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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.
490/QD-BYT
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Hanoi,
March 01, 2024
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DECISION
ON PROMULGATION OF CRITERIA AND RULES FOR ASSESSMENT OF
ASEAN'S COMMON SUBMISSION DOSSIER TEMPLATES (CSDT) OF IN-VITRO DIAGNOSTIC (IVD)
MEDICAL DEVICES
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 Decree No.
96/2023/ND-CP dated December 30, 2023 of the Government elaborating on certain
Articles of the Law on Medical Examination and Treatment;
Pursuant to Circular No.
19/2021/TT-BYT dated November 16, 2021 of the Ministry 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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Pursuant to Decision No.
2426/QD-BYT dated May 15, 2021 of the Minister of Health on promulgation of
guidance on the preparation of ASEAN’s common submission dossier templates for
medical devices;
Pursuant to Decision No.
04/QD-BYT dated January 02, 2024 of the Ministry of Health on the designation
of units responsible for processing the general technical documentation for
medical devices in accordance with ASEAN regulations;
At the request of the Minister
of Infrastructure and Medical Device Administration (IMDA) in Statement No.
34/HTTB-DKKD dated February 19, 2024.
HEREBY DECIDES:
Article 1.
“Criteria and rules for assessment of ASEAN's common
submission dossier templates (CSDT) of in-vitro diagnostic (IVD) medical
devices shall be enclosed; details are prescribed in Appendices I, II, III and
IV 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); Heads of the units 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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APPENDIX
I
CRITERIA AND RULES FOR ASSESSMENT OF ASEAN'S COMMON
SUBMISSION DOSSIER TEMPLATES (CSDT) OF IVD MEDICAL DEVICES
(enclosed with Decision No. 490/QD-BYT dated January March 01, 2024 of the
Ministry of Health)
No
Heading
REQUEST
INSTRUCTIONS
FOR ASSESSMENT
DOCUMENTATION
1
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1.1
Brief and general description of
medical device
Description of introduction to
the medical device.
- Description of introduction to
the medical device includes:
+ Name of medical device:
+ Model;
+ Global Medical Device
Nomenclature - GMDN code (if any);
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+ Name and unique device
identifier (UDI) (if any).
Instructions for se and
comparison of related documents included in the application.
Purposes and indications.
Purposes and indications of the
device as specified in the data provided by the manufacturer on the label,
within the instructions for use of that medical device.
New features if available.
New features (if any) (E.g. use
of nanotechnology, artificial intelligence, etc.).
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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.
+ Making a list of countries in
which the product was sold on the market.
+ The time of the initial product
commercialization.
List of countries in which the
product was sold on the market
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Purposes, indications for use
Purposes, indications for use of
the medical device
Purposes, indications for use of
the medical device as stated on the label or in the device's user manual.
Label, user manual.
1.4
Information of the grant of
marketing authorization in countries
Information on the marketing
authorization status of product in the countries included in the list of the
reference regulatory agencies.
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+ Including the marketing
authorization status (approved, pending approval, rejected,
unregistered/non-registration, etc.),
+ Purposes of use,
+ Indications for use,
+ 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:
- Copies or links to online
documents on the grant of marketing authorization in the above-mentioned
countries (if any)
- The aforementioned documents
are not notarized, translated, or legalized for use in Vietnam.
No
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Purposes/Indications
Marketing
authorization status
Date
of grant
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1.5
Important information regarding
the safety and performance of medical device
Documents may be written in
English or Vietnamese
Information on adverse events
that have been occurred.
- Brief information on the
adverse events that have been occurred in the market since the product was
first launched or within the last 5 years.
- Brief information on adverse
events that have been occurred, containing at a minimum 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).
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- Documents listing adverse events,
the quantity of adverse events, or the frequency of occurrence.
- Documents listing corrective
actions.
- Written confirmation of the
product’s owner (if any).
- Information on components of
biological origin (if any).
No
Date
Description
of adverse event
Number
or frequency of occurrence
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1
2
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3
Information on corrective actions
for ensuring the safety in the market
- Brief information on corrective
actions for ensuring the safety in the market that have been taken since the
product was first launched or within the last 5 years must, at a minimum,
include: the date of occurrence, a brief description of the event, and the
name of the country or territory that implemented the corrective action. This
information may be presented in tabular form as follows:
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No
Date
Brief
description of the event
Name
of the country or territory
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If there are no adverse events,
no corrective action since the product was marketed or over the latest 5
years.
