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THE GOVERNMENT
OF VIETNAM
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THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No.: 07/2023/ND-CP
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Hanoi, March 03,
2023
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DECREE
AMENDMENTS TO
GOVERNMENT’S DECREE NO. 98/2021/ND-CP DATED NOVEMBER 08, 2021 PRESCRIBING
MEDICAL DEVICE MANAGEMENT
Pursuant to the Law on Government Organization
dated June 19, 2015; the Law on Amendments to the Law on Government
Organization and the Law on Local Government Organization dated November 22,
2019;
At the request of the Minister of Health of
Vietnam;
The Government promulgates a Decree providing
amendments to the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021
prescribing medical device management.
Article 1. Amendments to Government’s Decree No.
98/2021/ND-CP dated November 08, 2021 prescribing medical device management
1. Clause
2 Article 21 is amended as follows:
“2. Registration number holder is the
organization that declares applied standards for medical devices or is issued
with the certificate of registration of medical devices in accordance with the
provisions of this Decree.”.
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“Article 22. Conditions for placement of
medical devices on the market
1. A medical device may be placed on the market if
it meets the following conditions:
a) It has been granted registration number,
marketing authorization number, certificate of registration or import license
in accordance with regulations on management of medical devices or in the cases
specified in Point d Clause 2 Article 76 of this Decree, except the following
cases:
- The medical device is liquidated as prescribed by
laws;
- The medical device reaches its expiry date;
- The defect that is harmful to users’ health
cannot be repaired as prescribed in Clause 4 Article 34 of this Decree;
- The use of medical device is prohibited by a
regulatory authority.
b) Its label contains adequate information in
accordance with regulations of law on labeling of goods;
c) Instructions for use of the medical device are
given in Vietnamese language;
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2. If the import license is available as prescribed
in Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the
satisfaction of the condition in Point d Clause 1 of this Article is not
required.
3. If the information specified in Point c and
Point d Clause 1 of this Article is not provided upon the medical device
itself, it must be provided in the form of electronic information for which
instructions for search must be available on the label of the medical device.”
3. Point
c Clause 3 Article 32 is amended as follows:
“c) The applying organization shall comply
with the request for modification and send modified documents to the Ministry
of Health as requested.
If the modified application is still
unsatisfactory, the Ministry of Health shall continue sending a request for
modification to the applying organization as prescribed in Point b Clause 3 of
this Article.
If the applying organization fails to provide the
modified application within 90 days from the receipt of the Ministry of
Health’s request for modification or the application is still unsatisfactory
after 03 modification times, the application shall be rejected.”.
4. Clause
6 Article 37 is amended as follows:
“6. If the Ministry of Health has given a
written response indicating its refusal to permit the placement of the medical
device on the market as prescribed in Clause 5 of this Article, the
registration number holder or distributor shall conduct the recall of medical
devices placed on the market, except those sold to health facilities or users.”.
5. Heading
of Section 5 Chapter V is amended as follows:
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6. Clause
14 is added to Article 38 as follows:
“14. A document included in the application
for registration of medical device is found by a competent authority to be
unconformable with regulations of law.”.
7. Clause
6 is added to Article 39 as follows:
“6. Within 05 working days from the receipt
of the written conclusion from a competent authority as prescribed in Clause 14
Article 38 of this Decree, the registration number issuing authority shall
consider issuing a document on revocation of registration number under its
jurisdiction.
Upon receipt of the document on revocation of
registration number, relevant competent authorities shall follow the procedures
in Clauses 3 and 4 of this Article.”.
8. Article
39a is added as follows:
“Article 39a. Disposal of medical
devices of which registration number is revoked
1. Medical devices which have been sold to health
facilities or users shall still be used until they are liquidated as prescribed
by law or they reach their expiry date, except medical devices containing
defects which are harmful to user’s health but cannot be repaired as prescribed
in Clause 4 Article 34 of this Decree.
2. Where a medical device of which registration
number is revoked is not yet sold to users or health facilities, the
registration number holder shall suspend the placement of that medical device
on the market and implement measures for recalling it.".
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“Article 44. Posting prices of medical
devices
1. Manufacturers and traders of medical devices
shall post prices of medical devices at the locations prescribed in Article 17
of the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013 or on the
web portal of the Ministry of Health of Vietnam.
2. The following information must be provided when
posting prices of medical devices on the web portal of the Ministry of Health
of Vietnam:
a) Name and category of the medical device;
b) Manufacturer and manufacturing country; product
owner and country of product owner;
c) Unit;
d) Configurations, technical functions of the
medical device;
dd) Price of medical device.”.
