for approval.
3.2. Formulation and approval of an inspection plan
must comply with provisions of Article 18 of the Government’s Decree No. 07/2012/ND-CP dated February 09, 2012
(hereinafter referred to as “Decree No. 07/2012/ND-CP”).
Contents of an inspection plan: objectives, requirements, scope, contents,
inspected entity, inspection period, and duration of inspection; methods for
conducting the inspection, inspection schedule, information provision,
reporting, employed facilities and equipment, funding and other material
conditions necessary for the inspection team; organization of implementation of
the inspection plan.
3.3. The time limit for formulation and approval of
an inspection plan shall be decided by the inspection decision maker but shall
not exceed 05 working days from the issue date of the inspection decision. In
case of an ad hoc inspection, this time limit shall not exceed 03 working days.
3.4. The inspection plan shall be formulated using
Form No. 05-TTr enclosed with the Circular No. 05/2014/TT-TTCP and considered
as an internal document of the inspection team.
4. Dissemination of inspection plan
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4.2. Sub-team leaders and members of the inspection
team must develop their own plans to perform assigned tasks and report them to
the head of the inspection team.
4.3. Where necessary, the head of the inspection
team shall organize professional training for members of the inspection team.
5. List of issues to be reported by the
inspected entity
5.1. Based on the inspection contents and the
inspection plan, the head of the inspection team shall play the leading role
and cooperate with other members of the inspection team in preparing a list of
issues to be reported by the inspected entity.
5.2. The head of the inspection team shall give a
reporting request (accompanied with the list of issues to be reported) to the
inspected entity at least 05 working days before the date of announcement of
the inspection decision; such request must clearly state the reporting method
and deadline for report submission, except ad hoc inspections.
Issues to be reported by the inspected entity must
be conformable with the inspection contents specified in the inspection
decision.
6. Notification of announcement of inspection
decision
Notification of announcement of inspection decision
shall comply with provisions of Article 21 of the Decree
No. 07/2012/ND-CP and only apply to planned inspections. To be specific:
Before the inspection decision is announced, the
head of the inspection team shall notify the inspected entity of such
announcement of inspection decision. Where necessary, the inspection decision
maker may be requested to give a written notice to the inspected entity. Such
notice must clearly state the time and place of announcement, and required
participants.
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7. Announcement of inspection decision
7.1. Within 15 days from the day on which the
inspection decision is signed, the head of the inspection team shall organize
the announcement of the inspection decision to the inspected entity.
7.2. Participants in the announcement session
include the inspected entity and other participants decided by the inspection decision
maker on the basis of the inspection team’s report.
7.3. The head of the inspection team shall preside
over the announcement session; ratify the agenda; read the full text of the
inspection decision; declare the objectives, requirements, contents and
duration of the inspection; tasks and powers of the inspection team; rights and
responsibilities of the inspected entity; working plan of the inspection team;
work relationship between the inspection team and the inspected entity; other
contents concerning operation of the inspection team.
7.4. Head of the authority or organization or
individual that is subject to the inspection shall present their report on the
inspection contents (according to the received list of issues to be reported).
7.5. Other participants in the announcement session
shall express their opinions about the inspection contents (if any).
7.6. A written record of the announcement of
inspection decision must be made, and bear signatures of the head of the
inspection team and the head of authority or organization or individual that is
subject to the inspection.
The record of the announcement of inspection
decision is made using Form No. 06-TTr enclosed with the Circular No.
05/2014/TT-TTCP.
8. Contents of medical device inspection
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a) Legal documents and organizational structure:
- Legal documents of the inspected entity
- Documentary evidences of its eligibility to carry
out classification of medical devices, including: the receipt note of
declaration of eligibility to carry out classification of medical devices which
is given by the Ministry of Health of Vietnam
- Profiles of personnel in charge of classification
tasks: professional qualifications, experience of working directly with medical
device techniques at medical device facilities, and certificates of completion
of training courses in medical device classification issued by qualified
training institutions.
b) Documents on declaration of eligibility to carry
out classification of medical devices
- The declaration form of eligibility to carry out
classification of medical devices
- The list of personnel in charge of medical device
classification, and training certificates.
- Documents on classified medical devices
d) Compliance with regulations on classification of
medical devices: Compliance with rules for classification of medical devices
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8.2. Contents of an inspection of medical device
manufacturer
a) Legal documents and organizational structure:
- Legal documents of the inspected entity;
- Declaration of eligibility for manufacture of
medical devices of the inspected entity; the receipt note of the declaration of
eligibility for manufacture of medical devices which is given by a competent
authority.
- Certificate of quality control system;
- Qualifications/degrees of the chief technician;
- Documents proving that it has sufficient and
qualified personnel for manufacturing the registered type of medical devices;
- Documents on organizational structure; employment contracts, description of each job
position, and documents stating responsibilities and work relationship of each
employee.
b) Material facilities and equipment: Satisfaction
of requirements regarding manufacturing workshop and warehouse, occupational
safety, fire and explosion prevention and control, waste and wastewater
treatment systems.
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- Documents on application for marketing
authorization: application form; declaration of applied standards; results of
testing conducted at health facilities; results of testing for physical and
chemical properties; safety inspection results (for medical devices subject to
mandatory testing and inspection); Technical file and instructions for use;
label; marketing authorization; pre-shipment inspection results;
receipts/invoices of purchase of input materials.
d) Compliance with regulations on manufacture of
medical devices:
- Matching between the scope and types of medical
devices to be manufactured by the inspected entity and the professional scope
and contents of the certificate of eligibility for manufacture of medical
devices issued by the Ministry of Health of Vietnam;
- Documents on manufacturing of medical devices;
medical device manufacturing procedures; equipment and devices used for
manufacturing and storing medical devices; quality inspection in comparison
with the declaration of quality standards; logbooks of product quality
inspection results; product label compared to that included in the application;
inspection reports given by competent authorities;
e) Advertisement for medical devices:
- Written approval of advertisement for medical
device issued by a competent authority and contents of advertisement for
domestically manufactured products in comparison with contents of advertisement
approved by competent health authorities.
