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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 166/QD-BYT
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Hanoi, January
22, 2024
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DECISION
on Promulgation of criteria and rules for
assessment of ASEAN's Common Submission Dossier Templates (CSDT) of
non-IN-VITRO DIAGNOSTIC (non-IVD) MEDICAL DEVICE
MINISTER OF HEALTH
Pursuant to Decree No. 95/2022/ND-CP dated
November 15, 2022 of the Government on functions, tasks, powers and
organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
Pursuant to Decree No. 07/2023/ND-CP dated March
03, 2023 of the Government on amendments to Decree No. 98/2021/ND-CP dated
November 08, 2021 of the Government on management of medical devices;
Pursuant to Circular No. 19/2021/TT-BYT dated
November 16, 2021 of the Minister of Health on templates of documents and
reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021
of the Government on management of medical devices;
Pursuant to Circular No. 10/2023/TT-BYT dated
May 11, 2023 of the Minister of Health on amendments to certain Articles of
Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health
on templates of documents and reports on implementation of Decree No.
98/2021/ND-CP dated November 08, 2021 of the Government on management of
medical devices;
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At the request of the Infrastructure and Medical
Device Administration (IMDA),
HEREBY DECIDES:
Article 1. Criteria and rules for assessment
of ASEAN's common submission dossier templates (CSDT) of non-in-vitro
diagnostic (Non-IVD) medical devices shall be promulgated; Details are
prescribed in Appendices I, II and III enclosed herewith.
Article 2. This Decision comes into force
from the day on which it is signed.
Article 3. Chief of the Ministry Office;
Chief Inspector of the Ministry; Director of the Infrastructure and Medical
Device Administration (IMDA); Director Generals of Departments and
Administrations under the Ministry of Health; Directors of the Departments of
Health of provinces and central-affiliated cities and Heads of relevant agencies,
organizations and individuals are responsible for the implementation thereof.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
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CRITERIA AND RULES
FOR ASSESSMENT OF ASEAN'S COMMON SUBMISSION DOSSIER TEMPLATES (CSDT) OF NON-IN-VITRO
DIAGNOSTIC (NON-IVD) MEDICAL DEVICES
(enclosed with Decision No. 166/QD-BYT dated January 22, 2024 of the
Ministry of Health)
No
Heading
REQUIRED CONTENTS
Instructions for assessment
Documentation
1
Synopsis
of general description of medical device
1.1
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Required
information:
- Description of
introduction to the medical device.
-
Purposes/Indications
- New features
(if any) (E.g. use of nanotechnology, artificial intelligence, etc.).
- Description of
introduction to the medical device includes:
+ Name
+ Category/code of
product (based on CFS)
+ Global Medical
Device Nomenclature - GMDN code (if any)
+ Software, software
version (if any)
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- New features
(if any) (E.g. use of nanotechnology, artificial intelligence, etc.).
- Documentation of
general description of the medical device
- User manual or
technical documents issued by the product’s owner.
- Enclosures such
as: links, data sheets, instructions for use,...
1.2
Sales history of
product on the market
List of countries
in which the product was sold on the market (if any).
List of countries
in which the product was sold on the market, attached to the first year (if
any) in which the product was sold on the market.
Enclosures such as:
Certificate of Free Sales (CFS), link to number of marketing authorization,
etc. (if any)
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Purposes/Indications
Purposes and/or
indications of the medical device
If the purposes
and/or indications of the medical device is similar to those on the label or
user manual of such medical device.
Label, user manual,
etc.
1.4
Information on the
grant of marketing authorization in countries
Information about
marketing authorization of the products in EU countries, Japan, Canada,
Australia (TGA), USA (FDA), UK, Switzerland, Korea, China.
Information about
marketing authorization of the products in EU countries, Japan, Canada,
Australia (TGA), USA (FDA), UK, Switzerland, Korea, China, etc. including the
status (approved, pending approval, rejected, unregistered/non-registration,
etc., purposes, indications, initial grant date. For products granted a
certificate of marketing authorization in EU countries, the latest grant date
may be written if the initial grant date is not stated. This information may
be presented in tabular form as follows:
No
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Purposes/Indications
Status of granting marketing authorization
Date of grant
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Enclosures include
guidelines or documents proving information on the marketing authorization or
the provision of copies or links to online documents on the grant of
marketing authorization in the above-mentioned countries (if any)
1.5
Important
information regarding the safety and efficiency of the medical device
Documents signed
over the latest 5 years, including:
- Adverse events,
number of adverse events or frequency of occurrence (total number of adverse
events recorded per total number of products sold).
- Corrective
actions for ensuring the safety in the market. If there have been no adverse
events, no corrective action since selling products or over the latest 5
years, a written confirmation from the products’ owner shall be submitted.
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Brief information
on adverse events that have been occurred, containing at least a description
of the adverse events, number of adverse events or frequency of occurrence
(total number of adverse events recorded per total number of products sold).