If there are no adverse events,
no corrective action since the product was marketed or over the latest 5 years,
a written confirmation from the product’s owner shall be submitted (this
document does not require consular legalization).
Other information (if any)
- Indicating whether the medical
device contains one of the following components:
+ Biologically derived
components: antigens, antibodies, enzymes, etc.
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Table of conformity to
essential principle: Documents may be written in English or Vietnamese
Table of conformity to essential principles
regarding the safety and effectiveness of medical devices issued by the
medical device owner (According to Appendix II)
Table of conformity to essential
principles regarding the safety and effectiveness of medical devices issued
by the medical device owner as prescribed in Appendix II enclosed to prove
the product is suitable to the related essential principles.
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.
Table of conformity to essential
principles regarding the safety and effectiveness of medical devices issued
by the medical device owner.
3
Prescription of the medical
device
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3.1
Description and presentation of
characteristics of the medical device
Detailed description of characteristics
of the medical device
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.
Detailed description of the
medical device or original instructions for use issued by the owner of the
medical device (enclosed with a Vietnamese translation) or technical
documentation issued by the owner.
Description of components and accessories
used to help the device operate as well as package.
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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.
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.
3.2
Intended use
Intended use of the medical
device
The intended use of the medical
device matching the data provided by the product owner in the user manual as well
as the operational capabilities of the medical device.
Label, user manual.
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3.3
Indications for use
A general description of the
pathology or condition that the medical device diagnoses or the medical
device is designed for use.
The general description of the
pathology or condition that the medical device diagnoses including a
description of the target patient group for which the medical device is
designed to be used.
Label, user manual.
3.4
Instructions for use
Instructions for use from the
product owner
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Instructions for use.
3.5
Warnings
Warnings about specific dangers
that users need to know before using medical devices.
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 description of the
medical device or original instructions for use issued by the owner of the
medical device (enclosed with a Vietnamese translation) or technical
documentation issued by the owner.
3.6
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Warning users to take necessary
precautions for the safe and effective use of the medical device.
Warnings provided to 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 description of the
medical device or original instructions for use issued by the owner of the
medical device (enclosed with a Vietnamese translation) or technical
documentation issued by the owner.
3.7
Potential adverse effects (if
any).
Possible unintended and serious
consequences for the patient/user, or side effects from using the medical
device under normal conditions
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 description of the
medical device or original instructions for use issued by the owner of the
medical device (enclosed with a Vietnamese translation) or technical
documentation issued by the owner.
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3.8
Alternative diagnostic methods
(if any).
Alternative procedures or actions
for diagnosing diseases or conditions for which the medical device is
intended.
Description of alternative
procedures or actions for diagnosing diseases or conditions for which the medical
device is intended.
Detailed description of the
medical device or original instructions for use issued by the owner of the
medical device (enclosed with a Vietnamese translation) or technical
documentation issued by the owner.
3.9
Materials (which may be listed in
English or Vietnamese
Description of materials of the
medical device and its characteristics for proving the conformity with
relevant essential rules.
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- For IVD reagents, calibrators,
controls:
+ A list of all the materials
used in the production of the product, including: Name of material and its
role in the finished product.
+ Information about the components,
biological characteristics, and origins of the materials involved in
reactions or testing: antigens, antibodies, enzymes, multiplex PCR, PCR
primers, probes, calibrators, controls, etc. is provided, excluding
information related to the confidentiality of the manufacturer or copyright
protection such as amino acid sequences, spatial structures of antigens,
antibodies, sequences of primers, probes, stabilizing components (The
manufacturer is responsible for this information).
- For medical devices containing
substances requiring special control (narcotics or radiation-producing
materials, either non-ionizing or ionizing), it is required to provide
adequate information about the composition, content and role of these
substances, for example, Buprenorphine in drug testing kits, Iodine-131 in
radioimmunoassay kits, Phosphorus-32 (32P) -labeled DNA probes in
Southern blot methods, etc.
- For class C and class D IVD
medical devices: Information on the standards or test reports of the main
materials involved in the reactions (excluding stabilizers) is provided. The
information described for each active material (antigen, antibody, multiplex
PCR, etc.) is provided. Excluding information related to the manufacturer's
confidentiality or copyright protection such as amino acid sequences, spatial
structure of antigens, antibodies, sequences of primers, probes, and
stabilizing components (The manufacturer is responsible for such
information).
- List of all materials used.