(Further details are available in Appendix No. 2
enclosed herewith)
8.3. Contents of an inspection of entity whose name
is specified in the declaration of applied standards or marketing authorization
for medical devices
a) Legal documents and organizational structure:
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- Documentary evidences of the inspected entity’s
eligibility to declare applied standards or apply for marketing authorization
for medical devices: contract signed with the entity that is capable of
providing warranty for medical devices
b) Documents on declaration of applied standards
and application for marketing authorization for medical devices: based on
medical device classification results.
- Declaration form of applied standards for class-A
medical devices and number of marketing authorization for class-B, class-C or
class-D medical devices; report on medical device classification results;
certificate of eligibility to provide warranty for medical devices; letter of
authorization given by the product owner to the entity that applies for
declaration of applied standards; receipt note of declaration of applied
standards for domestically manufactured medical devices or certificate of
conformity with quality control standards which is still valid at the time of
submission of application for declaration of applied standards for imported
medical devices and documentary evidences of conformity of medical devices with
national quality standards or quality standards announced by their
manufacturers.
- Technical files: Brief technical description, sample
label used for placing medical devices on the market of Vietnam, instructions
for use.
(Further details are available in Appendix No. 3
enclosed herewith)
8.4. Contents of an inspection of medical device
trader or importer
a) Legal documents and organizational structure:
- Legal documents of the inspected entity;
documentary evidences of eligibility to import/trade in medical devices;
professional qualifications/degrees of personnel meeting corresponding
requirements for the class of medical devices; documents on organizational
structure; employment contracts, description of
each job position, and documents stating responsibilities and work relationship
of each employee.
b) Material facilities and equipment:
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c) Compliance with regulations on trading of
medical devices:
- Documents on declaration of eligibility to trade
medical devices, receipt note of application for declaration of eligibility to
trade medical devices, etc.
- Documents on purchase of goods: purchase
invoices; attached documents such as certificate of origin (C/O), customs
declaration form; certificate of quality (C/Q); warranty and maintenance
documents;
- Documents on sale of goods: sales invoices,
warranty and maintenance receipts; medical device sales and purchase contracts,
delivery records, records of finalization of contracts; logbooks of medical
devices purchased and sold.
- Documents on organization of advertisement,
seminars and events for launching new medical devices;
- Reports on rights, tax obligations and incentives
in trading of medical devices;
d) Compliance with regulations on import and export
of medical devices:
- Import license issued by the Ministry of Health
of Vietnam (for medical devices in the list of imported medical devices enclosed
with the Circular No. 30/2015/TT-BYT);
- Export documents: number of marketing
authorization for medical devices in Vietnam, satisfaction of requirements laid
down by customs authorities during export of goods.
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- Documents on import process: import contracts;
customs declaration forms; C/O and C/Q; bills of lading; invoices on purchase
of goods from foreign countries;
- Relevant documents: sales and purchase contracts
and invoices between the importer and the enterprise winning the bid for supply
of medical devices in case the inspected entity does not import medical devices
directly from importer; delivery records, test acceptance records, invoices, and
records of liquidation of contracts for supply of medical devices.
(Further details are available in Appendix No. 4
enclosed herewith)
8.5. Contents of an inspection of the entity
providing consulting or carrying out inspection and calibration of medical devices
a) Organizational structure:
- Legal documents of the inspected entity;
- Personnel: Professional qualifications/degrees,
training certificates as required by laws
- Documents on declaration of eligibility to
provide medical device technical consulting, receipt note of application for
declaration of eligibility to provide medical device technical consulting;
documents on declaration of eligibility to carry out inspection and calibration
of medical devices, receipt note of application for declaration of eligibility
to carry out inspection and calibration of medical devices;
- Certificate of conformity with standards for
laboratory and calibration facility granted to the entity providing inspection
and calibration services.
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Compliance with rules for inspection and
calibration of medical devices: list of customers using medical device
technical consulting services, scope of consulting services provided; list of inspected
and calibrated medical devices.
(Further details are available in Appendix No. 5
enclosed herewith)
8.6. Contents of an inspection of the entity
managing and using medical devices
a) Organizational structure:
- Organizational model: establishment of a medical
device department or appointment of a team or individual in charge of managing
medical devices.
- For a medical device department: functions, tasks
and organizational structure of the medical device department; operating rules
of the medical device department; annual maintenance and warranty plan;
- Personnel documents: number of employees;
in-charge person (department manager, team leader, or individual), task
assignment decisions, professional qualifications, training certificates in
management of medical devices; assignment of tasks to each employee and work
relationship among employees; training documents.
b) Documents and records:
- Documents of the inspected entity: medical device
management record; logbook of maintenance and repair of medical devices;
operating procedures of medical devices; profiles of medical device;
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c) Compliance with regulations on management of
medical devices: department or warehouse for storing medical devices
(satisfaction of hygiene, temperature and humidity requirements); profiles of
medical device (department/ward using the medical device, official in charge of
managing and using the medical device, updated information on operation,
maintenance, repair and replacement of the medical devices); instructions for
operation and use of the medical device directly attached to the medical
devices; preservation or storage of medical device and its auxiliary parts
after use as prescribed by the manufacturer; installation of safety devices for
medical devices which require safety devices.
d) Purchase, management and use of chemicals and
supplies:
- Purchase documents: bidding plan, bidding
documents, bid evaluation record, decision to approve bidding result; minutes
of the Council’s meetings to ratify the list of chemicals and supplies, their
categories and unit prices; contracts, invoices, contract finalization records,
and delivery records.
- Documents on use of chemicals and supplies:
warehousing/delivery notes; logbooks of warehousing/delivery of chemicals and
supplies; conditions for storage of chemicals and supplies.
(Further details are available in Appendix No. 6
enclosed herewith)
9. Collection of information and documents on inspection
contents
9.1. During an inspection, the head or member of
the inspection team may request the inspected entity to submit a report
according to the list of issues to be reported; request the inspected entity
and relevant authorities, organizations and individuals to provide information
and documents on the inspection contents.
A request for provision of information and
documents is made using Form No. 07-TTr enclosed with the Circular No.
05/2014/TT-TTCP.
Provision and receipt of information and documents
must be recorded in writing. A record of provision and receipt of information
and documents is made using Form No. 08-TTr enclosed with the Circular No.
05/2014/TT-TTCP.
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9.3. Management and use of inspection-related information
and documents shall comply with regulations of law on inspection and relevant
laws.