This information may be presented in tabular form as follows:
No
Description of adverse event
Number or frequency of occurrence
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2
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3
Information on
corrective actions for ensuring the safety in the market, containing at least
date of occurrence, brief description of the event, and name of the country
or territory that took corrective action. This information may be presented
in tabular form as follows:
No
Date
Brief description of the event
Name of the country or territory
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If there have been
no adverse events, no corrective action since selling products or over the
latest 5 years, a written confirmation from the products’ owner shall be
submitted.
Indicating whether
the medical device contains one of the following ingredients:
- Human or animal
cells or tissues or their derivatives intended for use in a non-viable form –
e.g. artificial heart valves from pig or cat intestines, etc.;
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- Contain
radioactive or ionizing ingredients (e.g. X-ray); or non-ionizing (E.g.
laser, ultrasound, etc.).
Documents declaring
adverse events, number of adverse events or frequency of occurrence, corrective
actions or written confirmation of the products’ owner (consular legalization
is not required). Documents may be written in English or Vietnamese
2
Table of
conformity to essential principles: in accordance with Appendix II
(if the medical
device has been granted a marketing authorization in EU countries, a table of
conformity to essential principles may be submitted according to EU
regulations).
3
Prescription of
the medical device
3.1
Description and
presentation of characterisitics of the medical device
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- Description of
components and accessories used to help the device operate as well as
package.
- Full description
of each functional component, material or raw material of the medical device,
accompanied by a visual of the medical device in the form of a diagram,
photograph or drawing, as appropriate.
- Detailed
description of characteristics of the medical device for explaining
principles of action of the medical device, explaining basic science concepts
that make up the fundamentals of the medical device.
- Description of
components and accessories used to help the device operate as well as package
including configuration, design features of the components.
- Full description
of each functional component, material or raw material of the medical device,
accompanied by a visual of the medical device in the form of a diagram,
photograph or drawing, as appropriate.
Detailed
drescription of the medical device.
Technical documents
issued by the owner.
3.2
Instructions for
use
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All necessary
information provided from the product owner including the summary procedures,
methods, frequency, timing, quantities and preparations that must be followed
for the safe use of the medical device.
Detailed
description of the medical device (if any) or original instructions for use
issued by the owner of the medical device (enclosed with a Vietnamese
translation)
Technical documents
issued by the owner.
3.3
Contraindications
Cases in which the
medical device must not be used for reasons of patient safety shall be in
accordance with the contents stated on the label of the medical device or the
user manual of the medical device.
Diseases or cases
and patient groups for which medical devices should not be used for the
purpose of diagnosis, treatment or mitigation of disease.
Provide information
on cases for which the medical device must not be used for reasons of patient
safety, for example, due to the patient's medical history, physiological
characteristics, etc., in accordance with the contents stated on the label of
the medical device or user manual of the medical device.
Provide general
description of diseases or cases and patient groups for which medical devices
should not be used for the purpose of diagnosis, treatment or mitigation of
disease. Contraindications that are cases for which medical devices should
not be used because the risks clearly outweigh the potential benefits.
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Contraindications
(if any)
Technical documents
issued by the owner.
3.4
Warnings
Warn about specific
dangers that users need to know before using medical devices.
Provide warnings
about specific dangers that users need to know before using medical devices,
including preventive measures to protect patients from risks caused by the
use of such medical devices.
Detailed
drescription of the medical device (if any) or original instructions for use
issued by the owner of the medical device.
3.5
Cautions
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Warn users to take
necessary precautions for the safe and effective use of the medical device.
Including actions to be taken to avoid effects to the patient/user, which may
not be life-threatening or cause serious injury, but of which the user should
be aware. Cautions also warn the user of the adverse effects of using the
medical device or of misuse of the medical device and of the precautions
required to avoid such effects.
Detailed
drescription of the medical device (if any) or original instructions for use
issued by the owner of the medical device.
Technical documents
issued by the owner.
3.6
Potential adverse
effects
Possible unintended
and serious consequences for the patient/user, or side effects from using the
medical device under normal conditions
These are unwanted
and serious consequences (death, injury, or serious adverse events) that may
occur to the patient/user, or side effects from the use of the medical device
under normal conditions, which are recorded through clinical testing and
post-marketing monitoring.
Detailed
drescription of the medical device (if any) or original instructions for use
issued by the owner of the medical device.
Potential adverse
effects (if any).
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3.7
Alternative therapy
Alternative
procedures or actions for diagnosing, treating or mitigating the disease or
condition for which the medical device is intended.
Assess the
description of alternative procedures or actions for diagnosing, treating or
mitigating the disease or condition for which the medical device is intended.
Detailed
drescription of the medical device (if any).
Alternative therapy
(if any).
3.8
Materials
Description of
materials of the medical device and its characteristics for proving the
conformity with relevant essential rules.