- Information about the composition,
biological characteristics, and origins of materials involved in the
reactions.
- Standards or test reports of
the main materials involved in the reactions.
- For medical devices containing
substances that require special control: complete information on the
composition, content, and role of these substances must be provided.
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3.10
Other relevant specifications
Characteristics of the functions
and technical specifications regarding the operation of medical devices.
Characteristics of the functions
and technical specifications regarding the operation 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.
Reports or declarations of
conformity to the recognized standards applied by the product’ owner.
Other relevant specifications (if
any)
3.11
Other information (if any)
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Other important characteristics
that are not mentioned above for proving the conformity with relevant
essential rules (for example: The biocompatibility of medical devices, etc.).
4
Synopsis of design
verification and validation
Documents may be written in
English or Vietnamese
Information in this section
should be summarized or be used for reference or contain design verification
data and design validation data, appropriate to the complexity and risk
classification of the medical device.
Information in this section
should be summarized or be used for reference or contain design verification
data and design validation data, appropriate to the complexity and risk
classification of the medical device.
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- Certificates or declarations of
conformity to the recognized standards applied by the product’ owner.
- Summaries or test reports and
evaluations based on other standards, methods and tests of the manufacturer,
or other means to demonstrate compliance with the product standards.
E.g. If the Table of
conformity to essential principles mentions that the manufacturer uses a
recognized standard to demonstrate conformity with an essential principle, a
Declaration of Conformity to that standard must be provided, or a certificate
of conformity, and a summary of the test data if that standard does not
include performance requirements.
Summaries of data or test reports
and evaluation, depending on the complexity and classification of the risk level
of medical devices, typically include:
- The list and conclusions drawn
from published reports related to the safety and efficacy of medical devices
in accordance with the essential principles;
- Technical tests;
- Laboratory tests;
- Using under simulated
conditions.
- Software evaluation.
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4.1
Preclinical studies (if
applicable)
Physical preclinical testing
data, as appropriate.
- Physical preclinical testing
data, as appropriate. A report must include objectives, methods, results and
conclusions of the product’s owner for all physical studies of the medical
device and components. Physical testing shall be performed to forecast the
adequate response of the medical device to physical pressure, adverse
conditions and effects, long-term use and all known and probable causes of
device failure.
- Physical preclinical testing
data.
- Electrical safety certificates.
- Sterilization validation
reports.
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- Other preclinical studies (if not
mentioned in the Clinical Report).
Evidences of electrical safety
and electromagnetic compatibility.
- 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.
Sterilization validation reports.
- 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.
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- 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.
4.1.1
Software verification and
validation studies (if applicable)
Evidence confirming the software
design and development process.
- The correctness of a software
product is another important characteristic of the product that cannot be
fully validated in a finished product. The product owner must provide
evidence confirming the software design and development process.
- 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
user manual, as well as representative data obtained from both test
environments.
- Software version
- An overview of the
verification, confirmation, and testing conducted for the software.
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List of information about
software and its versions.
4.1.2
Medical device containing
biological materials (if any)
Study results demonstrating that
measures for facing dangers from infectious agents have been fully
implemented.
Study results demonstrating that
measures for facing dangers from infectious agents have been fully
implemented. This section will include results of removing viruses and known
hazards. Concerns about screening of donors must be fully addressed and
methods of obtaining human material should be fully described. Results of
process validation are required to demonstrate that manufacturing processes have
been applied to minimize biological risks.
Study results demonstrating that
measures for facing dangers from infectious agents have been fully
implemented.
4.2
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4.2.1
Analytical performance
- Analytical performance
study report of the medical device.
- Information on the specimens
used for assessment.
1. Analytical study - Preclinical
phase
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Information about the types of specimens
that may be used with the IVD:
- Identify the different specimen
types that can be used with this product, including detailed information for
each matrix and any anticoagulants present.
- Provide researches and
validated information to substantiate the specimen types used (and the
anticoagulant, if applicable).
- Provide researches and
validated information to support claims regarding the stability, storage and
shipping conditions (if applicable) for each specimen type.
1.2. Analytical performance
characteristics (suitable for each type of test)
- Hematology tests require the
provision of information on repeatability, reproducibility, trueness, linear
interval, quantification limits, interfering factors, sensitivity,
specificity as appropriate, etc.
- Biochemical and immunological
tests require the provision of information regarding repeatability,
reproducibility, reference interval, linear interval, quantification limits,
sensitivity, specificity, etc.