10. Verification of information and documents
10.1. The head and members of the inspection team
shall consider and examine collected information and documents for clarifying
inspection contents; evaluate the inspected entity’s compliance with policies
and laws, and performance of tasks and powers in respect to their in-charge
inspection contents; request responsible persons and relevant persons to
provide explanations about unclear issues; where the objectivity and accuracy
of information need to be verified, the member of the inspection team shall
report the case to the head of the inspection team to make a decision on such
verification.
Where it is necessary to verify collected
information and documents or clarify some issues concerning the inspection
contents, the head of the inspection team or the inspection decision maker
shall invite the inspected entity and representatives of relevant authorities,
organizations or individuals that provided information and documents to work at
their offices. The letter of invitation shall be made using Form No. 09-TTr
enclosed with the Circular No. 05/2014/TT-TTCP.
If any issues concerning the inspection contents
need to be clarified, the head of the inspection team or the inspection
decision maker shall request the inspected entity in writing to submit reports
on such issues. The request for report shall be made using Form No. 10-TTr
enclosed with the Circular No. 05/2014/TT-TTCP.
10.2. The result of verification of information and
documents concerning the inspection contents must be recorded in writing by the
authority, organization or individual whose information and documents are
verified or made into a verification record.
The verification record is made using Form No.
11-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
10.3. Results of work sessions in relation to the
inspection contents must be recorded in writing by authorities, organizations
or individuals that are invited to such work sessions or made into work
records.
The work record is made using Form No. 12-TTr
enclosed with the Circular No. 05/2014/TT-TTCP.
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When exercising their rights during inspections,
heads of inspection teams and inspection decision makers shall follow the
procedures in the Circular No. 05/2014/TT-TTCP. To be specific:
11.1. Regarding sealing of documents
Where the status quo of documents needs to be maintained,
the head of the inspection team shall make a decision to seal such documents.
Such sealing of documents shall comply with provisions of Article 36 of the
Decree No. 86/2011/ND-CP. To be specific:
a) The head of the inspection team is entitled to
make decision to seal a part or whole of documents concerning the inspection
contents. The decision to seal documents must be made in writing and clearly
indicate the documents to be sealed, sealing duration and obligations of the
inspected entity. A list of sealed documents may be made, where necessary, and
shall bear the signatures of the inspected entity and representative of the
inspection team.
b) The sealing duration shall not exceed the
duration of the physical inspection at the inspected entity’s premises. The
sealed documents shall be used with approval from the head of the inspection
team.
c) Where the sealing of documents is deemed
unnecessary, the person who issued the sealing decision shall make a decision
to invalidate that sealing decision immediately.
The decision to seal documents, decision to unseal
documents, record of sealing of documents, and record of unsealing of documents
are made using the Form No. 13-TTr, Form No. 14-TTr, Form No. 15-TTr and Form
No. 16-TTr enclosed with the Circular No. 05/2014/TT-TTCP respectively.
11.2. Regarding stocktaking of assets and goods
Where the stocktaking of assets and goods is deemed
necessary, the head of the inspection team or inspection decision maker shall
issue a stocktaking decision. Stocktaking procedures shall comply with
provisions of Article 37 of the Decree No. 86/2011/ND-CP. To be specific:
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b) Such stocktaking decision must be made in
writing and clearly indicate the subject types of assets/goods, time and
location of stocktaking, responsibilities of persons in charge of conducting
the stocktaking, and obligations of the inspected entity. The stocktaking shall
be recorded in writing. Competent authorities may be requested to the inspected
entity’s assets/goods, where deemed necessary.
c) Where the stocktaking of assets and goods is
deemed unnecessary, the person who issued the stocktaking decision shall make a
decision to invalidate that stocktaking decision immediately.
Stocktaking decision and decision to invalidate the
stocktaking decision are made using Form No. 17-TTr and Form No. 18-TTr
enclosed with the Circular No. 05/2014/TT-TTCP respectively.
11.3. Regarding request for external assessment
Where professional/technical assessment is required
as the basis for drawing the inspection conclusion, the head of the inspection
team shall request the inspection decision maker to decide to seek external
assessment. Request for external assessment shall comply with provisions of
Article 38 of the Decree No. 86/2011/ND-CP. To be specific:
a) The head of the inspection team shall request
the inspection decision maker to make a decision on external assessment.
Request for external assessment shall be made in writing and clearly indicate
the contents and time of assessment, and authority or organization requested to
carry out assessment.
b) The authority or organization carrying out the
assessment shall assume legal responsibility for the accuracy, objectivity and
timeliness of assessment results.
c) Costs of assessment shall be paid by the
authority in charge of conducting the inspection. If the inspected entity is
found to have committed violations, such assessment costs shall be incurred by
the inspected entity, unless otherwise prescribed by law.
d) Assessment costs shall be paid, managed and used
in accordance with regulations of law.
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11.4. Regarding suspension
If an action is
considered a violation and thus has to be suspended, the head of the inspection
team or the inspection decision maker shall issue a decision to suspend such
action. Such suspension procedures shall comply with provisions of
Article 39 of the Decree No. 86/2011/ND-CP.
The suspension decision must be made in writing and
clearly indicate the reasons, contents and duration of suspension, and the
entity in charge of the suspension. Where such suspension is deemed
unnecessary, the person who issued the suspension decision shall make a
decision to invalidate that suspension decision immediately.
Suspension decision and decision to invalidate the
suspension decision are made using Form No. 21-TTr and Form No. 18-TTr enclosed
with the Circular No. 05/2014/TT-TTCP.
A competent authority may be requested to suspend
the inspected entity’s action that is considered a violation, where necessary.
Such request for suspension is made using Form No. 22-TTr enclosed with the
Circular No. 05/2014/TT-TTCP.
11.5. Regarding impoundment of cash, items and
licenses
Where it is necessary to impound cash, items or
license, the head of the inspection team shall request the inspection decision
maker to issue an impoundment decision. Impoundment procedures shall comply
with the provisions of Article 40 of the Decree No. 86/2011/ND-CP.
The impoundment decision must be made in writing
and clearly indicate the cash amount, items or license to be impounded,
impoundment duration, responsibilities of the person issuing the impoundment
decision, and obligations of the entity whose cash, items or license is
impounded. An impoundment record must be made. A competent authority may be
requested to impound items or license, where necessary. Where the impoundment
is deemed unnecessary, the person who issued the impoundment decision shall
issue a decision to invalidate that impoundment decision.