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Regarding a non-IVD
medical device:
- Provide a list of
materials of the medical device that come into direct contact with the body
(E.g. Mucous membrane) and indirect contact with the body (e.g. circulation
of extracellular fluid (ECF)), and their chemical, biological and physical
characteristics.
- Regarding medical
devices that emit ionizing radiation, information about sources of radiation
(e.g. radioactive isotopes) and materials used to protect users and patients
from unexpected radiation must be provided.
- In cases where
there are special requirements regarding the safety of a material such as
impurities, level of residue and exposure to plasticizers such as Bis (2-
ethylhexyl) phthalate (DEHP), additional supplies should be provided
including a certificate of conformity to relevant standards, a testing
certificate, or a safety assessment report of such material. Depending on
risks incurred when exposing to these materials, additional measures may be
required, such as notifying users of the presence of these materials by
labelling the on the product.
Standards or
testing certificates or declarations of conformity to the recognized
standards applied by the product’ owner
3.9
Other relevant
specifications
Functions and
specifications of medical devices for proving the conformity with relevant essential
rules.
Functions and
specifications of medical devices including accuracy, sensitivity,
specificity of medical measuring and diagnostic devices, reliability and
other factors (if relevant); and other specifications including chemistry,
physics, electricity, mechanics, biology, software, sterility, stability,
storage, transportation and packaging for proving the conformity with
relevant essential rules.
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Other relevant
specifications (if any)
3.10
Other information
Other important
characteristics that are not mentioned above for proving the conformity with
relevant essential rules.
Other important
characteristics that are not mentioned above for proving the conformity with
relevant essential rules (e.g. biocompatibility of medical devices, etc.).
Note: in cases where the above-mentioned information is
provided in the user manual, the user manual may be used for reference
4
Synopsis of
design verification and validation
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4.1
Preclinical studies
- Information on
biocompatibility tests performed on materials used in the medical device.
- Physical
preclinical testing data, as appropriate.
- Reports on
preclinical studies on animals used to demonstrate possible effects of the
medical device on humans.
- Evidences of
electrical safety and electromagnetic compatibility.
- Sterilization
validation reports for sterilized medical devices.
- Evidences of
cybersecurity for network-connected, internet-connected or wireless medical
devices.
- Provide detailed
information on all biocompatibility tests performed on materials used in the
medical device. All significantly different materials must be described.
Description of tests, results and data analyses must be provided.
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- Provide evidences
of electrical safety and electromagnetic compatibility. For example, if the
owner declares that the product meets the requirements of IEC 60601-1 and IEC
60601-1-2, a test summary report and/or certificate of conformity must be
provided to demonstrate that the medical device meets these standards.
- Regarding
sterilized medical devices, sterilization validation reports must be
provided. If a sterilant is toxic or produces a toxic residue (e.g., Ethylene
Oxide), data and test methods must be provided to demonstrate that the amount
of sterilant or residue is within acceptable limits.
- Provide evidences
of cybersecurity for network-connected, internet-connected or wireless
medical devices. Such as: analyses of risks and possibilities of cyber
attacks, cyber security control methods, plans, processes or mechanisms for
monitoring, promptly detecting and managing security-related threats during
the life cycle of the medical device. Declarations from the manufacturer or
the owner stating that the medical device has equipped with network
connection, internet connection or wireless connection to ensure cyber
security and safety may be provided.
Documents proving
the conformity with characteristics of the product, for example:
- Biocompatibility
test reports or detailed information on test reports on all biocompatibility
tests performed on blood-contacting materials used in the medical device. All
significantly different materials must be described. Description of tests,
results and data analyses must be provided.
- Physical
preclinical testing data.
- Reports on
preclinical studies on animals.
- Electrical safety
certificates.
- Sterilization
validation reports.
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- Preclinical
studies (if not mentioned in the Clinical Report).
4.1.1
Software
verification and validation studies
List of information
about software and its versions.
The correctness of
a software product is another important characteristic of the product that
cannot be fully validated in a finished product. The product’s owner shall
list information about software and its versions (up to the date of
submission of the application). This information includes results of the
verification, validation and testing of the software done internally and in
user’s environments prior to official launch, for all different hardware
configurations such as mentioned on the label or in the product
documentation, as well as representative data obtained from both test
environments
List of information
about software and its versions.
4.1.2
Medical device
containing biological materials
Results of study
demonstrating that measures for facing dangers from infectious agents have
been fully implemented.
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- Results of study
demonstrating that measures for facing dangers from infectious agents have
been fully implemented.
- Animal tissue
risk assessment or similar document.
4.2
Clinical evidence
A clinical
evaluation report (CER) of the medical device.
Provide a clinical
evaluation report of the medical device. This evaluation report may be in the
form of a systematic review of available references, be based on clinical
experience with that medical device or similar medical device, or may be by
clinical studies. Clinical studies are often necessary for high risk medical
devices, or medical devices where there is little or no clinical experience.
