Currently, Medical Devices in Vietnam are managed by the Decree No. 36/2016/ND-CP dated May 15, 2016; Decree No. 169/ND-CP dated December 31, 2018; and Decree No. 03/2020/ND-CP dated January 1, 2020. To unify regulations on device management, the Ministry of Health has developed a draft Decree on medical device management to replace the above 03 Decrees. The Ministry of Health will collect comments and complete the draft decree.
The main amendment contents include:
1. Definition
The Ministry of Health added new definitions for Personal-specific medical equipment, Clinical evaluation report, Clinical evidence, Clinical experience, and Clinical Trials of Medical Device.
2. Clinical Trials of Medical Device
This section is totally new in Medical Device management. The draft decree regulates stages of Clinical evaluation; Medical Devices subject to clinical evaluation, medical equipment exempt from clinical evaluation, or exempt from some stages of clinical evaluation. Moreover, requirements and dossiers for Clinical Trials of Medical Device; Language, formats, and legal requirements of the dossiers; Procedures for register and approval of Study and Result of Clinical Trials of Medical Device are also stated in this draft decree.
3. Medical Device Circulation
There are more specific requirements for technical documents.
- Disinfecting medical devices and Domestic medical equipment will use their own formats.
- Clinical Evaluation Report, Inspection certificate, Product Efficacy Test, Biocompatibility Test, Analysis Test are required for specific products.
- CSDT (ASEAN Common Submission Dossier Template) will be expected to apply from 2022.
The draft decree added 2 more cases for quick application of product registration. The Ministry of Health also extends the period of reviewing dossiers.
4. Medical Device Advertisement
This article is also new. Medical device advertisement is applied for approved products only. License holders or Organization authorized by the holder have to publicly post on DMEC the proposal advertisement contents and take full responsibility for these contents
5. Transitional Regulations
Approved Import Permit License will be extended validation until 2022/12/31.On the other hand, a procedure for application import permit license for in vitro diagnostic medical equipment that are reagents, calibrators, and in vitro control materials of categories B, C from January 1, 2020, to January 31, 2020, December 2021 are regulated specifically on this draft decree.
Reference:
Draft decree of medical device management.