The impoundment decision is made using Form No.
23-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
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11.6. Regarding recovery of money and assets
appropriated or illegally used or lost as a result of violations
Where it is necessary to recover money and assets
appropriated or illegally used or lost as a result of violations, the
inspection decision maker shall issue a recovery decision. Such recovery of
money and assets appropriated or illegally used or lost as a result of
violations shall comply with provisions of Article 42 of the Decree No.
86/2011/ND-CP.
The recovery decision must be made in writing and
clearly indicate the amount of money/asset to be recovered, responsibilities of
the authority in charge of such recovery, recovery time limit, and
responsibilities of the inspected entity.
The inspection decision maker may carry out
recovery of money or assets in accordance with regulations of law or request a
competent authority to do so. The person who issues the decision on recovery of
money/assets shall monitor, inspect and expedite the implementation of his/her
decision.
The entity whose money/asset is to be recovered
shall strictly comply with the recovery decision. If failing to do so, they
shall, depending on the nature and severity of the violation, be disciplined,
or incur administrative penalties or criminal prosecution, and pay compensation
for damage, if any, in accordance with regulations of law.
Money recovery decision and asset recovery decision
are made using Form No. 25-TTr and Form No. 26-TTr enclosed with the Circular
No. 05/2014/TT-TTCP respectively.
11.7. Regarding request for suspension of
disciplinary decisions, job transfer or retirement decisions in respect of
persons who are cooperating with inspection authorities or inspected entities
If the implementation of a disciplinary decision,
job transfer or retirement decision in respect of a person who is cooperating
with the inspection authority or is the inspected entity is found to obstruct
the inspection, the inspection decision maker shall request a competent person
to issue a decision to suspend the implementation of that decision. Such
request is made using Form No. 27-TTr enclosed with the Circular No.
05/2014/TT-TTCP.
11.8. Where it is necessary to suspend an official
or public employee who deliberately obstructs the inspection or refuses to
comply with the inspection request or decision from his/her job position and
take appropriate actions against him/her, the inspection decision maker shall
request a competent person to make a decision to suspend the violating official
or public employee from his/her job position. Such request is made using Form
No. 28-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
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12.1. If any violation is detected during the
inspection and has to be handled immediately, the head or member of the inspection
team shall make a record of violation as the basis for further actions taken.
Actions against such violation shall be taken
according to provisions of the Inspection Law and relevant laws.
12.2. In case any signs of a crime are found, the
head of the inspection team shall report the case to the inspection decision
maker to consider and make decision on such case.
13. Reporting
13.1. Each member or sub-team leader (if any) of
the inspection team shall submit reports on their performance of assigned inspection
tasks and inspection results to the head of the inspection team according to
the schedule specified in the approved inspection plan or at the request of the
head of the inspection team. Any issues that need to be dealt with immediately
should be promptly reported to the head of the inspection team for
consideration and decision.
The head of the inspection team shall consider and
give specific and direct opinions on reports received from the inspection
team’s members and give quick response to recommendations of the inspection
team’s members. Any issues falling beyond his/her authority must be reported to
the inspection decision maker for consideration.
13.2. The head of the inspection team shall submit
reports on his/her performance of assigned inspection tasks and inspection
results to the inspection decision maker according to the schedule specified in
the approved inspection plan or at the request of the inspection decision
maker.
The head of the inspection team shall send his/her
report to the person who is assigned to supervise operation of the inspection
team.
The inspection decision maker shall consider and
give specific and direct opinions on reports received from the inspection
team’s head, and give quick response to recommendations of the inspection
team’s head.
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- Performance of assigned inspection tasks by the
reporting date;
- Finished tasks and results thereof, and
in-progress tasks;
- Tasks to be performed in the next period;
- Difficulties and recommendations (if any).
14. Revisions to inspection plan
14.1. The inspection decision maker shall consider
and make decision on revisions to the inspection plan at the request of the
head of the inspection team.
14.2. The inspection decision maker may also make a
written decision on revisions to the inspection plan at his/her discretion, and
request the head of the inspection team to implement such decision.
14.3. The head of the inspection team shall notify
such revisions to the inspection plan to other members of the inspection team,
the inspected entity and relevant authorities, organizations and individuals
(where necessary), and organize the implementation of the revised inspection
plan.
15. Extension of inspection duration
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15.2. At the request of the head of the inspection
team, the inspection decision maker shall consider issuing a decision to extend
the inspection duration.
The decision to extend the inspection duration is
made using Form No. 29-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
15.3. The issued decision to extend the inspection
duration shall be sent to the inspection team, the inspected entity and
relevant authorities, organizations and individuals.
16. Transfer of documents to investigating
authorities
If the inspection decision maker decides to
transfer documents on the case where signs of a crime are found to the
investigating authority, the head of the inspection team shall direct
collection and consolidation of documents to be transferred to the
investigating authority. Such transfer of documents must be recorded in
writing.
Such transfer of documents shall comply with
regulations on cooperating relationship between inspection authorities and
competent authorities in detection, investigation and resolution of cases with
signs of a crime at request of inspection authorities.
Document on transfer of documents on the case with
signs of a crime to the investigating authority is made using Form No. 30-TTr
enclosed with the Circular No. 05/2014/TT-TTCP.
Record of transfer of documents between the
inspection authority and the investigating authority is made using Form No.
31-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
17. Termination of physical inspection at the
inspected entity’s premises
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17.2. The head of the inspection team shall report
the planned termination of the physical inspection at the inspected entity’s
premises to the inspection decision maker.
17.3. The head of the inspection team shall make a
written notice of the planned date of termination of the physical inspection at
the inspected entity’s premises and send it to the inspected entity. A work session with the inspected entity may be
organized, if deemed necessary, to notify the termination of the physical inspection. Contents of the
work session shall be made into a record of termination of the physical
inspection at the inspected entity’s premises.
The notice of termination of the physical
inspection at the inspected entity’s premises is made using Form No. 32-TTr
enclosed with the Circular No. 05/2014/TT-TTCP.
17.4. The physical inspection at the inspected
entity’s premises shall be terminated upon expiration of the inspection
duration or, if the inspection duration has not yet expired, when all contents
of the approved inspection plan have been completed.
