|
MINISTRY
OF HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
---------
|
|
No.
24/2011/TT-BYT
|
Hanoi,
June 21, 2011
|
CIRCULAR
GUIDING THE IMPORT OF MEDICAL DEVICE
Pursuant to the Commercial
Law dated 14 June 2005;
Pursuant to the Law on
Quality of Products and Goods dated 21 November 2007;
Pursuant to the Government's
Decree No. 12/2006/ND-CP of 23 January 2006 detailing the implementation of the
Commercial Law regarding activities of international goods trading and
activities of goods sale and purchase agency, processing and transit with
foreign countries;
Pursuant to the Government’s
Decree No. 89/2006/ND-CP dated 30 August 2006 on labeling of goods;
Pursuant to the Government’s
Decree No. 188/2007/ND-CP dated 27 December 2007 defining the functions, tasks,
powers and organizational structure of Ministry of Health; Pursuant to the
Decision No. 10/2010/QD-TTg of 10 February 2010 on certificates of free sale
for exports and imports;
The Ministry of Health hereby
guides the import of medical device as follows:
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GENERAL PROVISIONS
Article 1.
Regulation Scope
This Circular shall regulate the
import of 100% new medical devices for circulation in Vietnam of Vietnamese
traders and the related organizations and individuals (hereinafter called the
importer).
Article 2.
Interpretation of terms
Medical device is types of
equipment, devices, materials, chemicals, including necessary software which
are used alone or in combination, for human for purpose of:
a) Prevent, monitor, diagnose,
treat, alleviate disease or compensate for an injury.
b) Investigate, replace, modify
and support for surgery during the medical examination and treatment;
c) Support and sustain life;
d) Control contraception;
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e) Specialized transport for
health activities;
Chapter II
PROVISIONS ON AUTHORITY
AND PROCEDURES FOR GRANTING LICENSE OF IMPORT OF MEDICAL DEVICE
Article 3.
Provisions on import of medical device
1. Legal conditions:
It requires the business
registration certificate or investment certificate which will set out the scope
of business of trading and importing medical device.
2. Human resource conditions:
a) The officer who are mainly
responsible for technical assistance shall meet one of the following
requirements:
- Having Bachelor’s degree in
Biomedical Electronics, Biomedical Physics; or University degree in Technology,
Medicine, Pharmacy, as well as attain certification on medical device issued by
legal medical technology training facilities or equivalent training
certificates issued by foreign countries in accordance with equipment that the
enterprise shall ask to import.
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b) Having technical cadres and
personnel capable of guiding the installation, warranty and maintenance of
medical devices related to those imported by the enterprise.
3. Conditions of facilities
- Having warehouses and other
facilities to store medical device, ensuring that the equipments shall be kept
in proper conditions as to protect from the effects of light, temperature
extremes, excessive humidity and other conditions.
- Having fire and explosion
prevention and fighting equipment and maintain a safe and hygienic environment
in accordance with the provisions of law
4. Labeling of the imported
medical device:
It must be implemented in
accordance with the regulations of the Government’s Decree No. 89/2006/ND-CP
dated 30 August 2006 on labeling of goods and Circular No. 09/2007/TT-BKHCN
dated 6 April 2007 of Ministry of Science and Technology guiding the
implementation of a number of articles of the Government’s Decree No.
89/2006/ND-CP dated 30 August 2006 on labeling of goods and several related
regulations.
Article 4.
Scope of issuing import license for medical device
1. The importer shall obtain an
import license of Ministry of Health for import of medical devices in the list
as stipulated in Appendix 1 enclosed the promulgation of this Circular.
2. Medical devices not listed in
the Appendix 1 but used for application of new diagnosis and therapeutic
methods and imported into Vietnam for the first time shall require an import
license from the Ministry of Health.
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Article 5.
Dossier and procedures for import permit of medical device
1. Dossier for import license of
medical device (1 set) includes:
a) Application form for granting
the import permit shall be signed and sealed by the managers who will be
responsible before the law or legally authorized persons in accordance with the
regulation form in Appendix 2 enclosed the promulgation of this Circular.
b) Legal Document:
Business registration
certificate or investment certificate (certified true copy/ notarized)
c) Document for import of
medical device
- Legitimate and valid ISO 13485
or ISO 9001 certification, the international recognized standard for quality
management of the producing countries, firms to the imported medical device.
