Medical Device Regulations and ISO 13485: Historical Reference

The original article discussed expected regulatory changes in 2014. The checklist below is preserved as historical information, not as a current mandatory procedure. For present projects, determine the device classification, business activity and current legal requirements using official sources.

1. Original checklist — historical reference

1. Arrange facilities to meet hygiene requirements and prevent cross-contamination.
2. Apply for authorization confirming manufacturing eligibility.
3. Appoint a suitably qualified person responsible for professional oversight of manufacturing.
4. Classify products into groups A, B, C and D.
5. Conduct initial inspection or testing of products in groups B, C and D.
6. Apply for a product circulation registration number.
7. Apply for a Certificate of Free Sale (CFS) for export products.
8. Obtain safety confirmation for products already lawfully marketed.
9. Seek clinical investigation authorization for devices whose design and verification have been completed.
10. Declare conformity with applicable standards and technical regulations before placing products on the market.

The original article also referred to annual reporting before 31 January. This historical statement must not be treated as a verified current deadline.

2. Check applicable requirements

Determine the rules and procedures applicable to each product, activity and implementation date. Start with the consolidated medical device regulation and relevant circulars; ISO 13485 certification does not replace regulatory procedures.

Ministry of Health — consolidated document 08/VBHN-BYT (2026, Vietnamese)

Circular 24/2026/TT-BYT (Vietnamese)