Circular 05/2022/TT-BYT detailing Decree 98/2021/ND-CP on management of medical devices

CIRCULAR

Detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices

Pursuant to the Government’s Decree No 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices;

At the request of the Director of the Department of Medical Equipment and Construction;

The Minister of Health promulgates the Circular detailing a number of articles of the Government’s Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

Article 1. Scope of regulation

1. This Circular details a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices (hereinafter referred to as Decree No. 98/2021/ND-CP), including:

a) Classification of medical devices prescribed in Clause 5, Article 5 of Decree No. 98/2021/ND-CP;

b) The supplement of the list of in vitro diagnostic medical devices that is not subject to quality assessment by any competent agencies of Vietnam prescribed at Point dd, Clause 3, Article 30 of Decree No. 98/2021/ND-CP;

c) The list of medical devices of types B, C, D that can be traded like other normal goods prescribed in Clause 1, Article 42 of Decree No. 98/2021/ND-CP;

d) The list of medical devices subject to safe and technical inspection prescribed in Clause 10, Article 70 of Decree No. 98/2021/ND-CP;

dd) The list of medical devices being granted import licenses as prescribed at Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP.

2. Announcing the invalidity of a number of legal documents on the management of medical devices.