- Legitimate and valid
Certificate of Free Sale (CFS) for imported medical device in the producing
countries, or Certificate to Foreign Government of FDA, or CE Mark Certificate
(original or certified copy in Vietnam or legalized by diplomatic
representative offices or Embassy of the Socialist Republic of Vietnam in the
producing countries). Minimum information in Certificate of free sale for
imported medical devices shall be in accordance with Appendix 3 enclosed with
the promulgation of this Circular.
- Legitimate and valid
authorization letter of producing firms or legal distributors for the agencies
which are allowed to import and distribute the medical devices in Vietnam
(original or certified copy or legalized by diplomatic representative offices
or Embassy of the Socialist Republic of Vietnam in the producing countries)
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- Technical description of
medical devices in Vietnamese according to the Appendix 4 enclosed the
promulgation of this Circular.
2. Dossier applying for the
import of medical devices shall be arranged in the order as stipulated in
Appendix 5 enclosed the promulgation of this Circular and must be constrained
to a set of closure for each type of equipment and clearly addressed the name
of importer and contact address in cover page. If a medical device is imported
by different producing firms and countries, their products shall have enough
documents and be arranged in the order as stipulated in the agency’s request
for issuance of the import license.
3. Procedures for requesting the
issue of licenses for import of medical device
a) For importer whose medical
device imported for the first time: They shall make the request for the issue
of import license in accordance with the instruction in Item 1 and 2, Article 5
of this Circular. The document shall be sent to the Ministry of Health
(Department of Medical Equipment & Construction) directly to the following
address: No. 138A, Giang Vo, Ba Dinh, Hanoi
- For some medical devices not
listed in the Appendix 1 but used for application of new diagnosis and
therapeutic methods and imported into Vietnam for the first time: in addition
to the conditions, the procedures of application for import permits specified
in Item 1, Article 5 of this Circular, the equipment must be accompanied with
results of clinical tests, and be appraised and permitted for import by the
Scientific and Technological Council of Ministry of Health.
For some special medical device
accepted by foreign organizations and recommended to use in countries, Ministry
of Health shall consider the exemption of clinical trial basing on the
conclusion of the Scientific and Technological Council of the Ministry of Health.
b) For importer whose medical
device imported for the second time onward: (from the effective date of this
Circular)
- The importer is not required
to submit their legal document as stipulated at point b, Article 5 of this
Circular
- If importing medical device of
the same type, same producing firm and country as issued with an import license
by the Ministry of Health, it is not required to submit the catalogue, the
technical description of medical device as defined at point c, Item 1, Article
5 of this Circular.
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Article 6.
Issuance of the import license for the medical device
1. The Ministry of Health shall assess
to issue the import license for the medical device listed in the Appendix 1
within 15 working days after receiving the adequate and regular document. In
case the import license is not been issued, Ministry of Health (Department of
Medical Equipment & Construction) will response the importing company in
written including the reason.
2. Valid time of import license:
The import license shall be valid for 01 ( one) year from the date of issue,
promulgation.
3. Fees for issuing import
license: The importer shall pay import fees in accordance with the current
regulations and as stipulated in the Decision No. 44/2005/QD-BTC dated 12 July
2005 and Decision 59/2008/QD-BTC dated 21 July 2008 of the Ministry of Finance
stipulating regime on collection, payment, management and use of the fees for
appraising conditional business activities in the health care sector, fees for
appraising standards and conditions for medical pharmaceutical practice, fees
for granting export-import licenses and medical and pharmaceutical practice
certificates.
Chapter
III
HANDLING OF VIOLATIONS
Article 7.
Handling of violations
1. In case the importer forges
or edits the dossier, documents and legal papers of Vietnamese or foreign
authorities; uses forged seal or forges a signature or seal of the importer and
related ones in the dossier for importing medical device, the Ministry of
Health (Department of Medical Equipment & Construction) shall send a
written warning to the importer and stop receiving application and considering
their import document, as following:
a) Stop receiving and assessing
the importer’s dossier for import of medical device within 03 months in the
case of a first infraction;
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c) Depending on the level of
violation, the Ministry of Health (Department of Medical Equipment &
Construction) shall send the written notice to the importer and stop receiving,
assessing the dossier for import of medical device.