10. Article
45 is amended as follows:
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1. Manufacturers and traders of medical devices
shall declare prices of their medical devices; contents and procedures for
declaring prices of medical devices shall comply with regulations of law on
pricing.
2. Based on actual situations and upon the
occurrence of considerable changes in prices which affect the supply of medical
devices, payment capacity of buyers and the health insurance fund, the Minister
of Health of Vietnam shall promulgate, update and revise the list of medical
devices subject to compulsory price declaration and guidelines thereon.
3. Prices of medical devices shall be declared in
the forms specified in the law on pricing or on the web portal of the Ministry
of Health of Vietnam.”.
11. Article
46 is amended as follows:
“Article 46. Rules for management of
import and export of medical devices
1. Importers and exporters of medical devices must
satisfy eligibility requirements laid down in the law on import and export and
assume responsibility to ensure quality, quantities, categories and intended
purposes of their imported/exported medical devices.
2. Medical devices that have been granted
registration numbers in Vietnam may be exported and imported without limits on
quantities and are exempt from approval of the Ministry of Health of Vietnam.
3. The import license is required for the medical
devices specified in Clause 1 Article 48 of this Decree which are imported for
use in Vietnam.
4. The transport of medical devices other than
those specified in Clause 2 and Clause 3 of this Article into Vietnam in other
forms shall comply with regulations of the law on foreign trade management.
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6. Import of used medical devices shall comply with
regulations of the law on foreign trade management.”.
12. Article
48 is amended as follows:
a) Point e Clause 1 Article 48 is amended as
follows:
e) Unregistered medical devices are imported for
use in health facilities with ODA funding and concessional loans or grants
other than ODA grants.”.
b) Point o is added to Clause 2 Article 48 as
follows:
“o) In the case specified in Point e Clause 1
of this Article, the application for import license shall include:
- The original copies or certified true copies of
the decision to approve the investment guidelines and the investment decision
for an investment project or the decision to approve project documents for a
project on technical assistance, project costs or grants other than ODA grants,
in which the import of medical devices must be indicated;
- The original copy of certified true copy of the
contract for supply of medical devices for the project;
- The power of attorney granted by the product
owner to the applicant which must be still valid at the date of application
submission. Either the document bearing consular legalization or the certified
true copy thereof is accepted;
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- The unexpired CFS (for imported medical devices).
Either the document bearing consular legalization or the certified true copy
thereof is accepted. If the CFS is made neither in English nor in Vietnamese,
it shall be translated into Vietnamese. The Vietnamese translation must be
certified as prescribed by law.”.
13. Clause
3 Article 52 is amended as follows:
“3. Post and declare prices of medical
devices in accordance with the provisions of this Decree and the law on
pricing.”.
14. Clause
12 is added to Article 66 as follows:
“12. If any document required for completing
procedures specified in this Decree must be treated as confidential, it shall
be submitted in person and managed in accordance with regulations on management
of confidential documents.”.
15. Article
70 is amended as follows:
a) Clause 5 Article 70 is amended as follows:
“5. Publish the following information on its
web portal:
a) Successful bids for procurement of medical
devices by state-owned health facilities nationwide;
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c) List of organizations/individuals forging
applications or committing violations against regulations on management of
medical devices set out in this Decree.”.
b) Clause 7 Article 70 is amended as follows:
“7. Play the leading role and cooperate with
regulatory authorities in conducting inspections, settling
complaints/denunciations and taking actions against violations related to
medical devices in accordance with regulations of this Decree and relevant
laws.”.
c) Clause 13 and Clause 14 are added to Article
70 as follows:
“13. Publish and revise the list of medical
devices subject to compulsory price declaration to meet management requirements
and actual situations.
14. Give guidelines for information on medical
devices subject to compulsory price declaration.”.
16. Clause
5 Article 73 is amended as follows:
“5. Take responsibility to organize and
process procedures as prescribed in this Decree; organize inspections, settle
complaints/denunciations and take actions against violations related to medical
devices and their prices in their provinces in accordance with regulations of law.”.
17. Article
74 is amended as follows:
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“o) Post and declare prices of medical
devices in accordance with the provisions of this Decree and the law on
pricing.”.
b) Clause 5 is added to Article 74 as follows:
“5. When submitting applications for handling
of procedures as prescribed in this Decree, the applying organizations or
individuals shall:
a) assume legal responsibility for the accuracy and
legitimacy of documents and materials included in their submitted applications;
b) ensure the consistency and conformity of
information on medical device provided in the initially submitted request or
application with that provided in documents additionally submitted at the
request of competent authorities;
c) ensure the validity of submitted documents
during the handling of procedures;
d) retain documents included in their submitted
applications.”.
