Question 1

What is Vietnam's MOH and DAV, and why are they important for medical device manufacturers?

Accepted Answer

Vietnam's Ministry of Health (MOH) oversees pharmaceutical and medical device regulation through the Drug Administration of Vietnam (DAV). DAV is responsible for device registration, import licensing, market surveillance, and post-market safety. All medical devices marketed in Vietnam require registration (CFS or Announcement depending on class) and import licenses. Foreign manufacturers must designate Vietnamese agents and partner with licensed Vietnamese importers/distributors. Vietnam is actively implementing ASEAN Medical Device Directive (ASEAN MDD) harmonized requirements, which are modernizing the regulatory landscape.

Question 2

What are CFS and Announcement registration pathways?

Accepted Answer

CFS (Circulation Free Sale Certificate): Required for Class B, C, and D devices (medium to high risk), full technical review by DAV, includes device-specific registration with comprehensive documentation, valid for 5 years (renewable). Announcement: Available for certain Class A devices (low risk), simplified notification process, less extensive review than CFS, shorter processing time. Key Requirements for Both: Vietnamese agent designation, licensed Vietnamese importer/distributor, manufacturer quality certificate (ISO 13485 or equivalent), free sale certificate from country of origin, conformity certificate (CE marking, FDA approval, etc.), technical documentation, labeling and instructions for use (Vietnamese language). Timelines: CFS: 6-12 months, Announcement: 2-4 months. Import license required separately after CFS/Announcement approval.

Question 3

How does Vietnam classify medical devices?

Accepted Answer

Vietnam follows the ASEAN Medical Device Directive (ASEAN MDD) risk-based classification system: Class A: Low risk (e.g., non-invasive devices, minimal body contact), some Class A may use Announcement pathway, Class B: Low-medium risk (e.g., channeling devices, short-term invasive), requires CFS with moderate technical review, Class C: Medium-high risk (e.g., long-term invasive, active therapeutic), requires CFS with extensive documentation, Class D: High risk (e.g., implantable, life-sustaining, drug-device combinations), most stringent CFS requirements and clinical data. Classification based on: invasiveness, duration of contact, whether device is active, intended purpose and critical nature. ASEAN MDD alignment facilitates regional harmonization and acceptance of international certifications.

Question 4

What is a Vietnamese Agent and what are their responsibilities?

Accepted Answer

A Vietnamese Agent (also called Authorized Representative or Legal Representative) is a person or legal entity domiciled in Vietnam designated by a foreign manufacturer to represent them with DAV and MOH. Requirements: Must be domiciled in Vietnam with valid business registration, registered with DAV for the specific manufacturer and device(s), Responsibilities: Submit CFS or Announcement applications to DAV, maintain technical documentation, certificates, and registration files, serve as liaison between foreign manufacturer and DAV/MOH, handle post-market surveillance and adverse event reporting, coordinate product recalls and corrective actions, ensure compliance with Vietnamese labeling and language requirements. Distinction from Importer: Vietnamese Agent represents the manufacturer, licensed importer/distributor handles commercial import and distribution, often the same entity serves both roles. A Vietnamese Agent is mandatory for all foreign manufacturers seeking Vietnam market access.

Question 5

What are Vietnam's import license requirements?

Accepted Answer

After obtaining CFS or Announcement, a separate import license is required to physically import devices into Vietnam. Import License Process: Issued to Vietnamese importer/distributor (not foreign manufacturer), requires valid CFS or Announcement for the device, annual application (typically renewed yearly), must demonstrate continued compliance with regulations. Vietnamese Importer Requirements: Licensed business entity in Vietnam, appropriate business license scope for medical devices, qualified personnel for medical device handling, adequate facilities and quality systems. Practical Implications: Foreign manufacturers must partner with licensed Vietnamese importer, importer handles both CFS/Announcement application and import licensing, changes in importer require transfer of CFS/Announcement and new import arrangements. Import license is separate from but dependent on CFS/Announcement approval.

Question 6

What quality and conformity certificates does Vietnam DAV accept?

Accepted Answer

DAV requires manufacturers to demonstrate quality management and device conformity for registration. Quality Certificates (Manufacturer): ISO 13485 certification (most common and preferred), CE marking certificate (indicates ISO 13485 compliance), FDA establishment registration, WHO-GMP certificate, other internationally recognized QMS certificates. Conformity Certificates (Device): CE marking from EU Notified Body, FDA 510(k) clearance or PMA approval, TGA (Australia), Health Canada license, other recognized regulatory approvals, free sale certificate from country of origin (mandatory). Certificate Requirements: Must be current and valid, issued by accredited certification body or recognized regulator, cover the specific manufacturing site(s) and device models, translated to Vietnamese if required by DAV. International certificates facilitate DAV review under ASEAN MDD framework and demonstrate international acceptance.

Question 7

How often is Vietnam medical device regulatory news updated and how can I stay informed?

Accepted Answer

Vietnam's MOH and DAV regularly publish decrees, circulars, and guidance documents related to medical device registration, ASEAN MDD implementation, and post-market requirements. Recent years have seen significant modernization and harmonization efforts. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Asia Actual, and Citeline. We recommend checking this page regularly and working closely with your Vietnamese agent and importer to monitor DAV announcements and regulatory changes.

Question 8

What commercial sources does this platform use for Vietnam news?

Accepted Answer

We aggregate Vietnamese regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic DAV announcements, helping you navigate CFS/Announcement pathways, Vietnamese agent designation, import licensing, ASEAN MDD compliance, and Vietnamese labeling requirements.

Vietnam MOH Medical Device News 2025: Registration & Regulatory Updates | Pure Global

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