Besides, the Ministry of Health
(Department of Medical Equipment & Construction) shall declare the
violation of the importer on the official website of the Ministry of Health;
inform the inspection agency, customs agency and authorized agencies for
consideration and handling in accordance with the law.
2. Depending on the level of
violation, organizations and individuals shall be sanctioned administratively
or be prosecuted for criminal responsibilities; shall compensate according to
the law in case causing material damage.
Chapter IV
IMPLEMENTATION
PROVISIONS
Article 8.
Execution responsibilities
1. Department of Medical
Equipment & Construction is a standing body of the Ministry of Health,
taking responsibilities for receiving, and submitting to Advisory Council for
Import License in medical device –Ministry of Health for assessment.
2. The inspectors of the
Ministry of Health shall be responsible for cooperating with related
departments and bureaus under the management of the Ministry of Health to
implement the inspection of business activities and import of medical device
nationwide.
3. The health department of
provinces and cities under directly Central Government shall be responsible for
implementing the inspection of business activities and import of medical device
in the locality.
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5. The importer shall
periodically report once a year (before 30 January of each year) to the
Ministry of Health (Department of Medical Equipment & Construction) on the
import of medical device (name of devices, quantities, types, producing firms
and countries, units using the equipment, import value) in accordance with the
regulations in Appendix
6 enclosed the promulgation of
this Circular.
After the annual report time,
the Advisory Council – Ministry of Health shall to assess and issue the medical
device import license based on the report of the importing company for the next
time.
In case of change of name,
transaction address of the importer, leaders, technical managers, import
managers…., the enterprises shall send a written report to the Ministry of
Health (Department of Medical Equipment & Construction) after the time of
change.
Article 9.
Validity
This Circular shall be valid
after 15 August 2011.
Repealing regulations concerning
the import of medical device as stipulated in Circular No. 08/2006/TT-BYT dated
13 June 2006 of the Ministry of Health guiding the import of vaccines, medical
biological products; chemicals, insecticides, sterilizers used in household and
health fields and health equipment facilities and Circular No.09/2006/TT-BYT
dated 11 July 2006 of the Ministry of Health on instructing the modification,
addition of section IV, appendix 9 of the Circular No.08/2006/TT-BYT dated 13
June 2006 of the Ministry of Health on instructing the import of vaccines,
health products, chemicals, insecticides, sterilizers used in household and
health fields and health equipment facilities.
In the course of implementation,
if any difficulties and problem arise, please promptly report to the Ministry
of Health (Department of Medical Equipment & Construction) for
consideration and handling./.
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To:
- Office of the Government (Department
of Science and Education, Gazette, Web Portal)
- Ministry of Justice (Legal Affairs Bureau);
- Ministries, Ministerial-level agency, Government agency;
- Ministry of Finance (Customs head office);
- Ministry of Industry and Trade (Export – Import Department);
- Minister of Health (for reporting);
- Vice-ministers of Health;
- Vietnam Medical Equipment Association;
- Vietnam medical equipment joint stock company;
- The health department of provinces and cities under directly Central
Government;
- Units under the management of Health
Ministry;
- Medical equipment importing enterprises;
- The web portal of Health Ministry;
- Archives: VT, TB-CT (03), PC (02)
ON
BEHALF THE MINISTER OF HEALTH
VICE-MINISTER
Nguyen Thi Kim Tien
APPENDIX 1:
LIST OF MEDICAL DEVICES (100% NEW) WHICH IS
IMPORTED BY IMPORT LICENSE OF MINISTRY OF HEALTH
(issued together with Circular No.24/2011/TT-BYT dated 21/6/2011of Ministry
of Health)
No.