18. Article
76 is amended as follows:
“Article 76. Transition
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a) With regard to an application for registration
of Class-B medical device, the Ministry of Health of Vietnam shall instruct the
applicant to review the submitted application and follow procedures for
declaration of applied standards in accordance with this Decree without paying
additional fee.
b) With regard to an application for registration
of Class-C or D medical device, the Ministry of Health of Vietnam shall issue
registration number according to Article 32 of this Decree if it meets all of
the requirements laid down in Clause 3 Article 30 of this Decree;
c) The classification result given by a
classification body eligible to classify medical devices before the effective
date of this Decree may be used.
2. Regulations on validity of import license;
import of medical devices which are not subject to import license requirements:
a) An import license for medical devices other than
IVD reagents which is issued within the period from January 01, 2018 to
December 31, 2021 shall remain valid until December 31, 2024 inclusively;
b) An import license for medical devices which are
IVD reagents which is issued within the period from January 01, 2018 to
December 31, 2021 shall remain valid until December 31, 2024 inclusively and
impose no limit on import quantities;
c) Holders of import license prescribed in Point a
and b of this Clause shall meet relevant eligibility requirements laid down in
laws and assume responsibility for quality, quantity, categories and uses of
their imported medical devices. The Ministry of Health of Vietnam shall carry
out inspections and consider revoking the import license in case of violations
against regulations on management of medical devices;
d) The import of medical devices which are not
subject to import license requirements (except insecticidal and germicidal
chemicals and preparations for medical and household use which are used for
disinfection of medical devices only) and have been classified as Class-C or D
medical devices as published on the web portal of the Ministry of Health of
Vietnam may continue until the end of December 31, 2024 without limits on
import quantities and requiring the Ministry of Health of Vietnam’s
confirmation as medical devices, regardless of the time of publishing
information on such medical devices on the web portal of the Ministry of Health
of Vietnam.
When following import procedures, the importer
shall declare the number of document indicating medical device classification
results given by itself or by a qualified classification body and shall assume
responsibility for quality, quantity, categories and uses of imported medical
devices.
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3. Regulations on validity of registration number,
certificate of registration of medical device, and marketing authorization
number:
a) Registration numbers issued according to the
Decree No. 36/2016/ND-CP before January 01, 2022 shall remain valid
indefinitely;
b) Certificates of registration of domestically
manufactured medical devices issued before January 01, 2022 shall remain valid
until the expiry dates thereon;
c) Marketing authorization numbers of medical
devices which are IVD reagents issued within the period from January 01, 2014
to December 31, 2019 shall remain valid until December 31, 2024 inclusively;
d) Marketing authorization number issued to medical
devices that are IVD reagents within the period from January 01, 2020 to
December 31, 2021 shall remain valid until the expiry dates on issued marketing
authorization certifications;
dd) Holders of certificate of registration or
marketing authorization number prescribed in Points b, c and d of this Clause
shall meet relevant eligibility requirements laid down in laws and assume responsibility
for quality, quantity, categories and uses of their imported medical devices.
The Ministry of Health of Vietnam shall carry out inspections and consider
revoking certificates of registration or marketing authorization numbers in
case of violations against regulations on management of medical devices.
4. Regarding applications for import license for
medical devices which have been submitted before January 01, 2022 but have not
been yet processed:
The Ministry of Health of Vietnam shall inform and
request applicants to complete their applications for registration number
according to the provisions of the Decree No. 98/2021/ND-CP and prioritize the
processing of such applications. If the applicant wants to obtain an import
license according to the submitted application, the Ministry of Health of
Vietnam shall issue the import license according to the sequence and procedures
in Point c of this Clause if the submitted application is adequate and meets
the requirements laid down in Point a or b of this Clause.
a) An application for import license for a medical
device included in the list of medical devices subject to import license
requirements published by the Minister of Health of Vietnam shall include:
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- The unexpired CFS of the category of medical
device to be imported (original copy or certified true copy);
- The manufacturer’s unexpired certificate of
conformity with ISO 13485 quality control standards (the original or copy
bearing the applicant’s certification);
- Technical file describing the category of
imported medical device in Vietnamese (bearing the applicant’s certification);
- Catalogue describing functions and technical
specifications of category of imported medical device;
- Documents on clinical evaluation and instructions
for use of the product owner or manufacturer of medical devices which are
invasive devices and instruments in cardiology and cranial nerve.
