Nghị định 03/2020/NĐ-CP sửa đổi Điều 68 Nghị định 36/2016/NĐ-CP về quản lý trang thiết bị y tế đã được sửa đổi tại Nghị định 169/2018/NĐ-CP sửa đổi Nghị định 36/2016/NĐ-CP về quản lý trang thiết bị y tế

DECREE

AMENDING ARTICLE 68 OF GOVERNMENT’S DECREE NO. 36/2016/ND-CP DATED MAY 15, 2016 ON MEDICAL DEVICE MANAGEMENT AMENDED BY GOVERNMENT’S DECREE NO. 169/2018/ND-CP DATED DECEMBER 31, 2018

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

At the request of the Minister of Health;

The Government hereby promulgates a Decree amending Article 68 of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on medical device management amended by the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018.

Article 1. Amendment to Clauses 5, 6 and 11 Article 68 of Decree No. 36/2016/ND-CP amended by Decree No. 169/2018/ND-CP

1. Clause 5 is amended as follows:

“a) The licenses to import class B, C and D medical devices and licenses to import in vitro diagnostic reagents issued in 2018, 2019, 2020 and 2021 will expire after December 31, 2021 and be exempt from any import quantity limit imposed by customs authorities; except for the cases specified in Clause 1 Article 42 and Point d of this Clause.

Traders of medical devices shall ensure that the documents prescribed in Point i Clause 2 Article 66 of this Decree are effective throughout the effective period of the import license. If any of the aforementioned documents expires, the trader shall inform the Ministry of Health, which will subsequently revoke the import license.

b) For class A medical devices of the Ministry of Health that already have the certificate of declaration of applied standards issued by a Department of Health, they may be imported without limits,  medical device classification forms and documents certifying that they belong to the Ministry of Health;

Medical devices that do not require the import license and have been classified as B, C or D by a classifying organization posted on the website of the Ministry of Health may be imported until the end of December 31, 2021 without limits and documents certifying that they belong to the Ministry of Health.

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

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

Applications for the license to import in vitro diagnostic reagents that are submitted during the period from January 01, 2019 to December 31, 2021 inclusive shall be approved in accordance with the 2005 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. Their registration numbers take effect from the date of issuance.

d) Certificates of registration of insecticides and germicides whose sole purpose is sterilization of medical devices which expire after July 01, 2016 and before December 31, 2020 will be effective until the end of December 31, 2020;

Applications for registration of insecticides and germicides whose sole purpose is sterilization of medical devices may be submitted from January 01, 2019. Registration numbers shall come into effect from the date of issuance.

dd) Registration numbers of domestically manufactured medical devices are effective until the expiration date written on the certificate of registration. The certificates of registration that expire after July 01, 2016 and before December 31, 2020 will be effective until the end of December 31, 2020.”

2. Clause 6 is amended as follows:

“6. Declarations of applied standards of class A medical devices may be submitted from January 01, 2017; certificates of declaration of applied standards shall come into effect from July 01, 2017; applications for registration of class B, C and D medical devices may be submitted from July 01, 2017; and 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. Clause 11 is amended as follows:

“11. The ASEAN Common Submission Dossier Template (CSDT) may be applied from January 01, 2022, from which date 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 from the date on which it is signed.

2. Clauses 5, 6 and 11 Article 68 of the Decree No. 36/2016/ND-CP amended by the Decree No.169/2018/ND-CP are annulled from the effective date of this Decree.

Article 3. Implementing responsibilities

Ministers, heads of ministerial-level agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities shall implement this Decree./.

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