- Microbial culture and isolation
require the provision of information regarding the test results that
correspond to the quality assessment criteria.
(i) Accuracy of the
method
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The trueness of the method is
influenced by systematic errors, which are typically expressed in terms of
bias, while the precision of the method is affected by the standard
deviation. The accuracy is influenced by both systematic and random errors
that contribute to the overall error of the method.
(ii) Trueness of the method
- The trueness of the method
applied to quantitative and qualitative IVDs is only valid when reference
standards or methods are available.
- Providing researches and
validated information to establish trueness.
(iii) Precision
This section includes studies on
repeatability and reproducibility.
(iv) Repeatability
This section includes
repeatability calculations and information on studies used to evaluate
repeatability and within-run variability when appropriate.
Providing researches and
validated information to determine the within-run variability. These studies
use samples (representing the entire range of expected analyte
concentrations) that can be measured by products as claimed by the
manufacturer.
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Therefore, for IVD devices for
rapid and point-of-care testing, it is necessary to present studies that
determine repeatability when representatives of the proposed target group
(who are not professionally trained in testing) perform the test according to
the product’s instructions without any additional support.
(v) Reproducibility
This section includes
reproducibility calculations and information about the studies used to
evaluate reproducibility and between-run variability, between-day
variability, between-site variability, between-lot variability,
between-operator variability, and between-instrument variability as
appropriate. This variability is also referred to as intermediate precision.
Providing researches and
validated information to determine the between-run variability, between-day
variability, between-site variability, between-lot variability,
between-operator variability, and between-instrument variability. These
studies use samples (representing the entire range of expected analyte
concentrations) that can be measured by products as claimed by the
manufacturer.
With products for rapid and
point-of-care testing, in cases where these tests are performed by
individuals who are not trained in testing (such as clinical nurses, etc.),
the reproducibility should be established through two steps: At the first
step, a professional testing staff will conduct the test to determine the
optimal repeatability of the IVD under controlled testing conditions; at the
second step, the test will be conducted by a user to assess the product's
effectiveness when being performed by an untrained individual, without
support, solely following the product's instructions.
Therefore, for IVD devices for
rapid and point-of-care testing, it is necessary to present studies that
determine reproducibility when representatives of the proposed target group
(who are not professionally trained in testing) perform the test according to
the product’s instructions without any additional support.
(vi) Analytical sensitivity
This section includes detailed
information about the design and research results to evaluate the analytical
sensitivity of IVD.
Providing researches and
validated information to determine analytical sensitivity, including:
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- The number of test replications
evaluated at each concentration.
- Description of the calculation
method used to determine the sensitivity of the test.
With quantitative testing,
determining the following parameters and providing detailed information on
the basis for identifying these parameters:
- Limit of blank (LoB) is defined
as the standard deviation of the mean value of the blank (in the absence of
the analyte).
- Limit of detection - LoD is the
lowest concentration of an analyte in a specimen that can be distinguished
from the absence of that analyte (a blank value) depending on the measurements
of the specimens containing the analyte.
- Limit of quantitation - LoQ is
the lowest concentration of an analyte in a specimen that can be
quantitatively determined with acceptable precision and accuracy according to
established standards.
(vii) Analytical specificity
This section presents studies on
the influencing factors and cross-reactions to determine the analytical
specificity. The analytical specificity is the ability of an assay to detect
or quantify an analyte in the presence of other substances or agents in the
specimen. Whenever possible, the research should assess the impact of
substances or factors that may be encountered in relation to the intended
use.
E.g. According to the WHO,
it is essential to consider the common causes of infections and the
treatments for those infections in the member countries of the WHO, including
countries in Africa and Asia.
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- Type of substance/agent and
concentration.
- Specimen type.
- Concentration of the analyte.
- The study design includes the
interfering substances and the substances/factors that cause cross-reactivity
appropriately. These substances will vary depending on the type of test, the
design and may be of exogenous or endogenous origin. A typical example is the
study of the influencing factors by adding substances that may cause an
effect to the specimen and identifying any errors of the reagent compared to
the control sample and when no interfering substances are added.
- The common influencing factors
and substances/factors that cause cross-reactivity include:
+ Substances used to treat the
patients (such as therapeutic drugs, anticoagulants, etc.)
+ Substances ingested by the
patients (such as over-the-counter medications (OTC), alcohol, vitamins,
food, etc.))
