On 22 April 2026, the Ministry of Health of Vietnam (MOH) and the Ministry of Food and Drug Safety of Korea (MFDS) signed a Memorandum of Understanding (MoU) to enhance cooperation in healthcare-related fields, including pharmaceuticals, food safety, cosmetics, and medical devices.
Signed by MFDS Minister Yu-Kyoung Oh and Vietnamese Health Minister Dao Hong Lan, the agreement replaces the previous MoU concluded in 2018.
While the document covers food, pharmaceuticals, cosmetics, and medical devices, it places clear emphasis on modern medical device regulation amid rapid technological advances.
Read the full announcement here:
Ministry of Health of Vietnam / Ministry of Food and Drug Safety of Korea announcement, April 2026.
Purpose of the MoU
To enhance healthcare regulatory cooperation between Vietnam and Korea across pharmaceuticals, food safety, cosmetics, and medical devices.
To support stronger collaboration in modern medical device regulation, including emerging technologies and post-market oversight.
Scope of Cooperation
The MoU covers cooperation in healthcare-related fields, including:
- Pharmaceuticals
- Food safety
- Cosmetics
- Medical devices
For medical devices, the MoU prioritizes:
- Safety management policies and research
- Administrative procedures for obtaining commercial approval procedures of medical devices
- Post-marketing vigilance
- Evaluation of medical device manufacturing and quality control
Key Highlights
The two sides will further deepen cooperation through:
- Joint clinical trials
- Expert exchanges in emerging fields such as AI, digital health, and biohealth
- Cooperation to tackle medical product shortages
- Promotion of regulatory harmonization
- Information sharing on laws, standards, counterfeit products, adverse events, and recalls
- Facilitation of regulatory reliance pathways
- Strengthened market surveillance communication
- Joint workshops and training programs
A High-level Consultation and specialized Working-level groups will oversee implementation.
Annual meetings will alternate between the two countries.
Implementation Arrangement
The non-binding MoU takes effect immediately and runs for five years, with automatic renewal.
Implications to Clients
Medical device manufacturers and stakeholders should monitor future updates from the relevant authorities as further implementation activities or technical cooperation programs may be developed following this agreement.
The MoU may support closer regulatory cooperation between Vietnam and Korea, including potential developments relating to regulatory reliance, quality system expectations, post-market vigilance, market surveillance, and emerging medical technologies.
Companies operating in or entering the Vietnam market should stay alert to future guidance, pilot programs, or technical cooperation initiatives that may arise from this agreement.
Effective Date
22 April 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.