Nghị định 03/2020/NĐ-CP sửa đổi Nghị định 36/2016/NĐ-CP quản lý trang thiết bị y tế

DECREE

On amending and supplementing Article 68 of the Decree No. 36/2016/ND-CP dated May 25, 2016 of Government on medical devices management which is amended and supplemented in the Decree No. 169/2018/ND-CP dated December 31, 20128 of the Government on amending and supplementing the Government’s Decree No. 36/2016/ND-CP on medical devices management

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Pursuant to the Law on Government Organization dated June 19, 2015;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree on amending and supplementing Article 68 of the Decree No. 36/2016/ND-CP dated May 25, 2016 of Government on medical devices management which is amended and supplemented in the Decree No. 169/2018/ND-CP dated December 31, 20128 of the Government on amending and supplementing the Government’s Decree No. 36/2016/ND-CP on medical devices management

Article 1. To amend and supplement Clause 5, 6, 11 Article 68 of the Decree No. 36/2016/ND-CP dated May 25, 2016 of Government on medical devices management which is amended and supplemented in the Decree No. 169/2018/ND-CP as follow:

1. a) To amend Clause 5 as follows:

“a) The licenses to import class B, C D medical devices and the licenses to import in vitro diagnostic reagents issued in 2018, 2019, are effective until the end of December 31, 2019, 2020, and 2021 shall be valid until December 31, 2021 and the customs agencies shall not impose any limits on import quantity in these cases except for the case prescribed in Clause 1 Article 4 and point d this Clause.

Traders of medical devices shall ensure that the documents specified in Point I Clause 2 Article 66 of this Decree are effective throughout the effective period of the import license. In case where the validity of the above documents is no longer maintained, the trader shall hold responsibility to inform the Ministry of Health to implement the subsequently revocation of the import license as prescribed by laws.

b) Class A medical devices of the Ministry of Health that already have the certification of declaration of applied standards issued by a Department of Health may be imported without limitation on quantity and classification document and written certification of medical equipment of the Ministry of Health when carrying out customs clearance procedures;

Medical devices that not on the list of goods subject to import licensing and have been classified as class B, C or D by a classifying organization and posted on the website of the Ministry of Health shall be allowed to be imported until the end of December 31, 2021 without limits and without the confirmation that they belong to the Ministry of Health when carrying out customs clearance procedures.

c) Registration numbers of medical devices that are in vitro diagnostic reagents and granted the certificate of registration in accordance with the Law on Pharmacy of 2005 and its instructional documents will be effective until the expiration date on their certificate of registration. Especially for the registration numbers of in vitro diagnostic reagents issued that expire after January 01, 2019 and before December 31, 2021, such registration numbers will be effective until the end of December 31, 2021;

Medical devices that are in vitro diagnostic reagents of which applications for registration are submitted before January 01, 2019 in accordance with the Law on Pharmacy of 2005 shall be processed in accordance with the Law on Pharmacy of 2005;

Applications for the license to import in vitro diagnostic reagents that are submitted during the period from January 01, 2019 to December 31, 2021 shall be granted in accordance with the 2005’s Law on Pharmacy; such import licenses shall be effective until the end of December 31, 2021;

Applications for registration of domestically manufactured medical devices can be submitted from January 01, 2019. Registration number shall take effect on the issuing date.

d) Certificates of registration of insecticides and germicides for the sole purpose of sterilization for medical devices which expires after July 01, 2016 and before December 31, 2020 will be continue its effectiveness until the end of December 31, 2020;

Applications for registration of insecticides and germicides for the sole purpose of sterilization of medical devices may be submitted from January 01, 2019. Registration number shall take effect on the issuing date.

dd) Registration numbers of domestically manufactured medical devices are effective until the expiration date written on the certificate of registration. Especially for the certification of registration that expire after July 01, 2016 and before December 31, 2020, such certification of registration shall continue to be effective until the end of December 31, 2021.”

2. To amend Clause 6 as follows:

“6. Declarations of applied standards of Class A medical devices may be submitted from January 01, 2017; certifications of declaration of applied standards shall come into effect from July 01, 2017; applications for registration of Class B, C, D medical devices may be submitted from July 01, 2017; registration numbers of medical devices shall come into effect from January 01, 2022, except for the cases specified in Point c and Point d Clause 5 of this Article.”

3. To amend Clause 11 as follows:

“11. The common technical dossier of ASEAN (CSDT) shall be applied from January 01, 2022. From January 01, 2022, applicants for registration are not required to provide the documents mentioned in Point g, Point i and Point m Clause 1 Article 26 of this Decree.”

Article 2. Effect

1. This Decree takes effect on the signing date.

2. Clause 5, 6, 11 of the Decree No. 36/2016/ND-CP which is amended and supplemented by the Decree No. 169/2018 shall null and void since the effective date of this Decree.

Article 3. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of Government affiliated agencies, Chairperson of provincial and municipal cities’ People's Committee shall take responsibility to implement this Decree./.

For the Government

The Prime Minister

Nguyen Xuan Phuc