Chapter XIII
IMPLEMENTATION
Article 75. Effect
1. This Decree comes into force from January 01, 2022.
2. The following Decrees cease to have effect from the effective date of this Decree, including:
a) Government’s Decree No. 36/2016/ND-CP dated May 15, 2016;
b) Government’s Decree No. 169/2018/ND-CP dated December 31, 2018;
c) Government’s Decree No. 03/2020/ND-CP dated January 01, 2020.
3. Article 7 of the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013 shall be abrogated from July 01, 2022.
Article 76. Transition
1. The medical devices which have been manufactured in Vietnam or imported into Vietnam before the effective date of this Decree shall continue to be placed on the market until they are liquidated in accordance with regulations of law on management and use of public assets or the expiry date specified on the certificate of registration or expiry date of the product.
2. Regulations on validity of the registration number or import license issued before January 01, 2022:
a) Registration numbers of medical devices which have been issued in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016, as amended in Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP (hereinafter referred to as “Decree No. 36/2016/ND-CP”) shall be valid for indefinite term;
b) If domestically manufactured medical devices have been issued certificates of registration, these certificates of registration shall be valid until the expiry dates thereon;
c) Import licenses issued to medical devices other than IVD reagents on January 01, 2018 onwards shall be valid until December 31, 2022 inclusively;
d) 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) and have been classified as Class-C or D medical devices as published on the Ministry of Health’s Portal may continue to be imported until December 31, 2022 without limits on quantities and confirmation as medical devices from the Ministry of Health;
dd) Medical devices that are IVD reagents and have been granted registration number within the period from January 01, 2014 to December 31, 2017, these registration numbers shall be valid until December 31, 2022;
e) Medical devices that are IVD reagents and have been granted registration number within the period on January 01, 2018 onwards, these registration numbers shall be valid until the expiry dates thereon;
g) Import licenses issued to medical devices that are IVD reagents on January 01, 2018 onwards shall be valid until December 31, 2022 inclusively without limits on quantities. Customs authorities shall not control import quantities in this case.
3. Applications for registration number which are submitted in accordance with the Decree No. 36/2016/ND-CP before January 01, 2022 but have been not yet processed before the effective date of this Decree shall be processed as follows:
a) With regard to an application for registration of Class-B medical device, the Ministry of Health shall instruct the applicant to review the application and follow procedures for declaration of applied standards in accordance with this Decree without paying application fee.
b) With regard to an application for registration of Class-C or D medical device, the Ministry of Health shall issue registration number according to Article 32 of this Decree if it meets the requirements laid down in Clause 3 Article 30 of this Decree;
c) Classification result given by the classification body that has been granted certification of declaration of eligibility to classify medical devices before the effective date of this Decree may be used.
4. Applications for license to import medical devices submitted before January 01, 2022 shall be processed in accordance with legislative documents promulgated by the Minister of Health before the effective date of this Decree. An import license issued according to the provisions of this Clause shall be valid until December 31, 2022.
5. Labels of medical devices which have been manufactured in Vietnam or imported into Vietnam before the dates specified in Clause 2 and Clause 4 of this Article shall continue to be used until the expiry date of medical device or the medical device is liquidated in accordance with regulations of law on management and use of public assets or until the expiry date specified on the certificate of registration or expiry date of the product.
6. Regulations on application of CSDT:
a) CSDT is compulsory from January 01, 2023.
b) With regard to applications for issuance of registration number submitted before December 31, 2022, an application shall consist of the documents specified in Points a, b, d, dd Clause 1 Article 30 of this Decree and the following documents:
- A synopsis of technical description of the medical device in Vietnamese, accompanied by technical documents describing functions and specifications of the medical device issued by the product owner.
With regard to in-vitro reagents, calibrators and control materials, the synopsis of technical description in Vietnamese must be accompanied by documents on materials and safety of the product, manufacturing process, pre-clinical and clinical study reports including stability report.
- User manual of the medical device.
- Sample of the label for the medical device sold in Vietnam.
Such documents must meet the following requirements:
- Technical documents of the medical device: copy bearing the applicant’s certification.
- User manual of the medical device: 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 label: the sample label bearing the applicant’s certification. The sample label must meet requirements laid down in regulations of law on labeling of goods.
c) An application for registration of a medical device prescribed in Point b of this Clause shall be received and processed as follows:
- If the application is satisfactory, the Minister of Health shall 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 an application is refused, reasons for such refusal must be given in writing.
- If the application is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 70 days from the receipt of the application;
- The applicant 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 applicant as prescribed in Point b Clause 6 of this Article.
If the applicant 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 05 modification times, the application shall be rejected.
7. Declaration of contents and form of advertising of medical devices shall be applied from July 01, 2022.
8. Holders of registration numbers or licenses to import medical devices issued before the effective date of this Decree are required to comply with the provisions of Clause 4 Article 45 of this Decree before April 01, 2022 for their medical devices placed on the market of Vietnam and before placing their imported medical devices on the market of Vietnam.
Article 77. Responsibility for guidance and implementation
1. The Minister of Health 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.
Tìm kiếm
Nghị định 98/2021/NĐ-CP (Bản Word)
Nghị định 98/2021/NĐ-CP (Bản Pdf)