new vietnam medical device regulations proposed

New Vietnam Medical Device Regulations Proposed

The Vietnamese Ministry of Health (MoH) has published a draft decree which is intended to replace Decree No. 36/2016/ND-CP and its amendments, which currently form the legal framework for regulating medical devices in Vietnam. The draft was released as Official Dispatch No. 2271/BYT-TB-CT on 31 March 2021.

In order to unify Vietnam’s medical device regulations the draft decree on medical device management proposes to replace the following 3 decrees:

  • Decree No 36/2016/NĐ-CP dated on 15 May 2016
  • Decree no 169/NĐ-CP dated on 31 December 2018
  • Decree No 03/2020/NĐ-CP dated on 01 January 2020

The draft decree consolidates and supplements existing Vietnam medical device regulations through the following provisions by:

Reviewing business conditions and administrative procedures:

  • Supplement existing regulations related to medical device advertisements in Vietnam
  • Amend and supplement the existing regulation on applications for declaration of eligibility for medical device classification, production and trading.

Amending and supplementing existing regulations as well as adding new regulations to meet the practical requirements of medical device management, and completing the system of legal documents for medical devices:

  • Add a new classification rule for medical devices that form part of a system used in combination with other medical devices with many purposes
  • Modify the concept of medical supplies
  • Supplement existing regulations on medical device clinical trials
  • Add new regulations on the import and export of products and goods containing narcotic substances or precursors, excluding drugs or medical device such as products for quality control testing
  • Supplement the existing provision that raw materials for the manufacture of medical devices do not require import or export permits, except for raw materials containing narcotic substances and precursors
  • Amend and supplement existing regulations on technical documents for domestically produced medical devices and products used to disinfect medical devices
  • Amend and supplement existing regulations related to the issue of registration numbers for medical devices of class B, C, and D that have obtained import permits
  • Supplement the existing regulations on the import of in vitro diagnostic bio-products and medical devices (by abolishing the provisions in Circular 47 and Circular 30) during the transitional period before  issuing registration numbers for the free circulation of medical devices
  • Add a new provision on medical devices containing drugs when registering for circulation or an import license which take effect from the date of issue
  • Supplement existing regulations on import licenses for medical devices used for individual purposes or in emergency situations, epidemics or natural disasters.

To read the draft decree in full please note it is currently only available in Vietnamese from the Ministry of Health website

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