Important Registration Regulations for Exporting Health Care Products to Vietnam

March 31, 2022  Source: Ddu 4,780


With the continuous improvement of living standards in recent years, the Vietnamese people’s demands for healthcare products have increased significantly. Compared with others, Vietnamese acceptance of healthcare products is later than most other countries. It was only in the 1990s that healthcare products, mainly imported from the United States, gradually entered the Vietnamese market. Later healthcare products from China, South Korea, Belgium and a number of other countries also started entering the Vietnamese market. Due to the small scale of domestic production and relatively limited varieties, the sales of healthcare products in Vietnam are still mainly dependent on imports.


According to statistics, there are approximately 1,800 companies that produce and sell health products in Vietnam with a total of 10,000 varieties. What kind of issues do foreign companies need to pay attention to when trying to enter the Vietnamese market? Today, Ddu will give you a brief introduction on how to cross the first threshold from the perspective of registration in regards to exporting products to Vietnam.


In Vietnam, functional foods (TPCN, Thựcphẩmchứcnăng) are used to support (restore, maintain or enhance) the function of human organs, with (or without) nutritional effects, these foods (or products) can make our bodies comfortable, enhance the capacity of resistance and reduce the risk of contracting diseases. According to their purpose, the content of trace elements and the method of ingestion, functional foods are also divided into trace element supplements, food supplements, health products and nutritional products.


If you want to export functional foods to Vietnam, the first step is to register with the Food Safety Department (Cục An toàn thực phẩm) under the jurisdiction of the Ministry of Health of Vietnam to obtain a “passport” for selling in Vietnam. The valid duration for a registration certificate is 3 years.

According to the Vietnamese Decree 38/2012/ND-CP, registration requires the submission of the following documents:

1. Detailed product information (requires the signature and official seal of the person in charge of the manufacturer);

2. A free sales certificate issued by the competent authority of the country of origin or other equivalent documents to prove that the product complies with local regulations (subject to embassy accreditation);

3. Inspection report issued by the national competent authority, an independent Vietnamese laboratory (original or notarized copy) or a local laboratory of the original country (original or copy certified by the embassy) approved by the competent national authority within the last 12 months, the test report should cover the main quality and safety indicators;

4. Internal self-inspection plans and reports from the enterprise;

5. Labels language used in the country of origin and labels in Vietnamese;

6. Product samples;

7. A business license containing the scope of food business;

8. Certificates to prove that the production facility meets the food safety requirements;

9. Certificate of HACCP or ISO 22000 or equivalent (notarized copy).


Here are 2 recommended practical websites regarding the exporting of healthcare products to Vietnam.

1. Ministry of Health of Vietnam:

The official website of the Ministry of Health of Vietnam where you can check the latest official policies.

2. Vietnam Functional Food Association:

The website has a lot of market conditions related to Vietnamese health products.

By Ddu

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