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August 9, 2022

Vietnam Issues New Guidance on Medical Device Regulations

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In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. 98/2021/ND-CP dated November 8, 2021), which came into force on January 1, 2022. This is the primary legislation on medical devices in Vietnam. To provide necessary guidance and elaboration on the implementation of Decree 98, the Ministry of Health recently issued Circular No. 05/2022/TT/BYT dated August 1, 2022 (“Circular 05”), which took effect on the same day.

The most notable aspect of Circular 05 is that it unifies, in a single legislative document, previous regulations on medical devices that were scattered in multiple circulars issued by the Ministry of Health (Circular No. 39/2016/TT-BYT dated October 28, 2106; Circular No. 46/2017/TT-BYT dated December 15, 2017, as amended by Circular No. 23/2021/TT-BYT dated December 9, 2021; and Circular No. 33/2020/TT-BYT dated December 31, 2020). The effectiveness of these circulars was terminated when Circular 05 took effect.

Circular 05 sets out regulations and principles for the classification of medical devices, and adds or supplements the following lists:

  1. List of in vitro diagnostic medical devices (IVD) not subject to quality assessment by Vietnamese competent authorities when registering under the quick registration procedure.
  2. List of class B, C and D medical devices allowed to be traded as normal goods.
  3. List of medical devices required to be accredited for safety and technical functions before use.
  4. List of medical devices requiring import permit licenses.

While Circular 05 does not introduce major changes to the previous regulations, the consolidation and up-to-date guidance on Decree 98 will simplify the task of registration and circulation for medical device companies doing business in Vietnam.

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