blue-check New regulations on medical device management from 2022

Decree No. 98/2021/ND-CP dated November 8th, 2021 of the Government on prescribing medical device management
Posted: 10/11/2021 12:48:29 PM | Latest updated: 18/12/2021 10:06:02 AM (GMT+7) | LuatVietnam: 5331 | Vietlaw: 538

One of the major changes of this Decree is the addition of medical devices into groups of goods subject to price declaration. Accordingly, prices of medical devices shall be declared and posted on the Ministry of Health’s Portal before they are placed on the market with all information according to the regulations at Article 45.

However, this Decree loosens many conditions on manufacturing, trading in medical devices, such as:

- Removing the limit on validity duration of registration number of medical devices. Under the earlier regulations, the maximum validity duration of registration number is 5 years.

- Class-B medical device shall be transferred to the form of “self-declaration of applied standards” similar to Class-A medical device rather than having to apply for permission for circulation

- With regard to Class-C or Class-D medical devices, quick issuance of a new registration number shall be implemented on the basis of recognition of Certificate of Free Sale granted by foreign country.

- Owner of medical devices may themselves classify medical devices and take responsibility for the classification result. The classification of medical devices is not required to perform at eligible facilities as prescribed in the earlier regulations.

- Removing procedures for certification of contents of an advertisement for a medical device, replaced by the form according to which enterprises shall publish on the Portal on management of medical devices planned contents and form of advertising.

This Decree takes effect from January 1st, 2022.

To replace Decree No. 36/2016/ND-CPstatus1 dated May 15th, 2016, Decree No. 169/2018/ND-CPstatus1 dated December 31st, 2018, Decree No. 03/2020/ND-CPstatus1 dated January 1st, 2020

To replace Article 7 of Decree No. 181/2013/ND-CPstatus2 dated November 14th, 2013.

Related documents
blue-check 1672/BYT-TB-CTFrom January 1st, 2022: It is required to disclose prices of medical devices on the Ministry of Health’s website
blue-check 5652/QĐ-BYT
blue-check 19/2021/TT-BYT
Penalty document
Effective Date 1-Jan-2022
ExpiredDate Unknown
Published Vietlaw's Newsletter No. 538
Files attachment
enflag pdficon ND98-08112021CP[EN].pdf