+ Additives used during specimen
preparation (such as preservatives, stabilizers).
+ Substances related to special
specimens (such as hemoglobin, lipids, bilirubin, proteins).
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+ Factors that influence or cause
cross-reactivity should be assessed for the probability of a false positive
(using specimens that do not contain the analyte) and the probability of
false negative (using specimens that contain the analyte at low
concentrations reacting on IVD).
(viii) The traceability of the
values for calibrator and trueness control
This section provides detailed
information regarding the traceability of the values for calibrator and
accuracy control provided as part of the testing (if applicable) and used
during the manufacturing process.
E.g. The methods and
acceptance criteria for the traceability regarding reference materials and/or
reference measurement procedures, along with a description of value
assignment and validation.
Note: An accuracy control
is used to determine the reproducibility of a process that does not require
an assessment of traceability with reference materials or reference methods.
(ix) Measurement range of the
assay
This section provides information
on studies that define the measurement limits of tests (both linear and
nonlinear measurement systems), including LoD, and presents how these
parameter values are determined.
Providing researches and
validated information, including:
- Description of the specimen
type, the quantity of specimens, the number of replicates, and the specimen
preparation method.
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- If available, description of
the high hook effect and the data on the steps to mitigate this effect (for
example: Dilution).
(x) Validation of assay cutoff
This section provides information
on how the cut-off values for the tests are determined.
Providing researches and
validated information, including:
- The accompanying analytical
data presents the study design, including the methods to determine the
cut-off values for the tests.
- Study population (demographics/
inclusion criteria/ exclusion criteria/ number of individuals included).
- Methods or approaches for
determining the characteristics of the specimen.
- Statistical methods (e.g.,
using ROC) are employed to produce results and, if possible, to identify the
gray zone and equivocal zone.
(xi) Validation of the testing
process - reading time
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1.3. Robustness study in
accordance with each type of test.
This section provides information
that demonstrates the product design is robust (for example, being insensitive
to environmental changes and during use). Robustness studies are designed to
place devices under challenging conditions to identify any defects, if
present, in the devices, including the likelihood of the device failure and
to ascertain the roughness of the products.
Manufacturers must pay attention
to users of the devices with varying levels of skill, as well as be mindful
of potential issues that may arise with the devices and the reagents. Below is
a list of factors to consider when conducting a roughness study:
- Operator error (human
factor): using incorrect specimen type, using improper specimen for the
device (for example, placing the specimen incorrectly, incorrect specimen
volume), using the wrong reagents, positioning the device improperly (for
example, placing the machine on an uneven surface), misplacing the reagents
(including test strips/trays and other components containing the reagents),
using inappropriate reagents (for example, reagents that are not specific to
the device), following incorrect sequence of introducing reagents, using
inappropriate amount of reagents, following inaccurate timing of the
procedure (such as introducing the specimen, running the test, reading the
results), and misreading the test results.
- The integrity of the
sample: errors in specimen collection, errors in the use of
inappropriate anticoagulants or frozen specimen, errors in specimen
processing or specimen shipping and storage, presence of interfering substances
in the specimen, presence of air bubbles in the specimen, etc.
- The integrity of the reagents:
improper storage of the reagents, use of expired specimens, incorrect mixing
of the reagents, use of contaminated reagents, etc.
- The integrity of hardware,
software and electronics: power failure, abnormal power fluctuations,
incorrect voltage, and failure of hardware/software/ electronics, etc.
- The stability of calibrators
and internal controls: factors affecting calibrators and internal controls.
- Environmental factors: the
influence of key environmental factors (temperature, humidity, changes in
atmospheric pressure, light, surface, movement of devices, etc.) on the
reagents, specimen and test results, etc.
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Providing study reports on the
analytical performance of the medical device.
4.2.2
Stability
- The stability study report,
including both real-time shelf-life (storage) stability and accelerated
shelf-life (storage) stability (if applicable).
- The in-use stability study
report of products that are repeatedly used after opening.
- The study report on the
stability during the shipping under real or simulated conditions.
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- The in-use stability study
report of products that are repeatedly used after opening.
- The shipping stability study
report, in which the product is shipped under real or simulated conditions.
Stability study reports must
include objectives, methods, results, and conclusions.