b) An application for import license for IVD
reagents shall include:
- Import order;
- The unexpired CFS (original copy or certified
true copy);
- The manufacturer’s unexpired certificate of
conformity with ISO 13485 quality control standards (the original or copy
bearing the applicant’s certification);
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- Label and user manual in Vietnamese accompanied
with original label and user manual (bearing the applicant’s certification).
c) Procedures for granting import license:
- If the application for import license does not
need to be modified, the Ministry of Health of Vietnam shall issue the import
license. If the application for import license is refused, a written response
indicating reasons for refusal shall be given;
- If the application for import license needs to be
modified, the Ministry of Health of Vietnam shall send a request to the
applicant for modification, in which documents and/or contents to be modified
must be indicated;
- Upon receipt of the request for modification, the
applicant shall provide the modified application to the Ministry of Health of
Vietnam within 60 days from the date of the request and shall also assume
responsibility for the consistency of contents of the modified application and
those of the previously submitted application.
Over 60 days from the receipt of the request for modification
from the Ministry of Health of Vietnam, if the applicant fails to submit the
modified application or the application is still unsatisfactory after 03
modification times, the Ministry of Health of Vietnam shall refuse to issue the
import license;
d) An import license issued according to the
provisions of this Clause shall be valid until December 31, 2024, inclusively.
5. Regulations on application of ASEAN Common
Submission Dossier Template (CSDT): CSDT is compulsory from January 01, 2024.
6. Applications for issuance of registration number
submitted before January 01, 2024 as prescribed in Article 30 of this Decree:
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- The synopsis of technical description of the
medical device: the copy in Vietnamese accompanied by technical documents
describing functions and specifications of the medical device issued by the
product owner and bearing the applicant’s certification shall be submitted. For
in-vitro reagents, calibrators and control materials: the synopsis of technical
description in Vietnamese must be accompanied by documents stating materials
and safety of the product, manufacturing process, pre-clinical and clinical
study reports including stability reports;
- The user manual for medical device: the copy in
Vietnamese bearing the applicant’s certification, accompanied by the original
copy in English issued by the product owner in case of imported medical device;
- Sample of the label for the medical device sold
in Vietnam: The sample label bearing the applicant’s certification is
submitted. The sample label must meet requirements laid down in regulations of
law on labeling of goods.
b) The receipt and processing of applications for
registration of medical devices prescribed in Clauses 1, 2, 3 and 4 Article 30
of this Decree shall comply with the provisions of Article 32 of this Decree.
c) An application for registration of a medical
device prescribed in Clause 5 Article 30 of this Decree shall be received and
processed as follows:
- If the application does not need to be modified,
the Minister of Health of Vietnam shall process the application and consider
issuing the registration number within 90 days from the receipt of the adequate
and valid application (including application fee receipt as prescribed by the
Ministry of Finance). If the application is refused, a written response
indicating reasons for refusal shall be provided;
- If the application needs to be modified, the
Ministry of Health of Vietnam shall send a request for modification, in which
such documents and contents requiring modification must be specified, to the
applicant that is required to send the modified application to the Ministry of
Health of Vietnam within 60 days from the receipt of the request;
- The applicant shall comply with the request for
modification and send the modified application to the Ministry of Health.
If the modified application is still
unsatisfactory, the Ministry of Health of Vietnam shall continue sending a
request for modification to the applicant to modify the application as prescribed
in this Clause.
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7. The application of the following regulation:
“Prohibition of trading in medical devices before their prices are declared or
at prices higher than those available on the Ministry of Health’s web portal at
the time of trading” is optional with respect to contract packages for bid
opening is made before April 01, 2022.
8. Regarding contract packages for purchase of
medical devices for which the supplier selection plans have been approved
before the effective date of this Decree but bidding documents have yet to be
published or issued, the modification of supplier selection plans in respect of
price-related contents shall comply with regulations of law on bidding if it is
deemed necessary.”.
Article 2. Implementation
This Decree comes into force from the date on which
it is signed.
Article 3. Responsibility for implementation
1. The Minister of Health of Vietnam shall
instruct, organize and inspect the implementation of this Decree.
2. Ministers, heads of ministerial agencies, heads
of Governmental agencies, Chairpersons of Provincial People’s Committees and
relevant authorities, organizations and individuals are responsible for the
implementation of this Decree./.
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