Decree No. 03/2020/ND-CP amends and supplements Article 68 of Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on medical equipment management, which has been amended and supplemented by Decree No. 169/2018/ND-CP dated December 31, 2018, of the Government amending and supplementing some articles of Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on medical equipment management.

DECREE

Amending and supplementing Article 68 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management which has been amended and supplemented
by Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing some articles of Decree No. 36/2016/NĐ-CP
dated May 15, 2016 of the Government on medical equipment management
On the basis of the Law on Government Organization dated June 19, 2015;
The Government promulgates this Decree to amend and supplement Article 68 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management which has been amended and supplemented by Decree No.

169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing some articles of Decree No.36/2016/NĐ-CP dated May 15, 2016 of the Government on medical equipment management.

At the proposal of the Minister of Health;

the Government detailing certain provisionsArticle 1. Amending and supplementing Clauses 5, 6, 11 of Article 68 of Decree No. 36/2016/NĐ-CP which has been amended and supplemented by Decree No. 169/2018/NĐ-CP as follows: 1. Clause 5 is amended as follows:"a) Import permits for medical equipment categories B, C, D and import permits for in vitro diagnostic reagents issued in 2018, 2019, 2020, 2021 shall remain valid until December 31, 2021, and customs authorities shall not control the quantity of imports in these cases, except as provided in Clause 1, Article 42 and point d of this clause. Organizations and individuals engaged in the business of medical equipment shall be responsible for ensuring that the documents specified in point i, Clause 2, Article 66 of this Decree remain valid during the period the import permit remains valid. In case they cease to maintain the validity of such documents, organizations and individuals engaged in the business of medical equipment must notify the Ministry of Health to revoke the issued import permit according to regulations. b) For medical equipment category A that has received a standard application acceptance certificate from the Department of Health, it can be imported based on demand without limitation on quantity and without the need for classification documents and confirmation letters from the Ministry of Health when performing clearance procedures;

For medical equipment not included in the list requiring import permits but already classified as categories B, C, D by organizations recognized by the Ministry of Health and published on the electronic portal, they may continue to be imported until December 31, 2021 based on demand without limitation on quantity and without the need for confirmation letters from the Ministry of Health when performing clearance procedures.

c) In vitro diagnostic reagents that have been granted registration certificates under the Drug Law 2005 and its implementing regulations shall have their registration numbers valid for use until the expiration date stated on the registration certificate. Specifically, for registration numbers of in vitro diagnostic reagents that expire after January 1, 2019 and before December 31, 2021, the registration numbers shall remain valid for use until December 31, 2021;

In vitro diagnostic reagents that submitted registration applications under the Drug Law 2005 before January 1, 2019 shall be processed according to the Drug Law 2005;

In vitro diagnostic reagents imported and submitted registration applications between January 1, 2019 and December 31, 2021 shall be granted import permits according to the Drug Law 2005 and shall remain valid until December 31, 2021;

Registration number applications for domestic production of medical equipment will start being accepted from January 1, 2019. The registration numbers will become effective from the date of issuance.

d) Chemicals and insecticides, bactericides used solely for disinfecting medical equipment that have been granted circulation certificates expiring after July 1, 2016 and before December 31, 2020 may continue to use those circulation certificates until December 31, 2020;

Applications for registration numbers for chemicals and insecticides, bactericides used solely for disinfecting medical equipment will start being accepted from January 1, 2019. The registration numbers will become effective from the date of issuance.

đ) Domestic-produced medical equipment that has been granted registration certificates for circulation shall have their circulation numbers valid for use until the expiration date stated on the registration certificate. Specifically, for registration certificates expiring after July 1, 2016 and before December 31, 2020, the registration certificates may continue to be used until December 31, 2020."

2. Clause 6 is amended as follows:

"6. Applications for standard application declarations for medical equipment category A will start being accepted from January 1, 2017, and the acceptance certificates for standard application declarations will become effective from July 1, 2017; applications for registration numbers for medical equipment categories B, C, D will start being accepted from July 1, 2017, and the registration numbers for medical equipment will become effective from January 1, 2022, except as provided in points c and d of Clause 5 of this Article."

3. Clause 11 is amended as follows:

"11. The ASEAN Common Technical Documentation (CSDT) will be implemented starting from January 1, 2022. Starting from January 1, 2022, entities applying for registration numbers will not need to provide the documents specified in point g, i, m of Clause 1, Article 26 of this Decree."

2. Clauses 5, 6, 11 of Article 68 of Decree No. 36/2016/NĐ-CP amended and supplemented by Decree No. 169/2018/NĐ-CP shall cease to be effective from the date this Decree takes effect.

2. Clause 6 is amended as follows:

"6. Commence accepting applications for the publication of standards applicable to medical devices of type A from January 1, 2017, and the acceptance receipt for the application for the publication of standards shall be effective from July 1, 2017; commence accepting registration applications for the circulation of medical devices of types B, C, and D from July 1, 2017, and the circulation number of medical devices shall be effective from January 1, 2022, except in cases provided for in points c and d of Clause 5 of this Article."

3. Clause 11 is amended as follows:

"11. The Common Standard Declaration Form (ASEAN CSDT) shall be implemented from January 1, 2022. From January 1, 2022, entities applying for circulation numbers are not required to provide the documents specified in point g, i, and m of Clause 1 of Article 26 of this Decree."

Article 2. Effective Date

1. This Decree takes effect from the date of issuance.

2. Clauses 5, 6, and 11 of Article 68 of Decree No. 36/2016/NĐ-CP, amended and supplemented by Decree No. 169/2018/NĐ-CP, shall cease to be effective from the date this Decree takes effect.

Article 3. Responsibility for Implementation

Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial and centrally-administered city People's Committees are responsible for implementing this Decree./.