Stability study reports
- Claimed shelf life: This
section will provide information about stability studies conducted to support
the claimed shelf life for the device. The test must be performed on at least
three different lots produced under conditions that are essentially
equivalent to routine manufacturing conditions. These three lots do not need
to be consecutive lots. Accelerated studies or extrapolated data from
real-time data are acceptable for initial shelf life claims but need to be
followed up with real-time shelf-life stability studies. Such detailed
information should describe:
+ The study report (including
protocol, number of lots, acceptance criteria and testing intervals)
+ When accelerated studies
have been performed in anticipation of the real time studies, the method used
for accelerated studies;
+ Conclusions and claimed shelf
life.
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+ The study report (including the
protocol, acceptance criteria and testing intervals);
+ Conclusions and claimed in use
stability.
- Shipping stability: This
section should provide information on shipping stability studies for one lot
to evaluate the tolerance of products to the anticipated shipping conditions.
Shipping studies can be done under real and/or simulated conditions and
should include variable shipping conditions such as extreme heat and/or cold.
Such information should describe:
+ The study report (including the
protocol, acceptance criteria);
+ Method used for simulated
conditions;
+ Conclusion and recommended
shipping conditions.
4.3
Clinical evidence for IVD
reagents, calibrators, controls
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- 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.
+ Nature and scope of the
clinical data to be evaluated.
+ Clinical data and recognized
standards proving the safety and performance of the medical device.
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Data collected from available
references
Clinical evidences of the
performance may include medical device-related studies conducted in Vietnam
or other countries.
- 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.
Clinical evaluation reports
(CER), on the basis of existing studies and references used, proving the
safety and performance of the medical device.
4.3.2
Data collected from clinical
experience
Clinical experience data of the medical
device or comparable devices.
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- 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.
Report on data collected from
clinical experience (if applicable)
4.3.3
Clinical investigation data
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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.
For an IVD medical device:
Clinical studies are research conducted to establish or validate the clinical
performance of IVD medical devices. Manufacturers must provide clinical
evidence to support their clinical claims, including: diagnostic sensitivity
(clinical sensitivity) and diagnostic specificity (clinical specificity).
Study protocol and detailed
report on clinical study results.
5
Labels of medical device
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Label samples on the medical
device and packaging
Label samples must meet the
requirements according to Decree No. 43/2017/ND-CP and Decree No.
111/2021/ND-CP.
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:
- Name of 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.
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- Batch number or serial number
of the medical device.
- Warnings, instructions for use,
instructions for storage, warranty conditions: they are possibly shown
directly on the label of the medical device or instructions on where to find
them.
- 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.
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, a label
sample as a representative sample with a note of differences between label
samples of the medical device shall be submitted.
- Original label design (for
imported devices).
- Vietnamese label design of
product
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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.
- For an IVD medical device, the
instructions for use include the following information (if applicable):
- Type and code (if any) of the
IVD medical device.
- Intended uses:
+ What is detected or measured;
+ Its function (e.g. screening,
monitoring, diagnosis or aid to diagnosis, prognosis, predicting);
+ Use of the same medical device
(testing machine) whether it is automated or not;
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+ The type of specimen(s)
required (e.g. serum, plasma, whole blood, tissue biopsy, urine);
+ Testing population.
- Instructions: the product is
used for IVD.
- The intended user (lay person
or professional, etc.);
- The principle of the assay.
- Description of reagents,
calibrators, reference materials, controls and limitations associated with
their use (e.g. intended for use with a specific testing machine only).
- A list of provided materials
and a list of specially required materials that are not provided.
- For IVD medical devices used in
conjunction with other medical devices and/or in combination with non-medical
devices or instruments:
+ Information for identifying these
devices or instruments, including important performance characteristics.
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- Special storage conditions
(e.g. Temperature, light, humidity and the conditions under which medical
devices are used, if applicable.
- The in-use stability may
include storage conditions and the shelf life after the first opening;
storage conditions and the stability of working solutions, if applicable. The
product's lifespan must be clearly stated in the user manual.
- If a medical device is provided
in a sterile form, it is necessary to specify that the medical device is
sterile, the sterilization method, and the handling instructions in the event
that the sterile packaging is damaged prior to use.
- The information that allows
users to be informed about any warnings, precautions, necessary measures to
be taken, and usage restrictions for an IVD medical device. This information
should include, if applicable:
+ Warning, precautions and/or
measures to be taken in the event that the IVD medical device is damaged or
malfunction or degradation reflected through the change in the external form
of the medical device may affect performance.