STEP 3. TERMINATION OF INSPECTION
18. Reporting on performance of tasks by members
of an inspection team
18.1. Within 05 working days from the termination
of the physical inspection at the inspected entity’s premises, members of the
inspection team shall submit reports on their performance of assigned tasks to
the inspection team’s head and assume responsibility for the accuracy,
objectivity and truthfulness of contents of their reports.
18.2. A report on performance of tasks submitted by
a member of the inspection team shall, inter alia, include the following main
contents:
a) Assigned tasks, and inspection or verification
results;
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c) The nature, severity and causes of each
violation, and responsibilities of the violating entity;
d) Proposed consideration of the violation as an
economic, administrative or criminal case (if any); recommended solutions for
tightening and eliminating loopholes and shortcomings in performance of
management tasks, proposed revisions or amendments to mechanisms, policies and
laws; legal and practical basis for such proposals and recommendations.
18.3. If a member’s report is found inadequate or
inaccurate or needs detailed explanations, the head of the inspection team
shall request that member to modify his/her report.
19. Reporting on inspection results by the
inspection team
19.1. Based on reports received from members of the
inspection team and findings from examination of collected documents, the
inspection team's head shall play the leading role in preparing a report on
inspection results.
19.2. The report on inspection results shall be
prepared in accordance with provisions of Article 25 of the Decree No.
07/2012/ND-CP. To be specific:
Within 15 days from the date of termination of the
inspection, the inspection team’s head shall complete a report on inspection
results, unless inspection conclusions are subject to determination of a
competent authority or organization. A report on inspection results shall,
inter alia, include:
a) General overview of the inspected entity;
b) Inspection and verification results;
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d) Measures taken within the inspection team’s
jurisdiction during the inspection; proposed measures for handling violations;
recommended amendments to current regulations or promulgation of new
regulations to meet management requirements or abrogation of regulations
contrary to laws (if any);
e) Disagreements among members of the inspection
team (if any).
19.3. During the preparation of the report on
inspection results, the head of the inspection team may seek opinions from
relevant authorities, organizations and individuals, where deemed necessary, to
ensure the accuracy and objectivity of their comments, assessment, conclusions
and recommendations.
The report on inspection results is made using Form
No. 33-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
20. Consideration of report on inspection
results
20.1. The inspection decision maker shall directly
consider or appoint an assisting agency or unit to read and consider the report
on inspection results.
20.2. In case any content in the report on inspection
results needs clarifying or modifying, the inspection decision maker shall hold
a meeting with the inspection team to directly hear explanations or request the
head and members of the inspection team in writing to submit a report on the
content in question.
20.3. The inspection team’s head shall take charge
of complying with the request of the inspection decision maker; hold a meeting
of the inspection team to discuss and prepare a report on clarification or
modification of the report on inspection results.
20.4. The inspection team’s head shall submit the
report on clarification or modification of the report on inspection results, in
which any disagreements among the inspection team’s members must be specified,
to the inspection decision maker.
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21.1 After his/her receipt of the report on
inspection results and reports on clarification or modification thereof (if
any) from the inspection team, the inspection decision maker shall request the
inspection team’s head to take charge of drafting the inspection conclusion and
submit it to the inspection decision marker. The draft inspection conclusion
shall comply with provisions of clause 1 Article 27 of the Decree No.
07/2012/ND-CP. To be specific:
Based on the report on inspection results and
explanations provided by the inspected entity (if any), within 15 days from
his/her receipt of the report on inspection results, the inspection decision
maker shall issue a written inspection conclusion, unless inspection conclusions
are subject to determination of a competent authority or organization. The
inspection conclusion shall, inter alia, include:
a) Inspection and verification results;
b) Conclusions on compliance with policies and
laws, satisfaction of professional - technical standards, and performance of
tasks and powers by the inspected entity; nature, severity and causes of
violations, and responsibilities of the violating entity (if any);
c) Proposed measures for handling violations;
recommended amendments to current regulations to meet management requirements
or abrogation of regulations contrary to laws (if any).
21.2. The inspection decision maker shall directly
consider or assign a specialized agency or unit to consider and provide
opinions about the received draft inspection conclusion. Such opinions given by
the specialized agency or unit about the draft inspection conclusion must be
made in writing and included in the retained inspection dossier.
21.3. During the preparation of the draft
inspection conclusion, the inspection decision maker may request the head and
members of the inspection team to provide explanations or request the inspected
entity to provide more explanations to clarify any conclusions in the draft.
21.4. The inspection decision maker may decide to
conduct additional inspection, solicit external assessment or obtain opinions
from relevant authorities, organizations and individuals, where deemed
necessary, to ensure the accuracy and objectivity of comments, assessments,
conclusions and recommendations in the inspection conclusion.
21.5. If the draft inspection conclusion is sent to
the inspected entity to serve its explanation, the explanations provided by the
inspected entity must be made in writing and accompanied by supporting
information, documents and/or evidences.
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The head of the inspection team must submit a
report on receipt of explanations of the inspected entity and opinions given by
the appraisal unit and relevant authorities, organizations and individuals (if
any) to the inspection decision maker. This report shall be included in the
retained inspection dossier.
22. Signing and issuing the inspection
conclusion
22.1. The inspection decision maker shall consider
the report submitted by the inspection team's head and request the inspection
team's head to continue completing the draft inspection conclusion which shall
be then submitted to the inspection decision maker for signing and
promulgation.
22.2. The medical device inspection conclusion
shall be sent to the inspected entity and relevant authorities, organizations
and individuals as prescribed in clause 4 Article 27 of the Decree No.
07/2012/ND-CP and relevant regulations. To be specific:
a) If the inspection is conducted by the Ministry
Inspectorate, the inspection conclusion shall be sent to the Minister, head of
ministerial agency, Inspector-General of the Government Inspectorate, the
inspected entity, head of the supervisory authority of the inspected entity (if
any), and relevant authorities, organizations and individuals;
b) If the inspection is conducted by the
Inspectorate of a provincial Department, the inspection conclusion shall be
sent to the Director of such provincial Department, the inspected entity, head
of the supervisory authority of the inspected entity (if any), and relevant
authorities, organizations and individuals;
The inspection conclusion is made using Form No.
