Certification Introduction

Vietnam implements a statutory risk-based access system for medical devices intended to be placed on its domestic market, supervised by the Infrastructure and Medical Device Administration (IMDA, formerly DMEC) under the Ministry of Health of Vietnam. Vietnam adopts the unified classification rules of the ASEAN Medical Device Directive (AMDD), which divides products into four categories A, B, C, D from low to high risk, corresponding to differentiated compliance paths.

Laws and Regulations

Core current regulations include: Circular 30/2015/TT-BYT: Basic regulation on medical device management Circular 39/2023/TT-BYT: Major revised regulation that entered into force in 2024 Decree 98/2021/ND-CP: Provisions on compliance penalty management for medical devices The overall regulatory framework follows the unified ASEAN medical device regulatory coordination rules. For specific classification requirements, review details and process adjustments, please refer to the latest announcements on the official website of IMDA under the Ministry of Health of Vietnam.

Technical Requirements

According to ASEAN AMDD rules, Vietnam divides medical devices into four categories A, B, C and D, and different risk levels correspond to differentiated compliance and technical control requirements. Overseas manufacturers must hold a valid ISO 13485 quality management system certification to meet the quality control requirements for the full product lifecycle specified by Vietnamese regulations. If you hold a reference national/regional certification, the review process can be accelerated: Japan, Canada, Australia, the United States, the European Union, the United Kingdom, China, South Korea. Electrical medical devices must comply with the IEC 60601 series safety standards, biocompatibility evaluation must comply with ISO 10993, risk management must comply with ISO 14971, and relevant test reports must be issued by ILAC-accredited laboratories. It is required to provide the marketing certificate of the country of origin, and the notarized and double-certified free sales certificate. All foreign language application documents must be accompanied by professional Vietnamese translation, and product labels and instructions must include Vietnamese markings. For medium-high risk Class C and D products, a clinical evaluation report is required. Existing clinical data from the country of origin can be accepted, and only a supplementary description of data applicability is required. It is necessary to establish a post-market adverse event monitoring and feedback mechanism, and continuously fulfill post-market compliance obligations.

Certification Process

Confirm the product risk classification and clarify the corresponding compliance path and registration requirements.

Appoint a Local Authorized Representative (LAR) that meets the requirements of Vietnamese regulations, serving as the statutory liaison between overseas manufacturers and regulatory authorities.

Prepare a full set of application materials and technical documents in accordance with Vietnamese regulatory requirements, and complete the translation, notarization and double certification procedures.

For low/medium-risk Class A and B products, the licensee submits a declaration of applicable standards to the local health bureau through the local authorized representative and completes the formal review. 5 After approval, the local health bureau will issue a notice of applicable standards.

For medium-high/high-risk Class C and D products, the licensee submits a marketing registration application to the Infrastructure and Medical Device Administration (IMDA) of Vietnam through the DA-VINCI system. After review and approval, the "Marketing Authorization License (MA License)" will be issued.

After the product is legally placed on the Vietnamese market, it is necessary to continuously fulfill regulatory obligations such as post-market adverse event reporting and annual compliance update.

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