A clinical
evaluation report includes purposes and context of the clinical evaluation,
input clinical data, data appraisal and analysis, conclusions about safety
and effectiveness of the medical device.
The clinical
evaluation report should contain sufficient information to be read as a
standalone document by a regulatory authority for the purposes of
considering. The clinical evaluation report should provide an overview of:
- Technology used
by such medical device, indications for use, statements about the safety and
clinical performance of that medical device, if any.
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- Clinical data and
recognized standards proving the safety and performance of the medical
device.
“a clinical
investigation report of the medical device” shall be provided, including
clinical data, clinical evaluation, clinical evidence, clinical efficiency,
etc.
4.2.1
Data collected from
existing references
Clinical evidences
of the performance shall be provided and medical device-related studies
conducted in Vietnam or other countries may be included.
If the product’s
owner uses existing studies and references to prove the safety and
performance of the medical device, copies of these documents should be
provided.
Clinical evidences
of the performance may include medical device-related studies conducted in
Vietnam or other countries. These evidences may be collected from related
studies published in international medical journals. Documents on
clinical evidences must include objectives, methods and results presented in
a clear and meaningful context. Before reaching conclusions of results of
clinical studies, discussions in context with published documents are
required.
List of existing
studies and references used to prove the safety and performance of the
medical device or clinical reports or clinical evaluation reports (CER).
4.2.2
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Clinical experience
data of the medical device or comparable devices.
Clinical experience
is clinical data obtained from clinical use of the medical device, not from
clinical studies. Clinical experience may be of the medical device or
comparable devices.
Clinical experience
may be obtained from the following data:
- Post-market
surveillance reports of the product’s owner, regulatory authorities, cohort
studies (may contain unpublished long-term study data on safety and
performance).
- Data on adverse
events occurred obtained from the product’s owner or from regulatory
authorities.
- Data obtained
from patients using the medical device in the pre-market aid program.
- Information on
clinically relevant field corrective actions such as recalls, notifications,
hazard warnings.
Post-market data
reports.
4.2.3
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Clinical
investigation data shall be provided for the purpose of assessment of safety
and performance of a medical device.
A clinical
investigation is a systematic investigation or study on or in human subjects,
undertaken to assess the safety and performance of a medical device.
The clinical
investigation may be undertaken by the medical device’s owner or by a third
party representing the owner. The clinical investigation should be designed,
conducted and reported in conformity with ISO 14155 standards, Part I and
2, Clinical Investigations of Medical Devices for Human Subjects, or in
conformity with an equivalent standard, and in compliance with regulations of
the host country.
The clinical
investigation must conform to the ethical standards of the Declaration of
Helsinki (DoH).
Study design (study
protocol) and reports on study results according to ISO 14155 (Parts 1 and
2, Clinical Investigations of Medical Devices for Human Subjects), or
equivalent standards, or standards in host countries or clinical
investigation reports or equivalent documents.
5
Labels of
medical devices
5.1
Label samples on
medical devices and packaging
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Label samples must
be presented in print, text or images, provided or attached to one or more
layers of packaging, including outer packaging and direct packaging. If it is
impossible to provide physical label samples (e.g. a large warning label
attached to an X-ray machine), the information may be provided in an
alternative form, such as an image or technical drawing.
Label samples of a
medical device must meet the requirements according to Decree No.
43/2017/ND-CP and Decree No. 111/2021/ND-CP as follows:
- The name of the
medical device: conform to the medical device applied to grant a number of
marketing authorization.
- The name and
address of the holder of marketing authorization number: consistent with the
declared content.
- The number of
marketing authorization of the medical device.
- Origin of the
medical device, in case of unknown origin, the place where the finishing
process of the medical device took place shall be written.
- The name and
address of the medical device’s owner: consistent with the declared content.
- Date of manufacture,
expiry date: for sterilized or disposable medical devices, reagents,
calibration substances, control materials, chemicals, the expiry date must be
written. In other cases, the date of manufacture or expiry date shall be
written; if the medical device is a machine/equipment, the year of
manufacture or month, year of manufacture shall be written.
- Batch number or
serial number of the medical device.
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- Instructions on
where to find warranty conditions, instructions for use of the medical
device.
For an imported
medical device, the label sample must include both the original label and the
Vietnamese secondary label (if any). The label sample must include all
products stated in the application for marketing authorization. In case the
application is submitted according to the medical device family or a system
of multiple comparable medical devices, a label sample as a representative
sample with a note of differences between label samples of the medical device
shall be submitted.
Original label (for
imported devices).
Vietnamese label
design.
5.2
Instructions for
use in Vietnamese
Instructions for
the physician or end user to use a medical device safely and for its intended
use.
Provide
instructions for the physician or end user to use the medical device safely
and for its intended use. The instructions for use should include
indications, contraindications, warnings or precautions, potential adverse
effects, alternative therapies, and conditions of storage and use to maintain
safety and performance of the medical device.
Instructions for
use of the medical device.
