1. Certification Overview
The existing medical device management department, DMEC (Director of Medical Devices and Construction), was completely abolished, and a new organization to replace it, IMDA (Infrastructure and Medical Device Administration), was launched. This measure, resulting from the reorganization of the Vietnamese Ministry of Health (MOH), was fully implemented starting in January 2025.
Based on the potential risk of medical devices, they are classified into four classes: Class A, Class B, Class C, and Class D, by adopting the ASEAN Medical Device Directive (AMDD) standard specifications.
Low-risk Class A and B products undergo a relatively simplified declaration procedure, while high-risk Class C and D products must undergo the strict IMDA Registration Number approval review based on the ASEAN Common Technical Document (CSDT).
Along with the reorganization of the competent ministry, strengthened procedures have been introduced for the licensing system and post-market surveillance. In accordance with the revised Public Procurement Enforcement Rules of 2025, Korea has been included as an official reference country for state-run hospital bidding, and the Certificate of Manufacturing and Sales (CFS) issued by the National Institute of Medical Device Safety Information (NIDS) has been expanded to include the CFS issued by the Ministry of Food and Drug Safety (MFDS) as an officially recognized document. On the other hand, regulations regarding labeling and advertising have been significantly strengthened, including the complete ban on medical device advertisements utilizing images of medical professionals, such as doctors, to prevent misuse and abuse.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | IMDA (Infrastructure and Medical Device Administration) |
| Quality System | ISO 13485 certification required (based on overseas manufacturing facilities) |
| Lead time / Price | Varies by product |
| Language | Technical and Administrative Documents: English Labels and Instruction Manuals: Vietnamese translation required |
| Agent | A local legal representative is required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class A | Low Risk | • Basic Examination Tools: Mechanical stethoscopes, Tongue depressors • Manual Orthopedic & Mobility Aids: Manual wheelchairs, Hospital beds • Consumables & Wound Care Supplies: Absorbent cotton & Bandages, Surgical drapes |  Consumables & Wound Care Supplies |
| Class B | Low to Moderate Risk | • Basic Electronic Diagnostic Tools: Electronic thermometers, Blood glucose meters • Surgical Protective Wear: Sterile surgical gloves, Surgical gowns |  Electronic thermometers |
| Class C | Moderate to High Risk | • Active Therapeutic & Imaging Systems: Diagnostic X-ray equipment, Electric scalpels • Critical Patient Care Equipment: Infusion pumps, Patient monitors • Non-cardiovascular Invasive Materials: Contact lenses, Urethral stents |  Contact lenses |
| Class D | High Risk | • Central Circulatory & Life-Sustaining Implants: Implantable pacemakers, Vascular stents • Advanced Life-Support Systems: Mechanical ventilators, Anaesthesia machines |  Mechanical ventilators |
4. Certification Process
1. Reporting Procedure (Class A, B product families)
- Submission of Report: Prior to launching Class A and B medical devices in the Vietnamese market, the local legal representative (reporter) authorized by the overseas manufacturer submits a report to the Health Department of the headquarters’ location via the IMDA electronic management portal.
- Information Notice: Once the application is received and system verification is complete, the relevant regional health department immediately uploads the applicable standard notice number (notification number) to the integrated medical device system to approve market distribution.
2. Registration Procedure (Class C, D product families)
- Registration Application: The applicant submits a formal registration application, including the ASEAN Common Technical Document (CSDT), to the Ministry of Health and Medical Devices of Vietnam (MOH-IMDA) through the online medical device management portal.
- Review and Supplementation: The suitability of the documents will be assessed. If the documents are incomplete, the Ministry of Health will issue a Request for Supplementation (MOH Query) within 25 days of receipt. The applicant must supplement and resubmit the documents reflecting the relevant requirements.
- Issuance and Publication of Registration Number: Once the final review is completed, a permanent distribution registration number will be issued upon approval by the Minister of Health, and product information will be officially published on the portal system within one business day from the date of issuance.
3. Fast-track registration process
- Eligibility: Applications are limited to Class C and D products holding the first approval from a global reference country recognized by the Vietnamese Ministry of Health (Korea MFDS, US FDA, Europe CE, etc.).
- Simplified Review: In principle, if the application is complete, approval and registration number will be issued within the statutory processing period of 10 days. If there are any deficiencies, a request for supplementation will be sent within 10 days.
5. Required Documents
| Medical device notification (Class A) | • Declaration Form for Applicable Standards (MOH Official Template) • Quality Management System Certificate (Copy of ISO 13485 Certificate – Valid for at least 6 months required) • Manufacturer’s Power of Attorney (POA) and Warranty Letter (Vietnamese Consular Authentication/Apostille required) • Certificate of Free Sale (CFS) (Issued by the Government of Origin and Vietnamese Consular Authentication required) • Vietnamese Instruction Manual (IFU) and Label Sample (Vietnamese text required) • Product Catalogue & Technical Specifications |
| Medical Device Registration (Common to Class B, C, and D) | • Application for Issuance of New Distribution Registration Number (Application Form – Official Form) • Quality Management System Certificate (Copy of ISO 13485 Certificate) • Power of Attorney (POA) and Local Warranty Letter from the Medical Device Owner (Manufacturer) (Vietnamese Consular Authentication Mandatory) • Certificate of Free Sale (CFS) (Issued by the Country of Manufacture and authenticated by the Vietnamese Consulate / For Korea, both versions issued by the Ministry of Food and Drug Safety and NIDS are accepted) • Common Technical Documentation Dossier (CSDT) • Vietnamese Label Sample and Instruction Manual (IFU) |
| Medical device registration number fast-track | • Application for Issuance of New Distribution Registration Number • Quality Management System Certificate (ISO 13485) • Power of Attorney (POA) and Quality Assurance Certificate • Certificate of Free Sale (CFS) or License from an accredited country • (Replacement of Old Law Reversion Provisions) For products that have a distribution history in Vietnam under a temporary import permit obtained under the previous old law regime, you may request an expedited transition review by attaching copies of the existing Import License and customs clearance history documents issued at that time. |
For Class B, the notification procedure is followed, but the documentation requirements must comply with the ASEAN Common Technical Document (CSDT) standards, identical to those for Classes C and D.
6. Validity Period and Maintenance
- Authentication Validity Period: Indefinite
- ISO 13485: 3 years
- Certificate of Free Sale (CFS / FSC): Proceed according to the issuing country
Source
IMDA Homepage