Vietnam issues guidance document on preparing medical device registrations
Vietnam’s Ministry of Health recently released a guidance document no. 7395/BYT-TB-CT on preparing medical device registrations. The aim of the document is to help applicants better understand and comply with regulations to speed up the appraisal of registration applications and thereby facilitate the circulation of medical equipment on the market.
In accordance with the provisions of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, Decree No. 03/2020/ND-CP, the Ministry of Health (MoH) informs and requests applicants to:
1. Regularly check the accounts and email addresses of applicants to monitor the progress of the appraisal of registration applications via the online portal. This will facilitate a speedier introduction and continued circulation of medical equipment in the market.
2. Carefully study the provisions of Articles 25 and 26 of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and instruction documents posted on the online system. This is to help applicants choose the correct form and follow the correct procedures in submitting applications for the registration of medical equipment. This will help avoid having to resubmit the application.
3. Review documents required such as ISO quality management certificate, certificate of free sale, letter of authorization … submitted on the online portal according to regulations in Article 26, Article 28, Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and ensure that any documents that about to expire are updated as MoH evaluation experts may request these at any time.
4. Ensure compliance of ISO 13845 certificates of quality management as prescribed for in Clause 1, Article 68 of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP by verifying that:
– that the scope of the quality management system on the ISO 13845 certificate corresponds to the medical equipment applying for the registration, for example: for an ultrasound machine, the scope on the certificate must state ultrasonic machine manufacture.
– that any ISO 13485 certificates issued by organizations operating in Vietnam comply with the Government’s Decree No. 107/2016/ND-CP dated July 1, 2016 regarding business conditions for conformity assessment services. Also, that the scope of certification of the organization in Vietnam is posted on the web portal of the General Department of Standards and Measurement Quality, Ministry of Science and Technology.
5. Check the additional provisions concerning the submission of registration applications for medical equipment and in particular to:
a) review the registration application on the online portal to ensure compliance with Article 29 of Decree No. 36/2016 /ND- CP and Decree No. 169/2018/ND-CP which state that if within ninety (90) days of the date of the written request by the Ministry of Health, the applicant does not supplement or amend the registration application OR if after five (5) amendments the application still fails to meet the requirements, the registration application must be started afresh.
b) consider deleting any documents for medical devices for which they no longer wish to pursue registration, or for which they are unable to supplement or complete the registration application.
6. Check the medical equipment classification and ensure it has been published on the Ministry of Health’s website according to regulations Point c, Clause 5, Article 66 of Decree No. 36/2016/ND-CP, and Decree No. 169/2018/ND-CP. This does not apply to results of classification submitted as part of registration applications for medical equipment before September 1, 2019 according to the provisions of the MoH’s Circular No. 42/2016/TT-BYT dated November 15, 2016.
7. Utilize groupings of medical equipment registrations where possible and in accordance with Circular No. 39/2016/TT-BYT dated October 28, 2016 from the Ministry of Health detailing the type of medical equipment. This will help minimize the number of submissions and so reduce pressure on regulators to review records.
8. Complete the information as required in registration applications of medical equipment according to the instructions in Appendix I.
If you would like more information or are interested in registering your medical device in Vietnam please send us an email to [email protected]