+ Warnings, precautions and/or
measures to be taken regarding exposure to foreseeable external influences or
environmental conditions, such as external magnetic fields, electricity and
electromagnetic forces, electric discharges, radiation associated with
diagnostic or therapeutic procedures, pressure, humidity, or temperature;
+ Warnings, precautions and/or
necessary measures to be taken regarding potential risks during the use of
the medical device in specific diagnosis, evaluation and treatment (e.g.,
electromagnetic interference emitted by the device affecting other devices);
+ Precautions related to
materials incorporated into the medical device that contain carcinogens,
mutagens or substances harmful to reproduction, endocrine disruptors, or
substances that may cause sensitivity or allergic reactions in patients.
- Conditions for collecting,
handling and preparing specimen.
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- The necessary information to
determine when IVD medical device is properly installed and ready to operate
safely and as intended by the owner, along with the following information,
when applicable:
+ Details about the nature and
frequency of preventive maintenance and scheduled maintenance, including
cleaning or disinfection;
+ Consumables and how to replace
them;
+ Information regarding the
calibration that needs to be performed to ensure that medical device operates
correctly and safely throughout its lifecycle;
+ Measures to mitigate risks for
individuals involved in installation, calibration or repair, such as
contaminated surfaces.
- Recommendations on the quality
control process when necessary.
- Instructions on how to retrieve
the values assigned to calibrators and controls, including information for
identifying reference materials and the reference measurement procedures
used.
- The process of conducting tests
includes calculating and interpreting results and recommending additional
confirmatory tests if appropriate.
- The analytical performance
characteristics, such as sensitivity, specificity and accuracy (which is a
combination of trueness and precision).
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- Reference range when
applicable.
- Information about interfering
substances or limits (e.g., visual evidence of hyperlipidemia or hemolysis,
the specimen storage duration) may affect the execution of the analysis.
- Warnings or precautionary
measures to be taken regarding the disposal of equipment, accessories, and
consumables used together, if any. This information should include the
following contents, if applicable:
+ The dangers of infection or
microorganisms (e.g., consumables contaminated with infectious substances of
human origin);
+ Environmental hazards (e.g.,
batteries or materials emitting potentially dangerous radiation);
- Physical hazards (e.g.,
explosions).
- For IVD medical devices used by
non-professionals, it is necessary to advise users to seek the opinions of
healthcare professionals before making any medical decisions.
- References, if applicable.
- The name and address of the
owner must be presented in a recognizable format that allows for the
identification of the owner's information. In cases where the user manual
contains information about the manufacturing facility and origin, this
information must include complete details regarding the name and address of
the manufacturing facility.
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Medical device user manual
6
Risk analysis (which may be
conducted in either Vietnamese or English)
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.
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List of risk analyses and other
documents such as: risk analysis plans, risk analysis methods, risk analysis
results (if any)
7
Information regarding
production (which may be stated in Vietnamese or English)
Providing summaries or references
or documents related to the production processes, including quality assurance
measures, in accordance with the complexity and risk classification of
medical devices.
7.1
Manufacturer’s information
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The names and addresses of the
manufacturers participating in the processes of manufacture and sterilization
(including third-parties).
List of names and addresses of
manufacturers
7.2
Manufacturing process
Overview of the manufacturing
process
- 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. Information
pertaining to the quality inspection 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
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- The process of quality control
for finished products.
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APPENDIX II
Table of
conformity to essential principles
(enclosed with Decision No. 490/QD-BYT dated March 01, 2024 of the
Ministry of Health)
No
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REQUEST
INSTRUCTIONS
FOR ASSESSMENT
DOCUMENTATION
General requirements
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.
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Technical documents proving the
product meets essential principles, e.g. certificates, study reports, test
results, etc.
The applicant is fully
responsible before the law for the content of this table of conformity.
2
Solutions of medical devices’
owners for design and manufacture of medical devices must be in accordance
with safety principles and take into account the level of scientific and
technical development. During the process of selection of suitable solutions
for design and manufacture of the medical devices, in order to minimize risks
associated with the use of these medical devices, the owners must:
• 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.
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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).
4
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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Benefits to be gained must
outweigh any undesirable effects for the performance intended.
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
8
Chemical, physical and biological
properties
8.1
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• The selection of materials to
be used, in particular regarding toxicity, flammability,
• Physical and chemical
properties of the materials to be used,
• The compatibility between the
materials to be used and biological tissues, cells, body fluids, and
specimens, taking into account the intended purposes of the medical devices,
• 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
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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.