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Risk analysis
Results of risk
analysis
List of possible
risks for a medical device. Assessments of these risks for comparison of them
with the declared benefits of the medical device and methods used to reduce
risks to an acceptable level.
Provide a list of
possible risks for the medical device. Indirect risks from the medical device
may originate from hazards caused by the medical device, such as moving parts
causing long-term injuries, or from harms to the user, such as ionizing
radiation from an X-ray machine. Assessments of these risks for comparison of
them with the declared benefits of the medical device and methods used to
reduce risks to an acceptable level must be presented. Individuals or
organizations analyzing risks must be identified clearly. Techniques used to
analyzing risks must be defined to ensure the appropriateness to the medical
device and the risks involved.
List of risk analyses
or risk analysis reports and other documents such as: risk analysis plans,
risk analysis methods, risk analysis results (if any)
7
Manufacture
information
7.1
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Names and addresses
of the manufacturing facilities and sterilization facilities.
Names and addresses
of the manufacturing facilities and sterilization facilities of all
manufacturers participating in the processes of manufacture and sterilization
(including third-parties).
List of names and
addresses of the manufacturing facilities and sterilization facilities
(presented on the license for marketing authorization).
7.2
Manufacturing
process
Overview of the
manufacturing process
Include information
serving the general perception of the manufacturing process. No proprietary
details are required. This information can be presented in the form of a
manufacturing flow diagram that briefly describes the manufacturing process,
in-process quality control, assembly, quality control and packaging of the
final product.
If multiple
manufacturers are involved in the manufacturing process to complete a
product, it is necessary to clearly state which activities each manufacturer
is involved in.
A general
description of the manufacturing process or manufacturing diagram.
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ANNEX II
Table of conformity to essential principles
No
HEADING
REQUEST
INSTRUCTIONS
FOR ASSESSMENT
DOCUMENTATION
General requirements
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1
Medical devices must be designed and manufactured
so that when they are used under conditions and for the intended purposes,
and with the knowledge and experience of users, they will not cause damage to
health or safety of patients, users or others, provided that any risks
associated with the use of these medical devices for their intended purposes
are acceptable risks when considering benefits for patients and in accordance
with requirements for health and safety protection at a high level.
Write “Yes", if such essential principles
are applicable to the medical devices;
Write “No", if such essential principles are
not applicable to the medical devices.
If one essential principle is not applicable to
the medical devices, explanations are required. For example, if a medical
device does not contain biological materials, in the column “applicable
requirements”, write "No" and specify that the medical device does
not contain biological materials.
Technical documents proving the product meets
essential principles, e.g. certificates, study reports, test results:
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- ISO 14971
- EN ISO 18113-1
- IEC 61326-1
- IEC 61326-2-6
- IEC 60601-1
Note: accepting reports different from the
Schedule in the Appendix - Table of conformity to essential principles of
Decision No. 2426/QD-BYT.
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identify hazards and associated risks arising
from the use of the medical devices and the foreseeable misuse,
eliminate or minimize risks reasonably through
safe design and manufacturing,
For risks that cannot be eliminated, adequately
implement protective measures, including warnings where necessary, and
inform users of residual risks.
3
Medical devices must achieve the performance
intended by the medical devices’ owners and be designed, manufactured, and
packaged in such a way that, during intended conditions of use, they are
suitable for their intended purpose(s).
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The technical characteristics mentioned in
Clauses 1, 2 and 3 do not cause adverse effects to such a degree that the
health or safety of patients or users and other persons is compromised
throughout the expected life of the medical devices, when the medical devices
are subjected to the stresses which can occur during normal conditions of use
and have been maintained and calibrated according to the instructions of
medical devices’ owners.
5
Medical devices must be designed, manufactured
and packaged in a way that ensures their technical characteristics, when used
for their intended purposes, are not adversely affected during transport and
storage if the transportation and storage are carried out in accordance with
the instructions and information provided by the medical devices' owners
6
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7
Medical devices require clinical evidence,
appropriate for their use and risk classification, demonstrating that the
devices comply with the respective essential principles. The clinical
evaluation procedures must be applied.
Requirements for design and manufacturing
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Chemical, physical and biological properties
8.1
Medical devices must be designed and manufactured
in a way that ensures requirements for technical characteristics mentioned in
Clauses 1 to 6 of “General requirements” are satisfied. Particular
attention should be paid to:
the selection of materials to be used, in
particular regarding toxicity, flammability,
Physical and chemical properties of the
materials to be used,
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the selection of materials to be used must
reflect issues such as abrasion, hardness and resistance of metal.
8.2
Medical devices must be designed, manufactured
and packaged in a way that reduces risks caused by pollutants and residues
for patients and relevant persons during transport, storage and use of the
medical devices. For minimizing risks, it is necessary to pay special
attention to duration and frequency of tissue contact during transport,
storage and use of the medical devices.
