Vietnam’s Ministry of Health (MoH)

The Vietnam Ministry of Health is the national regulatory body and competent authority in the country established in 1945. Its main offices are located in the capital city of Hanoi. As the primary governing body responsible for the country’s healthcare system, the MOH works to improve public health, formulate health policies, regulate medical services, and promote health education initiatives. 

In recent years, the ministry has focused on improving the quality of healthcare services, disease prevention and control measures, and increasing access to healthcare for vulnerable populations. The main roles of the Vietnam Ministry of Health include healthcare regulation, pharmaceutical oversight, disease surveillance/control, food safety/nutrition and health policy development.  

Recent History of the Vietnam MoH

One of the most critical policy changes from of the Ministry of Health recently has been the management of the Covid-19 pandemic, including contact tracing, testing and quarantine measures that have kept cases and deaths relatively low in Vietnam.  

Another more recent regulatory update from the Vietnamese Ministry of Health came in 2021 when Decree 98/2021 ND-CP was released, updating the rules governing medical device registration in the country. With an update to that decree that occurred in January of 2022, manufacturers seeking registration could now apply for Market Authorization licenses. 

The ministry in recent years has also worked to improve access to medical services. In recent years, the government has built new hospitals and clinics in rural areas to improve access to healthcare services for remote areas. The ministry has also implemented policies aimed at improving the affordability of healthcare services and reducing out-of-pocket costs for patients.  

The Vietnam MoH enforces compliance with internationally recognized standards, such as ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission), for manufacturing and quality management systems. 

Significant Recent Vietnam MoH Updates

The Vietnam MoH has made several regulatory updates within the last several years including: 

Decree No. 98/2021/ND-CP – effective Jan 1st, 2022:  

Decree passed on the management of medical devices 

Decree No. 111/2021 – effective December 9th, 2021: 

This Decree amended Decree No. 43/2017 and focused on updating Labeling requirements 

Circular 05/2022 – effective August 1st, 2022: 

Provided a list of products that require registration prior to importation. 

Decree 07/2023 (EN/VN)– Extends the validity of Import Licenses for medical devices and delays the implementation of CSDT application requirements.  

Recent Blogs on Vietnam

Vietnam Extends Validity of Medical Device Import Licenses 

The Vietnamese MoH Issues Draft Decree to Address Delays 

Vietnam’s DMEC Provides Update on Issuance of Class C and D MA Licenses 

Vietnam’s Ministry of Health Holds Conference on New Price Declaration Procedures 

Vietnam Requires Submission of Many Medical Device Registration Applications 

More Information on Vietnam MoH Regulatory Requirements for Medical Devices

Vietnam Ministry of Health News/Updates 

Our Overview of the Vietnam Medical Device Registration Page 

List of Public Administrative Services Provided by the Vietnam Ministry of Health 

Come Grow With Us

Contact Asia Actual if you have any questions and/or would like to learn more about accessing the Vietnam market specific to your product portfolio. 

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.