How to Register a Healthcare Product in Vietnam

How to Register a Healthcare Product in Vietnam 

The basic steps to register a healthcare product as required by Vietnam Ministry of Health are as follows:                                                                                              

1. Know the product classification:

In Vietnam, various products are generally classified as follows:  drugs, vaccines, biologicals, food supplements/functional foods, cosmetics, medical devices, insecticidal- or germicidal chemicals, and preparations for household and medical use.

2. Know the correct and applicable regulations for each product:

Some regulations can still be used as valid reference to register and announce products in Vietnam (validity up to December 2016):

- For drugs, vaccines, biologicals: refer to Circular 44/2014/TT-BYT dated November 25, 2014 regarding registration.

- For medical devices: refer to Decree 36/2016/ND-CP "Medical Equipment Management" dated May 15, 2016 and Circular 30/2015/TT-BYT "Importation of Medical Equipment" dated October 12, 2015.

- For functional foods: refer to Circular 43/2014/TT-BYT "Management of Functional Foods" dated November 24, 2014.

- For cosmetics: refer to Circular 06/2011/TT-BYT "Cosmetic Management" dated January 25, 2011.

- For insecticidal- or germicidal chemicals and preparations for household and medical use: refer to Circular 29/2011/TT-BYT dated June 30, 2011 regarding management of insecticidal- or germicidal chemicals and preparations for household and medical use.

3. Registration and announcement of the product:

Registration and declaration dossier of each product are detailed in the aforementioned regulations.

The licensing agencies for each product are all governed under the Ministry of Health of Vietnam:

- Drug Administration of Vietnam (DAV): for drugs, vaccines, biologicals, cosmetic.

- Department of Medical Equipment and Construction (DMEC):  for medical devices.

- Vietnam Food Administration (VFA):  for functional foods.

- Vietnam Health Environment Management Agency (VIHEMA): for insecticidal- or germicidal chemicals and preparations for household and medical use.

4. Getting Marketing Authorization, Free-Sale Certificate, Importation License, and Announcement Letter of products:

After the product has been submitted to the competent authority for evaluation, the competent authority will grant the respective certificates for importation and for marketing of the product in Vietnam.

Products in the process of circulating must be periodically monitored, and any issues must be reported to the Ministry of Health as directed in the relevant regulations.

                                                                        

Edited by Jean Ngo