Regulatory Process for Medical Device in Vietnam

Regulatory Process for Medical Device in Vietnam

Trading a medical device in Vietnam requires manufacturers and traders to comply with the regulations and registration process by Vietnam authorities. (See regulations on the management of medical device in Vietnam).

The registration process for medical device is governed by the Ministry of Health's Department of Medical Equipment and Construction (DMEC) and Health Services (HS).  Take a look at the flow-chart and step-by-step guide on the registration process below:

Step 1:

Apply for a Marketing Authorization (MA) certificate.  For foreign companies that do not have representative offices yet in Vietnam, appoint a Marketing Authorization Holder (MAH) in the territory. (See "Requirements for Organizations Declaring Applicable Standards" or "Applying for Registration of Free Sale of Medical Equipment in Vietnam.")

Step 2:

Classify the medical device, according to Circular 39/2016/TT-BYT: "Classification of Medical Equipment" dated October 28, 2016.

Medical equipment in Vietnam are classified into 2 groups, which are divided into 4 types depending on the possible levels of risk related to the design and production of such medical equipment:

Group	Class	Risk level
1	A	Low
2	B	Lower average
	C	Upper average
	D	High

See "Requirements to be Satisfied by Organizations Conducting Classification of Medical Equipment."

Step 3:

**For medical device Class A, the declaration of applicable standard dossier must be submitted to Health Services.

Class A medical equipment can be freely sold only when the Receipt Note for the Declaration of Applicable Standard has been issued by Health Services.    

For the required dossiers and procedures for submitting a Declaration of Applicable Standard, refer to Articles 22, 23, 24 Decree 36/2016/NĐ-CP: "Medical Equipment Management" dated May 15, 2016 (hereinafter referred to as "Decree 36").

**For medical device Class B, C, D, the free sale registration dossier must be submitted to DMEC. 

Medical equipment Class B, C, D shall be freely sold only when validated by the inspection council of the Ministry of Health and granted with a certificate of free sale.

For the required dossiers and procedures to apply for the Certificate of Registration of Free Sale, refer to Decree 36.

Free-sale registration number of medical equipment means:

- The number of the receipt note of the Declaration of Applicable Standard for Type A medical equipment. To apply, use Form No. 03 as provided in Annex IV of this Decree.

- The number of the Certificate of Registration of Free Sale for Types B, C and D medical equipment.  To apply, use Form No. 09 as provided in Annex IV of this Decree.

** Note: All application procedures can be done online.




Edited by:  Jean Ngo