Medical
equipment name
Diagnostics equipments
1
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2
Magnetic resonance imaging system
of various kinds
3
ultrasonic diagnosis system
4
Endoscopic diagnosis system
5
Cyclotron system,
6
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7
Auto refracto-meter, keratometer
8
electro physiological
measurement system(Electro-encephalographic, Electro-cardiographic apparatus,
Electro-mechanical)
9
Electro-retompgraph
10
bone mineral density (BMD)
measurement system
11
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12
Ultrasound fetal doppler
13
Respiratory function metering
and analyzing system
14
Biochemical testing apparatus
15
Electrolyte, Blood gas
analyzer
16
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17
Coagulation timer
18
erythrocyte sedimentation rate
(ESR) meter
19
Elisa test system
20
Blood group analyzer
21
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22
platelet aggregation &
function analyzer
23
Bacteria and virus-identifying
apparatus
24
Immune testing apparatus
Treatment equipments
25
X-ray treatment system
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Endoscope system
27
Radio-therapeutic apparatus
(Cancer treatment Cobalt machine, Linear accelerator for cancer treatment with
different energy intensity, Gammar operation knives, Close radio-therapeutic
apparatus)
28
Patient monitors of various
kinds
29
Infusion pump, electronic
syringe
30
Electronic scalpels, Laser
scalpels, Ultrasonic scalpels
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Surgical microscope
32
Assorted prostate treatment
apparatus
33
Artifical heart-lung apparatus
34
Surgical navigation systems
35
Cryosurgical system
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Infant warmer, hospital
incubator
37
Marcotizers,
Marcotizers-respirators
38
Breathing support apparatus
39
Cardiac fibrillation breakers
and pacemakers
40
Hyperbaric oxygen Chamber
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Lithotrity apparatus
42
High intensity focused
ultrasound system in cancer treatment
43
Hemofiltration apparatus
44
Ophthalmic surgical system
(laser excimer, Phemtosecond Laser, Phaco, Vitreoretinal surgery system)
45
Medical contact lense (myopia,
hypermetropia, astigmatism) and its solution
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Laser optic-treatment system
47
Implantable device (> 30
days)
48
Invasive device, instrument
used in high intensity department:
cardiovascular, neural,
skull-brain
Other equipments
49
medical gas system
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assorted ambulances;
specialized ambulance vehicles
Noted: This list in Appendix 1
is subject to be revised, added yearly by Ministry of Health (Department of
Medical Equipment and Construction) in order to meet the practical status and
suitable to the regulatory control on medical device importation.
APPENDIX 2:
APPLICATION FORM FOR IMPORT PERMISSION OF MEDICAL
DEVICE
(issued together with Circular No. 24/2011/TT-BYT dated 21/6/2011 of
Ministry of Health)
IMPORTER’S
NAME
-------
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
---------
No:
……………………..
………..,date…..month…..year…..
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APPLICATION
FORM FOR IMPORT PERMISSION OF MEDICAL DEVICE
To:
Ministry of Health (Department of Medical Equipment and Construction)
Name of enterprise that requests
import: Address:
Phone:
Fax: Director :
Phone:
Mobile: Officer in charge of import
Phone:
Mobile:
Please allow us to import
Medical device mentioned in the list below:
No
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Model
Manufacturer
Country
of manufacturer
Year
of production
Address
to send the product to Vietnam
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1. Purpose of importing:
2. Importer undertakes:
- Responsibilities for ensuring
the quality, type and quantity of medical device imported in accordance with
the application, medical device is 100% new.
- To meet the requirements,
conditions in terms of the staff responsible for technical, efficiency and
safety of medical device to users and the environment, ensure the condition of
facilities and means of transport so as not to affect the quality of imported
equipment. Ensure the requirements of trademarks of goods and equipment as
prescribed.
- To ensure the use of imported
medical device according to the application, to be subject to inspection and
supervision of related authorities.
If we offense the above
committed, we shall bear full responsibility before law.
Director
of the importer
(Sign, Sealed by)
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APPENDIX 3
MINIMUM REQUIREMENTS FOR CERTIFICATE OF FREE SALE
(CFS) OF IMPORTED MEDICAL DEVICE
Certificate of free sale (CFS)
for products of medical device are made on white paper, A4- sized, in English
and include the following minimum information:
a) Name of organization issues
CFS
b) Reference number of CFS
c)Issued date of CFS
d) Name of products or goods
which is granted CFS
e) Kind/ catergory of products
or goods which is granted in CFS
f) Name and address of
manufacturer
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h) Full name, signature and
title of the person who granted CFS and seal of the issuing organization.
