Medical devices regulation

All medical devices marketed in Viet Nam must be announced or registered before distribution.

Announcement/registration is managed and approved by the National Institute of Medical Device and Construction under the Ministry of Health. ThienThao's pharmacist and lawyer teams are always available to offer you with a fast and effective registration service of medical devices announcement/ Certificate of Free Sales.

According to the Decree No. 36/2016/ND-CP issued on 15 May 2016 on medical devices management and the Circular No. 39/2016/TT-BYT of the Ministry of Health dated 28 October 2016 on classification of medical devices, medical devices comprises of 2 groups, classified into 4 types by potential risk levels related to its engineering design and production:

Group 1, including medical device category A as devices with low risk level.

Group 2, including medical device categories B, C and D with risk levels of low average, high average and high, respectively.

2. Registration sequences and procedures of Medical Devices Certificate of Free Sales

Do not hesitate to contact us for specific and accurate consultancy services to ensure that the registration is quickly and effectively initiated.

ThienThao is always available to offer you with a fast and effective registration service. Any regulation-related questions should be directed to us for the best advice on regulations and procedures.