34-TTr enclosed with the Circular No. 05/2014/TT-TTCP.
23. Disclosure of inspection conclusion
23.1. Within 10 days from the day on which the inspection
conclusion is signed, the inspection decision maker shall organize the
disclosure of the inspection conclusion according to provisions of Article 39
of the Inspection Law and Article 46 of the Decree No. 86/2011/ND-CP. To be
specific:
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b) The inspection conclusion shall be disclosed in
the following forms:
- The inspection conclusion is disclosed at a
meeting which is held with the participation by the inspection decision maker
or his/her authorized person, representative(s) of the inspection team, the
inspected entity and relevant authorities, organizations and individuals;
- In addition to the disclosure of the inspection
conclusion at a meeting, the inspection decision maker must disclose the
inspection conclusion in at least one of these forms: publishing it on the mass
media; publishing it on the website of the inspection authority, the authority
assigned to conduct a specialized inspection or the regulatory authority of the
same level; or posting it at the headquarters of the inspected entity. Mass
media includes talking newspapers, television newspapers, printed newspapers
and online newspapers. The inspection conclusion shall be published at least 02
times on a talking newspaper or online newspaper; or be aired at least 02 times
on a television newspaper; or be appeared in at least 01 issue of a printed
newspaper.
If the inspection conclusion is published on the
website of the inspection authority, the authority assigned to conduct a
specialized inspection or the regulatory authority of the same level, it must
be published for a consecutive period of at least 05 days. If the inspection
conclusion is posted at the headquarters of the inspected entity, it shall be
posted for at least 05 days.
The inspected entity shall take charge of posting
the inspection conclusion at their headquarters. The posting duration is at
least 15 consecutive days.
23.2. The inspection decision maker shall provide the
inspection conclusion for relevant authorities, organizations and individuals
upon their request.
- Within 10 days from the day on which the
inspection conclusion is signed, the inspection decision maker shall provide
the inspection conclusion for authorities, organizations and individuals that
are involved in the implementation of the inspection conclusion.
- Based on the scope of their responsibility to
implement the inspection conclusion, the inspection decision maker shall
provide a part or the whole of the inspection conclusion for relevant
authorities, organizations and individuals.
23.3. The head of the inspection team shall assist
the inspection decision maker in making preparations for disclosure of the
inspection conclusion.
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27.1. The head of the inspection team shall hold a
meeting of the inspection team to assess the performance of the inspection team
and learn experience. The meeting minutes must be made and included in the
retained inspection dossier.
24.2. Contents of the assessment meeting of the
inspection team:
a) Assessment of the inspection results in
comparison with the objectives and requirements of the inspection;
b) Assessment of the fulfillment of
responsibilities, performance of assigned tasks, compliance with regulations on
task performance and work relationship of the inspection team, and procedures
for conducting an inspection, regulations on supervision and inspection of
operations of the inspection team, code of conduct of inspection officials, and
other regulations on operations of the inspection team;
c) Experiences learned from the inspection;
d) Recommendations on reward and commendation for
the head and members of the inspection team, and persons who have outstanding
achievements in the inspection (if any);
dd) Review and determination of responsibilities of
the head and/or member(s) of the inspection team for the violation(s) committed
during the inspection (if any);
e) Other recommendations of the inspection team (if
any).
24.3. Upon completion of the assessment meeting,
the head of the inspection team shall prepare and submit the report on
assessment results to the inspection decision maker and the head of the
authority or unit in charge of the inspection.
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The inspection dossier shall be prepared,
transferred, managed and used in accordance with provisions of Article 43 of
the Decree No. 86/2011/ND-CP and relevant regulations.
The transfer of the inspection dossier to the
archiving unit must be recorded in writing. Such record of transfer of the
inspection dossier is made using Form No. 35-TTr enclosed with the Circular No.
05/2014/TT-TTCP.
Part 3.
IMPLEMENTATION
The Inspectorate of the Ministry of Health of
Vietnam shall give instructions for development and implementation of
procedures and contents of inspection of medical devices for health
inspectorates nationwide.
Any difficulties that arise during the implementation
of this Decision but beyond the scope of this Decision should be promptly
reported to the Ministry of Health of Vietnam (via the Ministry Inspectorate)
for consideration./.
APPENDIX 1
CONTENTS OF
INSPECTION OF COMPLIANCE WITH REGULATIONS ON CLASSIFICATION OF MEDICAL DEVICES
(Enclosed with the Decision No. 7115/2016/QD-BYT dated December 01, 2016 of
the Minister of Health of Vietnam)
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CONTENTS
No
Yes
Comments
Pass
Fail
(1)
(2)
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(4)
(5)
(6)
1
ORGANIZATIONAL STRUCTURE
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Establishment and operation license
1.2
Personnel in charge of classification:
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1.2.1
Professional qualifications
1.2.2
Certification of working experience as prescribed
in Article 7 of Decree 36
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1.2.3
Certificates of completion of training courses in
medical device classification issued by qualified training institutions
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Documentary evidences of eligibility to carry out
classification of medical devices
2
DOCUMENTS ON DECLARATION OF ELIGIBILITY TO
CARRY OUT CLASSIFICATION OF MEDICAL DEVICES
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2.1
Declaration form of eligibility to carry out
classification of medical devices
2.2
Personnel list
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2.3
List of classified medical devices
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Documents on classified medical devices
APPENDIX 2
CONTENTS OF
INSPECTION OF COMPLIANCE WITH REGULATIONS ON MANUFACTURING OF MEDICAL DEVICES
(Enclosed with the Decision No. 7115/2016/QD-BYT dated December 01, 2016 of
the Minister of Health of Vietnam)
No.
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No
Yes
Comments
Pass
Fail
(1)
(2)
(3)
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(5)
(6)
1
ORGANIZATIONAL STRUCTURE
1.1
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1.1.1
Qualifications/degrees of the chief technician
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1.1.2
Certificate of experience of working directly
with medical device techniques
1.1.3
Letter of task assignment or appointment of chief
technician
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1.2
Technical staff:
1.2.1
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1.2.2
Qualifications/degrees of each technician
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1.2.3
Employment contracts signed with employees to
meet manufacturing requirements
2
MATERIAL FACILITIES
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2.1
Manufacturing workshop:
2.1.1
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2.1.2
Do equipment, and manufacturing and quality
inspection procedures meet requirements?
