Certification Introduction
Vietnam implements a statutory risk classification-based access system for medical devices exported or launched from overseas. The review is administered by the Department of Medical Equipment Administration (DMEC) under the Ministry of Health of Vietnam, and local health departments issue import licenses. Vietnam adopts the unified classification rules of the ASEAN Medical Device Directive (AMDD), classifying products into four categories A, B, C, D from low to high risk, corresponding to different compliance paths. Overseas manufacturers are mandatorily required to appoint a local authorized representative in Vietnam, and all applications must be submitted via DMEC's DA VINCI electronic system.
Laws and Regulations
Core current regulations include:
- Circular 30/2015/TT-BYT: Basic regulation for medical device management
- Circular 39/2023/TT-BYT: Major revised regulation that takes effect in 2024
- Decree 98/2021/ND-CP: Management provisions for medical device compliance penalties The overall framework follows the unified ASEAN medical device regulatory coordination rules, please refer to the latest announcements on the official website of DMEC, Ministry of Health of Vietnam for specific classification and requirements.
Technical Requirements
- Quality management system: Overseas manufacturers must hold a valid ISO 13485 certification certificate.
- General testing standards: Electrical medical devices comply with IEC 60601 series safety standards, biocompatibility evaluation complies with ISO 10993, risk management complies with ISO 14971, and test reports must be issued by ILAC-accredited laboratories.
- Document requirements: A country-of-origin marketing certificate and a notarized and double-authenticated Free Sale Certificate must be provided. All foreign language documents shall be accompanied by Vietnamese translations, and product labels and instructions must include Vietnamese markings.
- Clinical requirements: Medium and high-risk products are required to provide clinical evaluation reports. Existing clinical data from the country of origin is acceptable, only a description of data applicability needs to be supplemented.
Certification Process
- Confirm product risk classification and appoint a qualified legally compliant local authorized representative in Vietnam
- Prepare complete set of application materials and technical documents in accordance with Vietnamese regulatory requirements
- Submit registration application via the DA VINCI electronic system and pay official fees
- DMEC conducts document review, medium and high-risk products need to supplement materials or accept on-site inspection as required
- Obtain the medical device registration certificate after passing the review, then apply for an import license from the local health department
- The registration certificate is valid for 5 years, and renewal procedures must be completed before expiration
WANVE, as a professional technical service organization, provides one-stop full compliance support for enterprise export.