9
Infection and microbial
contamination
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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;
• Minimize the transfer of
contamination from patients, users or other persons to the medical devices or
specimens and vice versa during use.
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.
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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.
9.4
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.
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Medical devices labeled 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
Medical devices delivered in a
sterile state must be designed, manufactured and packaged to ensure that they
are sterile when placed on the market and remain sterile under the transport
and storage conditions specified by the medical devices’ owners.
9.8
Medical devices labeled 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
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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.
9.11
Packaging and/or labeling 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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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.
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.
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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.
11.5
Whenever possible, values
expressed numerically should be in commonly accepted, standardized units, and
understood by users of the medical devices.
12
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12.1
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.
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Intentional radiation
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
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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.
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12.5
Ionizing radiation.
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.
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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.
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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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.
13.5
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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.
13.8
Protection against electrical
risks
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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
14.1
Medical devices must be designed
and manufactured to protect patients and users against mechanical risks
connected with their use.
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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.
14.3
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
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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
Protection against risks posed to
patients by medical devices supplying energy or substances
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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15.2
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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Active implantable medical
devices must have clear information to determine:
• Categories of medical devices;
• Medical devices’ owners; and
• Year of manufacture of medical
devices.
16.2
That information must be readable
without surgery on transplant recipients.
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Protection against risks for
patients posed by medical devices for use or testing by lay users
17.1
These medical devices must be
designed and manufactured in such a way as to ensure that they perform appropriately
for their intended purpose, taking into account the skills and the means
available to lay users and the influence resulting from variations that can
be reasonably anticipated in the lay users' technique and
environment. The information and instructions provided by the
medical devices’ owners should be easy for the lay users to understand and
apply.
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.
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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.
18
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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REPORT ON ASSESSMENT OF ASEAN'S COMMON SUBMISSION
DOSSIER TEMPLATES (CSDT) OF IVD MEDICAL DEVICES
(enclosed with Decision No. 490/QD-BYT dated January March 01, 2024 of the
Ministry of Health)
No
ASSESSMENT
CONTENT
Result
Appropriate
Inappropriate
Not
applicable
1
Synopsis of general
description of medical device
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1.1
Brief description of medical
device
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Sales history of product on the
market
1.3
Purposes, indications for use
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1.4
Information of the grant of marketing
authorization in countries
1.5
Important information regarding
the safety and performance of medical device
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2
Table of conformity to
essential principles
3
Prescription of medical device
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3.1
Description and presentation of
characteristics of the medical device
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Uses
3.3
Indications for use
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3.4
Instructions for use
3.5
Warnings
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3.6
Cautious
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Potential adverse effects
3.8
Alternative diagnostic methods
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3.9
Materials
3.10
Other relevant specifications
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3.11
Other information
4
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4.1
Preclinical studies (if
applicable)
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4.1.1
Software verification and
validation studies (if applicable)
4.1.2
Medical device containing
biological materials (if any)
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4.2
Preclinical studies for IVD
reagents, calibration substances, control materials:
4.2.1
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4.2.2
Stability
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4.3
Clinical evidence for IVD
reagents, calibration substances, control materials
4.3.1
Data collected from available
references
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4.3.2
Data collected from clinical
experience
4.3.3
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5
Labels of medical device
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Label samples on the medical
device and packaging
5.2
Instructions for use in
Vietnamese
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6
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
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REFERENCES
(Enclosed with Decision No. 490/QD-BYT dated March 01, 2024 of the Ministry
of Health)
The criteria and rules for assessment
of ASEAN's common submission dossier templates (CSDT) of IVD medical devices
are developed based on the following documents:
1. Instruction for compilation of a
product dossier - Prequalification of in vitro diagnostics programme (WHO,
2014).
2. ASEAN Medical Device Directive
(2015).
3. Decision No. 2426/QD-BYT dated
May 15, 2021 of the Minister of Health on promulgation of guidance on the
preparation of ASEAN’s common submission dossier templates for medical devices.
4. Decision No. 3435/QD-BYT dated
December 21, 2022 of the Ministry of Health on the issuance of guidelines for
the evaluation and post-inspection of technical and clinical documentation in
applications for IVD medical device marketing registration.
5. REGULATION (EU) 2017/746 of the
European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and Commission Decision
2010/227/EU.
Experts may refer to additional
documents to assist in the evaluation of applications pertaining to cases that
have specific guidelines for each type of IVD medical device from WHO, GHTF,
ASEAN, etc.