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2.1.3
Whether a service contract is signed with a
qualified quality inspection service provider or not (if the manufacturer
does not have adequate equipment for conducting quality inspection)?
2.2
Other requirements:
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2.2.1
Regulations on working area
2.2.2
Regulations on manufacturing area
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2.2.3
Regulations on materials and supplies storing
area
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Are these areas separated from each other?
2.3
Does the workshop
have waste and garbage treatment system?
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2.4
Is a certificate of registration of environmental
protection commitments issued by a competent authority available?
2.5
Is a certificate of satisfaction of fire
prevention and fighting requirements issued by local police authority
available?
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2.6
Regulations on occupational safety
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Warehouse:
2.7.1
Is the warehouse’s are suitable for the
categories and quantities of medical devices stored therein?
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2.7.2
Is the warehouse well ventilated, dry and clean,
and separated from sources of pollution?
2.7.3
Are storage conditions suitable for the business
scale?
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2.7.4
Are other storage requirements laid down in user
manuals satisfied?
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Vehicles used for transport of goods
2.7.6
Is a quality management system applied?
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2.7.7
Documents and contracts proving cooperation with
an entity that has warehouse and transport vehicles (if the manufacturer does
not have warehouse and transport vehicles)
3
DOCUMENTS ON MEDICAL DEVICES
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3.1
Declaration form of eligibility for manufacture
of medical devices
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Report on medical device classification results
3.3
Receipt note of declaration dossier
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3.4
Certificate of eligibility to provide warranty
3.5
Technical files, instructions for use
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3.6
Product label
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Pre-shipment inspection results
3.8
Invoices of purchase of input materials
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3.9
Regular or periodical quality inspections
conducted according to the declaration of applied quality standards of the
manufacturer
3.10
Inspection reports given by competent authorities
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3.11
Logbooks of product quality inspection results
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ADVERTISEMENT FOR MEDICAL DEVICES
4.1
Is the approval for contents of advertisement for
medical devices given by a competent authority available?
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4.2
Are the contents of advertisement for
domestically manufactured products conformable with those approved by a competent
health authority?
APPENDIX 3
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No.
CONTENTS
No
Yes
Comments
Pass
Fail
(1)
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(3)
(4)
(5)
(6)
1
ORGANIZATIONAL STRUCTURE
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1.1
Establishment license
1.2
Documentary evidences of eligibility to declare
applied standards or place medical devices on the market
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1.3
Chief technician:
1.3.1
...
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1.3.2
Certificates of completion of training courses in
medical device issued by qualified training institutions
...
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1.4
Documentary evidences of eligibility to provide
warranty
2
DOCUMENTS ON DECLARATION OF APPLIED STANDARDS
OR APPLICATION FOR MARKETING AUTHORIZATION FOR MEDICAL DEVICES
...
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2.1
Declaration form of applied standards for class-A
medical devices and number of marketing authorization for class-B, class-C or
class-D medical devices
2.2
...
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2.3
Receipt note of declaration of eligibility for
manufacturing of domestically manufactured medical devices or certificate of
conformity with quality control standards which is still valid at the time of
submission of application for declaration of applied standards for imported
medical devices
...
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2.4
Certificate of eligibility to provide warranty
for medical devices
2.5
Technical files used for repairing and
maintaining medical devices
...
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2.6
Brief technical description
2.7
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2.8
Is the domestically manufactured medical device manufactured
by an eligible manufacturer or is the imported medical device granted
certificate of conformity with quality control standards and sold in
countries in the world?
...
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2.9
Documentary evidences of conformity of medical
devices with national quality standards or quality standards announced by
their manufacturers
2.1
Letter of authorization given by the product
owner to the entity that applies for declaration of applied standards
...
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2.11
Sample label used for medical devices sold in
Vietnam
...
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CONTENTS OF
INSPECTION OF COMPLIANCE WITH REGULATIONS ON TRADING AND IMPORT OF MEDICAL
DEVICES
(Enclosed with the Decision No. 7115/QD-BYT dated December 01, 2016 of the
Minister of Health of Vietnam)
No.
CONTENTS
No
Yes
Comments
Pass
Fail
...
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(2)
(3)
(4)
(5)
(6)
1
ORGANIZATIONAL STRUCTURE
...
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1.1
Documents on organizational structure:
1.1.1
Legal representative
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1.1.2
Tax identification number
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List of technicians
1.1.4
Employment contracts
...
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1.1.5
Qualifications/certificates of training for
employees by the trader or importer (1)
2
Medical device warehouse (1)
...
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2.1
Is the premises area suitable for the business
scale?
...
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Equipment used for storing medical devices
2.3
Are technical equipment and devices sufficient
for performance of assembly, warranty and maintenance tasks?
...
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2.4
Transport vehicles
2.5
Is a service contract signed with a qualified
storage and transport service provider as prescribed in Article 37 of the
Decree No. 36/2016/ND-CP available?
...
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3
Internal regulations on fire and explosion prevention
and control; equipment used for fire and explosion prevention and control
...
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Are environmental hygiene requirements satisfied?
2
TRADING OF MEDICAL DEVICES
...
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2.1
Documents on declaration of eligibility to trade
medical devices as prescribed in Article 38 of the Decree No. 36/2016/ND-CP
2.2
Invoices on purchase/sale of medical devices
...
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2.3
Medical device sale and purchase contracts,
records of delivery of medical devices, and contract finalization records
...
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Reports on rights, tax obligations and incentives
in trading of medical devices.
3
EXPORT AND IMPORT OF MEDICAL DEVICES
...
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a
Export of medical devices
1
Number of marketing authorization for medical
devices in Vietnam
...
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2
Do warehouse and vehicles meet the requirements laid
down in Decree No. 36/2016/ND-CP?
...
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Are customs requirements for exports satisfied?
b
Import of medical devices
...
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1
Application for permission to import medical
devices
2
Product description and relevant documents as
prescribed
...
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3
Is the manufacturer's certificate of quality
standards available?
...
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Import-related documents:
4.1
Import contracts
...
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4.2
Customs declaration forms
4.3
Certificate of origin (C/O)
...
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4.4
Bills of lading
...