APPENDIX 4:
TECHNICAL DESCRIPTION OF THE IMPORTED MEDICAL
DEVICE
(issued together with Circular No. 24/2011/TT-BYT dated 21/6/2011 of the
Ministry of Health)
No
Item
Brief
description
1
Description of the medical
device
...
...
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Description of medical device
Brief description of the principles
of operation and features, specifications of medical device; indicate if the
equipment uses new technologies, e.g : nano technology, then provide a
description of the new technologies
1.2
The list of components and
accessories (inc luding chemicals en closed)
List of components and
accessories of the medical device; for facilities that use chemicals and
reagents, list those chemicals, reagents.
1.3
Intended uses / Indications a
s labeled
Indicate intended purpose of
using/ indications on label of imported medical device.
1.4
...
...
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Brief instructions to use the
device according to written manuals or written information of imported
medical device.
1.5
Contraindications
Information on contraindications
-means the cases not to use the device because of safety for patients, for
example, medical history, physical characteristics of the patient, etc ...;
follow strictly the content approved in the producing country and on the
label of imported medical device
1.6
Warning and caution
The warning information and
caution in using medical device, including preventive measures to protect
patients avoid the risks of using the medical device, which may be the warning
information on the adverse effects or misuse and measures to prevent
1.7
Adverse effects may occur
...
...
...
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2
Circulated information of
product in countries (if any) Provides information about the countries that
approved for marketing of products, the first country to grant registration /
permitting the circulation of medical device
3
Registered indications in
other countries (if any) List registered countries together with its approved
indications for use in those countries; date of issuance of registration
4
Important safety / performance
related information
- Provide information about
the reportable adverse events related to the use of medical device;
recall/Field safety corrective actions conducted as per requirement of
regulatory authorities in countries
- If medical device containing
one of the following, a description of the following must be provided:
+ Animal or human cells,
tissues or derivatives thereof, rendered non- viable – e.g. porcine heart
valves, catgut sutures, etc.
...
...
...
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e.g.: X-rays, or non-ionizing
- for example laser, ultrasound, etc
APPENDIX 5:
THE ORDER OF FILING DOSSIER TO APPLYING PERMISSION
FOR MEDICAL DEVICE IMPORT
(issued together with Circular No. 24/2011/TT-BYT dated 21/6 /2011 of
Ministry of Health)
1. An application for import
licenses of medical device according to the form in Appendix 2 of the Circular.
2. Certificate of business
registration or certificate of investment.
3. Dossier of imported medical
device (in order for each category, companies, producing countries in the
application of import licensing unit)
a) Certificate of standards of
international quality management ISO 13485 or ISO 9001 of producers, producing
country of imported medical device
b) Certificate of free sale for
the imported medical device ;
...
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d) The description of the
product (Catalogue) of every type of imported medical device.
đ) Technical description of the
imported medical device in Vietnamese following form in Annex 4 of the
Circular.
e) The copy of Import license is
granted by the Ministry of Health (if any).
APPENDIX 6
THE ANNUAL REPORT SAMPLE FOR IMPORTED MEDICAL
DEVICE
(issued together with Circular No. 24/2011/TT-BYT dated 21/ 6/2011 of the
Ministry of Health)
IMPORTER’S
NAME
-------
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
---------
No:
……………………..
...
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ANNUAL
REPORT FOR IMPORTED MEDICAL DEVICE
To:
Ministry of Health (Department of Medical Equipment and Construction)
Name of importer: Address:
Phone:
Fax:
Import unit... reported the
importing of medical device in year of… as following:
No
Medical
device ‘s name
Model
...
...
...
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Year
of production
Date/month
of import
Organization
using the equipment
Imported
Quantity
Value
in VND
Import
Licensing of the Ministry of Health
1
...
...
...
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2
...
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...
...
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Director
of the importer
(Sign, Sealed by)