The letter states that the Ministry of Health has received, processed, and appraised applications for medical device registration and in order for applicants to understand and comply with regulations properly and accelerate appraisal of registration applications according to regulations of Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP, the Ministry of Health would like to request applicants to perform the following tasks:
1. Regularly check the accounts and email addresses to follow the application appraisal process on the online public service system for medical device management
2. Study regulations in Article 25 and Article 26 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP and instructions of use uploaded onto the online public service system to submit the appropriate application following the correct procedure.
3. Review compliance of components of applications such as ISO certificate, certificate of free sale, letter of authorization, etc. submitted to the online public service system with regulations in Articles 26 and 28 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP to prepare to update expired documents at the request of MOH evaluation specialists
4. For a certificate of conformity with ISO 13485 standard per regulations in Clause 1 Article 68 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP:
– The scope written on the certificate must specify the medical device applying for a registration number.
– ISO 13485 certifying bodies operating in Vietnam must comply with regulations in the Government’s Decree No. 107/2016/ND-CP dated 01/7/2016 prescribing conditions for the provision of conformity assessment services, and have their names and scopes of service published on the web portal of Directorate for Standards, Metrology, and Quality – Ministry of Science and Technology.
5. Regulations on the supplement to registration applications:
a) Review registration applications on the online public service system and comply with regulations in Article 29 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP:
b) Remove registration applications that are no longer wish to be considered or are unable to complete.
6. Regarding medical device classification form: review the medical device classification forms and ensure that these forms are published on the web portal of the Ministry of Health according to regulations in Point c Clause 5 Article 66 of Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP, excluding classification results included in registration applications submitted prior to 01/9/2019 according to regulations in Circular No. 42/2016/TT-BYT dated 15/11/2016 by the Ministry of Health.
7. Study regulations on the grouping of medical devices in Circular No. 39/2016/TT-BYT dated 28/10/2016 by the Ministry of Health on the classification of medical devices when preparing registration applications to minimize the number of applications and reduce the pressure of application evaluation on the competent authority.
8. Declare information in registration applications following the guidance provided in Appendix I of this document
Please refer to the link below
Source: Công văn số 7395/BYT-TB-CT ngày 31/12/2020 V/v hướng dẫn chuẩn bị và nộp hồ sơ đăng ký lưu hành trang thiết bị y tế.