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DOCUMENTS ON TRADING OF MEDICAL DEVICES
1
List of annually traded medical devices
...
...
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2
Details on medical devices:
2.1
Trading/business contracts
...
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2.2
Delivery and test acceptance records, invoices,
contract finalization records
...
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Documentary evidences of origin of medical
devices as prescribed.
5
ADVERTISEMENT FOR MEDICAL DEVICES
...
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5.1
Is the approval for contents of advertisement for
medical devices given by a competent authority available?
5.2
Are the contents of advertisement for
domestically manufactured medical devices conformable with those approved by
a competent health authority?
...
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Note: (1): Requirements for trading
in class-B, class-C and class-D medical devices
APPENDIX 5
CONTENTS OF
INSPECTION OF COMPLIANCE WITH REGULATIONS ON CONSULTING, INSPECTION AND
CALIBRATION OF MEDICAL DEVICES
(Enclosed with the Decision No. 7115/QD-BYT dated December 01, 2016 of the
Minister of Health of Vietnam)
No.
CONTENTS
...
...
...
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Yes
Comments
Pass
Fail
(1)
(2)
(3)
(4)
...
...
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(6)
1
ORGANIZATIONAL STRUCTURE
1.1
Establishment license
...
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1.2
Personnel list
...
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Do personnel have appropriate
qualifications/degrees?
1.4
Other professional training certificates
...
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1.5
Has every employee entered into employment
contract?
2
DOCUMENTS ON CONSULTING, INSPECTION AND
CALIBRATION OF MEDICAL DEVICES
...
...
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2.1
Receipt note of application for declaration of
eligibility to provide medical device technical consulting
...
...
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Application for declaration of eligibility to
provide medical device technical consulting
2.3
List of customers using medical device technical
consulting services, and scope of consulting services provided
...
...
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2.4
Retained documents on completed consulting
service contracts
2.5
Receipt note of application for declaration of
eligibility to carry out inspection and calibration of medical devices
...
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2.6
Application for declaration of eligibility to
carry out inspection and calibration of medical devices
...
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Certificate of conformity with standards for
laboratory and calibration facility granted to the entity providing inspection
and calibration services
2.8
List of inspected and calibrated medical devices
...
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2.9
Invoices/receipts of inspection and calibration
service charges
2.10
Retained inspection and calibration reports
...
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3
MATERIAL FACILITIES AND EQUIPMENT
...
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Are laboratories meeting the requirements laid
down in clause 2 Article 50 of the Decree No. 36/2016/ND-CP available?
APPENDIX 6
CONTENTS OF
INSPECTION OF COMPLIANCE WITH REGULATIONS ON MANAGEMENT AND USE OF MEDICAL
DEVICES
(Enclosed with the Decision No. 7115/2016/QD-BYT dated December 01, 2016 of
the Minister of Health of Vietnam)
No.
...
...
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No
Yes
Comments
Pass
Fail
(1)
(2)
(3)
...
...
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(5)
(6)
1
ORGANIZATIONAL STRUCTURE
1.1
...
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1.2
For a medical
device department:
...
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1.2.1
Functions, tasks and organizational structure of
the medical device department
1.2.2
Operating rules of the medical device department
...
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1.2.3
Annual work plan
of the medical device department
1.2.4
...
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1.2.5
Documents and records:
...
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1.2.5.1
Shift handover logbook
1.2.5.2
Medical device management record (according to
annual stocktaking plan)
...
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1.2.5.3
Logbook of maintenance and repair of medical
devices
1.2.5.4
...
...
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1.2.5.5
Profiles of medical device
...
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1.3
Personnel:
1.3.1
In-charge person (department manager, team
leader, or individual):
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1.3.1.1
Task assignment decision
1.3.1.2
...
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1.3.1.3
Training certificates in management of medical
devices
...
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1.3.2
Department or team staff:
1.3.2.1
Number of employees
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1.3.2.2
Assignment of tasks to each employee
1.3.2.3
...
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2
RETAINED DOCUMENTS ON MEDICAL DEVICES
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2.1
Documents on purchase or investment in medical
devices, including:
2.2
Investment-related documents: decisions to grant approval,
bidding documents, meeting minutes/records, bid package, bid evaluation
record, bidding result notice, etc. as prescribed by the Bidding Law
...
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2.3
Purchase-related documents: sale and purchase
contracts, delivery records, test acceptance records, contract finalization
records, invoices, etc.
2.4
...
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2.4.1
Originals or certified true copies of documents proving
origin of medical devices (C/O and C/Q)
...
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2.4.2
Other documents (copies bearing company’s seal):
2.4.2.1
Customs declaration forms (identifying the
importer)
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2.4.2.2
Documents proving that marketing authorization
number has been granted to the medical device for being placed on the market
(1)
2.4.2.3
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3
MANAGEMENT AND USE OF MEDICAL DEVICES
...
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3.1
Area or warehouse for storing medical devices
(which must be clean, well ventilated and dry)
3.2
Are medical devices properly cleaned after use?
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3.3
Have auxiliary parts of medical devices been
stored neatly after use according to manufacturer’s manuals?
3.4
...
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3.5
Profiles of medical device (department/ward using
the medical device, official in charge of managing and using the medical
device, updated information on operation, maintenance, repair and replacement
of the medical devices)
...
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3.6
Are safety devices installed for medical devices
which require safety devices?
4
PURCHASE, MANAGEMENT AND USE OF CHEMICALS AND
SUPPLIES
...
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4.1
Decision on approval of contractor selection
result
4.2
...
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4.3
Documents submitted for approval of contractor
selection plan
...
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4.4
Other documents (copies kept by the inspected
entity):
4.4.1
Minutes of the Council’s meetings to ratify the
list of chemicals and supplies, their categories and unit prices
...
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4.4.2
Contracts, invoices, contract finalization
records, and delivery records
4.4.3
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4.5
Warehouse
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(1): Marketing authorization number or import
license issued by the Ministry of Health, for imported medical devices, or
receipt note of declaration of marketing of medical devices as prescribed in
Decree No. 36/2016/ND-CP and Appendix 1 enclosed with the Circular No.
30/2015/TT-BYT dated October 12, 2015 providing guidelines for import of
medical devices.
(2): A contract or invoice must not contain the
unit price and total amount but must contain adequate information on the medical
device (name, model and quantity).