8.3
Medical devices must be designed and manufactured
in a way that they can be safely used with the materials, substances and
gases to which they are exposed during normal conditions of use or in routine
procedures; If medical devices are used to deliver drugs, they must be
designed and manufactured in a way that they are compatible with the
medicinal products concerned and the action of such drugs is maintained for
their intended use.
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8.4
If a medical device contains a substance that, if
it is used separately, could be considered a medicinal product under the
relevant legislation and has the effect of supporting the action of the
medical device on the body, the safety, quality and performance of the
medical device as well as the safety, quality and effectiveness of the
combined medicinal product must be verified. The “medicinal product"
referred to herein includes stable derivatives from human blood or plasma.
8.5
Medical devices must be designed and manufactured
in a way that minimizes risks caused by substances that may seep or leak from
the medical device.
8.6
Medical devices must be designed and manufactured
in a way that minimizes risks posed by inadvertent ingress or release of
substances from the medical devices, taking into account the nature of the
environment in which they are intended to be used.
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Infection and microbial contamination
9.1
Medical devices and manufacturing processes must
be designed in a way that eliminates or minimizes, reasonably and
appropriately, risks of infection to any person. The design must:
allow for easy handling, and, where necessary:
appropriately minimize any microbial leakage
and/or microbial exposure during use;
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9.2
Where a medical device is composed of substances
of biological origin, the risk of infection must be minimized to the maximum
reasonable and appropriate degree by selecting appropriate sources, sample
donors and substances, and using validated inactivation, conservation,
testing and control procedures, as appropriate. This requirement may not be
applicable to certain in vitro diagnostic medical devices if viral activity
and infectious agents are essential to the intended use of the devices or if
being removed or inactivated, the performance of such in vitro diagnostic
medical devices will be affected.
9.3
Products made from non-living tissues, cells and
substances of animal origin that are determined to be medical devices will be
considered to have ingredients of animal origin under relevant regulations,
be subject to veterinary control and supervision for the intended use of
these tissues. The medical devices' owners should maintain information about
the geographical origin of animals. The processing, storage, inspection
and handling of tissues, cells and substances of animal origin must be
carried out in a manner that ensures optimal safety. In particular, the
safety related to viruses and other infectious agents must be achieved by
validated methods of removal or inactivation during the manufacturing
process. This requirement may not be applicable to certain in vitro
diagnostic medical devices if other viral activity and infectious agents are
essential to the intended use of the products or if being removed or
inactivated, the performance of such in vitro diagnostic medical devices will
be affected.
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For products made from cells, tissues and
derivatives of bacterial or recombinant origin that are determined to be
medical devices, the selection of sample sources/donors, processing,
preservation, testing and handling of cells, tissues and derivatives of such
origin must be carried out in a manner that achieves optimal safety. In
particular, the safety related to viruses and other infectious agents must be
achieved by validated methods of removal or inactivation during the
manufacturing process. This requirement may not be applicable to certain in
vitro diagnostic medical devices if other viral activity and infectious
agents are essential to the intended use of the products or if being removed
or inactivated, the performance of such in vitro diagnostic medical devices
will be affected.
9.5
For products composed of non-living tissues,
cells, and substances of human origin that are determined to be in vitro
diagnostic medical devices, the selection of sample sources, sample donors,
and/or substances of human origin, the processing, storage, testing and
handling of tissues, cells and substances of such origin must be carried out
in a manner that ensures optimal safety. In particular, the safety related to
viruses and other infectious agents must be achieved by validated methods of
removal or inactivation during the manufacturing process. This requirement
may not be applicable to certain in vitro diagnostic medical devices if other
viral activity and infectious agents are essential to the intended use of the
products or if being removed or inactivated, the performance of such in vitro
diagnostic medical devices will be affected.
9.6
Medical devices labelled as having a specific
microbial state must be designed, manufactured and packaged to ensure that
they remain in that state when placed on the market and remain so under the
transport and storage conditions specified by the medical devices’ owners.
9.7
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9.8
Medical devices labelled as sterile or as having
a specific microbial state must be processed, manufactured and, if necessary,
sterilized by means of appropriate and validated methods.
9.9
Medical devices intended to be sterilized must be
manufactured in appropriate and controlled conditions (e.g. environment).
9.10
Packaging for non-sterile medical devices must be
capable of keeping the medical devices at the prescribed level of
cleanliness. If medical devices need to be sterilized before use, the
packaging system should minimize the risk of microbial contamination with
consideration taken of sterilization methods of the medical devices’ owners.
Such medical devices must be manufactured in appropriate and controlled
conditions.
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9.11
Packaging and/or labelling of medical devices
must be distinguishable from identical or similar products on the market in
both sterile and non-sterile conditions.
10
Manufacturing and considerations of
environment
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If a medical device is intended to be used in
combination with other medical devices or tools, the whole combination,
including the connection system should be safe and should not impair the
specified performance of the medical devices or tools. Any known restrictions
on use applying to such combinations should be indicated on the label and/or
in the instructions for use.
