NEW REGULATIONS ON THE MANAGEMENT OF MEDICAL DEVICES

On August 1, 2022, the Ministry of Health issued Circular 05/2022/TT-BYT (“Circular 05”) stipulating the implementation of a number of articles of Decree No. 98/2021/ND-CP (“Decree 98”) dated November 8, 2021 of the Government on the management of medical devices. Circular 05 had some notable points as follows:

Supplementation of medical devices to be traded as normal goods:

1. Blood oxygen saturation (SpO2) meter using battery finger clip.
2. In vitro diagnostic medical device for self-testing for HIV, SARS-CoV-2.
3. Nasal aspirator for children.

Supplementation of a list of in vitro diagnostic medical devices that are not required quality evaluation:

1. Medical devices being granted a certificate of free sale of one of the countries, organizations according to regulations, such as FDA – USA, EU, TGA – Australia, Health – Canada, PMDA – Japan, etc.
2. Medical devices being granted a registration number or a Market Authorization, an import license in the commercial form in Vietnam, except for cases where it is revoked.
3. Not a type of reagent, calibrator, or in vitro control material.

Clarification of classification rules of medical devices based on risk level

The Circular integrated rules for classification of medical devices replacing Circular 39/2016/TT-BYT dated October 28, 2016 of the Ministry of Health.

This Circular became effective from 1/8/2022.