A marketing authorization (MA) license to register Class B, C, and D medical devices with Vietnam’s Ministry of Health (MoH) will only be required starting January 1, 2019 onwards.
This means that the MA regime for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. This key announcement came via the Official Dispatch No. 7165/BYT-TB-CT, released on December 14, 2017 by the MoH, which is a very important notification and comprise of new regulations relating to the implementation of Decree No. 36/2017/ND-CP (Decree 36) on medical device management. Dispatch 7165 provides specific guidance on the registration regime of Class B, C, and D devices, as well as in vitro diagnostic (IVD) biologicals.
Earlier on, the Ministry of Health had developed the official online platform to receive medical device registration dossiers. However, in the course of implementation, some problems arose. At present, the Ministry of Health has not yet been able to link the online public services level 4 to the registration of circulation of medical equipment with the national gateway information system as agreed with the General Department of Customs from January 1, 2018.
In addition, on October 11, 2017, the Ministry of Health received an official letter from the European Business Association in Vietnam (EuroCharm), stating some difficulties and problems in the preparation and implementation of circulation registration for medical equipment. Class B, C, D: Only 15 companies of the EuroCharm group are trading medical equipment but more than 40,000 products correspond to about 4,000 circulation registrations, and it is difficult to complete the preparation of application for circulation in 4 months (to be licensed on 1.1.2018 must be submitted before 1.11.2017) Owners cannot provide timely information and documents for submission due to the large number of applications and requests between different countries and the manpower at the company does not meet the preparation of the dossier due to the large volume of documents and the need to translate the manuals into Vietnamese, apart from preparation of labels and legal documents.
Thus, with the official release of the Dispatch 7165, from now until January 1, 2019, some specific interim regulations set forth under the new Official Dispatch are as follows:
- Class B, C, and D medical devices which were included in the enclosed annex of Circular 30/2015/TT-BYT dated October 12, 2015 on promulgating the importation of medical devices (Circular 30) will continue to be governed by the regulations of Circular 30.
1. For medical equipment classified as class A: To continue to comply with the provisions of Decree No. 36/2016/ND-CP.
2. For class B, C and D medical device which were included in the enclosed annex of Circular No. 30/2015/TT-BYT on promulgating the importation of medical devices: shall continue to comply with the provisions of Circular No. 30 until December 31, 2018.
3. For class B, C and D medical device which were not included in the enclosed annex of Circular No. 30/2015/TT-BYT: continue to comply with the contents Guidance on importing medical equipment in Official Letter No. 3600/BYT-TB-CT dated June 26, 2017 of MOH until December 31, 2018.
4. The registration of in-vitro diagnostic bio-products continues to comply with Circular No. 44/2014/TT-BYT and the import of in-vitro diagnostic bio-products continues to comply with the provisions of Circular No. 47/2010/TT-BYT until 24h00 on December 31, 2018. In-vitro diagnostic bio-products that have been granted circulation numbers will continue to be imported until the expiry date stated in the permit.
5. For import licenses issued and valid on December 31, 2017: Where the authorization letter of the owner is valid after December 31, 2017, The agency shall send a written request to the MoH (Department for Medical Equipment and Works - DMEW) for consideration and extension of the validity of the import permit according to the regulations under Article 16 of Circular No. 30/2015/TT-BYT.