10.2
Medical devices should be designed and
manufactured in such a way as to remove or appropriately reduce the:
risks of injury in connection with their
physical features and, as appropriate, mass/pressure ratio, dimensional and
design characteristics;
risks connected with reasonably foreseeable
external influences or environmental conditions, such as magnetic fields,
external electrical and electromagnetic effects, electrostatic discharge,
pressure, humidity, temperature or variations in pressure and acceleration;
risks associated with the use of the medical
devices when they come into contact with materials, substances or gases, to
which they can be exposed during normal conditions of use;
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risks of incorrect identification of samples;
risks of interference with other medical
devices normally used in investigation or treatment;
risks arising from failure to maintain or
calibrate (as with implantable devices), from aging of the materials used or
from the loss of accuracy of some measurement or control mechanism.
10.3
Medical devices must be designed and manufactured
in such a way as to minimize the risks of fire or explosion during normal use
or in case of malfunction. Particular attention should be paid to medical
devices whose intended use includes exposure to or in association with
flammable or combustible substances.
10.4
Medical devices should be designed and manufactured
in such a way as to facilitate their safe disposal of waste substances.
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11
Medical devices with a diagnostic or measuring
function
11.1
Medical devices with a measuring should be
designed and manufactured in such a way as to provide sufficient accuracy,
precision and stability for their intended purpose. The limits of accuracy,
correctness and stability should be indicated by the medical devices’ owners.
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11.2
Medical devices with a measuring should be
designed and manufactured in such a way as to provide sufficient accuracy,
precision and stability for their intended purpose, based on appropriate
scientific and technical methods. In particular, the design must address
sensitivity, specificity, correctness, repeatability, reproducibility, known
confounding factor control, and detection limits, if any.
11.3
Where the operation of medical devices depends on
the use of calibration materials and/or control materials, traceability of
values assigned to such calibration materials and/or control materials must
be ensured through a quality management system.
11.4
Any measurement, monitoring or display scale must
be designed in accordance with scientific design principles, taking into
account purposes of the medical devices.
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11.5
Whenever possible, values expressed numerically
should be in commonly accepted, standardized units, and understood by users
of the medical devices.
12
Protection against radiation
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Generally,
Medical devices should be designed, manufactured
and packaged in such a way that exposure of patients, users and other persons
to radiation is appropriately minimized in a manner that is compatible with
the intended purpose, whilst not restricting the application of levels for diagnostic
and therapeutic purposes.
12.2.
Intentional radiation
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12.2.1
Where medical devices are intended to emit
hazardous or potentially hazardous radiation, visible and/or invisible to
users, for a specific medical purpose, whose benefits to be gained are
considered to outweigh the inherent risks, and users can control such
radiation, these medical devices should be designed and manufactured to
ensure reproducibility of relevant variable parameters within an acceptable
tolerance.
12.2.2
Where medical devices are intended to emit
hazardous or potentially hazardous radiation, accessible and/or inaccessible
to users, they should be fitted with visual displays and/or audible warnings
of such emissions.
12.3.
Unintended radiation
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Medical devices should be designed and
manufactured in such a way that the exposure of patients, users and other persons
to the emission of unintended, stray or scattered radiation is appropriately
reduced as far as possible.
12.4
Instructions for use.
The operating instructions for medical devices
emitting radiation should contain detailed information as to the nature of
the emitted radiation, the means of protecting the patients and users, and
ways of avoiding misuse and of eliminating the risks during installation.
12.5
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12.5.1
Medical devices emitting ionizing radiation
should be designed and manufactured to ensure that the shape, quantity and
distribution of energy (or quality) of such emitted radiation can be changed
and controlled where possible, taking into account the intended use.
12.5.2
Medical devices emitting ionizing radiation
intended for diagnostic X-rays should be designed and manufactured in such a
way as to achieve an image and/or output quality that are appropriate to the
intended medical purpose whilst minimizing radiation exposure of patients and
users.
12.5.3
Medical devices emitting ionizing radiation
intended for therapeutic X-rays shall be designed and manufactured in such a
manner as to properly monitor and control doses used, beam types, energy and,
where possible, monitor and control the energy distribution of radiant beams.
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13
Requirements for medical devices
connected to or equipped with an energy source.
13.1
Medical devices that incorporate programmable
electronic systems, including software, should be designed to ensure the
repeatability, reliability and operability of these systems according to
their intended use. In the case of a single fault state in the system (SFC),
appropriate means shall be used to eliminate or appropriately reduce the
risks as for as possible.
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13.2
For medical devices combined with medical
software or being medical software by themselves, such software must be
evaluated on an advanced scientific-technical basis, taking into account the
principles of development life cycle, risk management, evaluation and
verification.
13.3
Medical devices for which the patients' safety
depends on an internal power source must be equipped with a power status
indicator.
13.4
Medical devices for which the patients' safety
depends on an external power supply must be equipped with an alarm system to
signal when power goes out.
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13.5
Medical devices intended to monitor one or more
clinical parameters of patients must be equipped with an appropriate alarm
system to alert users to situations that could lead to death or serious
deterioration of the patients' health status.
13.6
Medical devices shall be designed and
manufactured to appropriately minimize as far as possible risks of generating
large amounts of electromagnetism that could impair the operation of the
medical devices themselves or other medical devices located nearby.
13.7
Medical devices must be designed and manufactured
to ensure immunity to electromagnetic interference so that these devices can
function as intended.
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Protection against electrical risks
Medical devices must be designed and manufactured
in such a way that patients or anyone else are protected in the best way
against electrocution accidents when such devices are installed and
maintained in accordance with the owners' instructions, in a normal operating
condition and in a single fault condition (SFC)
14
Protection against mechanical risks
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14.1
Medical devices must be designed and manufactured
to protect patients and users against mechanical risks connected with their
use.
14.2
Medical devices shall be designed and
manufactured to minimize risks arising from vibrations generated by the
medical devices, taking account of technical progress and of the means
available for limiting vibrations, particularly at source, unless the
vibrations are part of the operation of the devices.
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Medical devices shall be designed and
manufactured to minimize risks arising from the noise emitted, taking account
of technical progress and of the means available to reduce noise, particularly
at source, unless the noise emitted is part of the operation of the devices.
14.4
Terminals and connectors to user-controlled
electrical, gas, or hydraulic and pneumatic power supplies shall be designed
and constructed to minimize any possible risks.
14.5
Accessible parts of medical devices (excluding
the parts or areas intended to supply heat or reach given temperatures) and
their surroundings should not attain dangerous temperatures under normal
conditions of use.
15
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15.1
Medical devices for supplying patients with
energy or substances should be designed and installed in such a way that the
rate and/or amount to be delivered can be set and maintained accurately
enough to ensure the safety of patients and users.
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Medical devices should be fitted with means of
preventing and/or indicating any inadequacies in the rate and/or amount of
energy delivered or substances delivered which could pose a danger. Medical
devices should be equipped with suitable means to prevent, as far as
possible, the accidental release of energy or substances at dangerous levels.
15.3
The control and indicator display functions must
be clearly specified on medical devices. Where a medical device bears
instructions required for its operation or indicates operating or adjustment
parameters by means of a visual system, such information should be
understandable to users and, as appropriate, patients.
16
Active implantable medical devices
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16.1
Active implantable medical devices must have
clear information to determine:
• Categories of medical devices;
• Medical devices’ owners; and
• Year of manufacture of medical devices.
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That information must be readable without surgery
on transplant recipients.
17
Protection against risks for patients posed by
medical devices for use or testing by lay users
17.1
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17.2
These medical devices must be designed and
manufactured in such a way as to minimize risks of error during use, and if
applicable, in the handling of testing samples and in the interpretation of
testing results.
17.3
These medical devices should, where appropriate,
include a means by which the lay users can verify that, at the time of use,
the medical devices will perform as intended by the owners.
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Information provided by medical devices’
owners
Users must be provided with information necessary
to identify medical devices, owners of medical devices, explanations for use
of medical devices in a safe manner, etc.
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19
Clinical investigation
Clinical investigations conducted on human
subjects must be based on the Declaration of Helsinki. This requirement
covers all steps in a clinical investigation from initial consideration of
the need and justification of the investigation to the publication of
results.
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APPENDIX III
REPORTS ON
ASSESSMENT OF ASEAN'S COMMON SUBMISSION DOSSIER TEMPLATES (CSDTs) OF
NON-IN-VITRO DIAGNOSTIC (NON-IVD) MEDICAL DEVICES
No
ASSESSMENT
CONTENT
ASSESSMENT
RESULT
Appropriate
Inappropriate
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1
Synopsis of general description of
medical device
1.1
Brief description of medical device
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1.2
Sales history of product on the market
1.3
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1.4
Information of the grant of marketing
authorization in countries
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1.5
Important information regarding the safety and
performance of medical device
2
Table of conformity to essential principles
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3
Prescription of medical device
3.1
Description and presentation of characterisitics
of the medical device
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3.2
Instructions for use
3.3
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3.4
Warnings
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3.5
Cautious
3.6
Potential adverse effects
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3.7
Alternative therapy
3.8
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3.9
Other relevant specifications
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3.10
Other information
4
Synopsis of design verification and validation
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4.1
Preclinical studies
4.1.1
Software verification and validation studies
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4.1.2
Medical device containing biological materials
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Clinical evidence
4.2.1
Data collected from available references
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4.2.2
Data collected from clinical experience
4.2.3
Clinical investigation data
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5
Labels of medical device
5.1
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5.2
Instructions for use in Vietnamese
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Risk analysis
Results of risk analysis
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7
Manufacture information
7.1
Manufacturer’s information
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7.2
Manufacturing process