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

Regulatory Affairs Services in Vietnam

Regulatory Affairs Services in Vietnam


In Vietnam, regulatory affairs services is becoming more  in demand.  To learn more about regulatory affairs services in Vietnam, we first need to understand what is the regulatory affairs in healthcare field. (see more in what is the Regulatory Affairs?)

Regulatory affairs participate in the whole process after clinical development, beginning  at  drug registration, to regulatory compliance monitoring during product circulation in the market, and product updates according to changes in the national/regional laws and regulatory guidelines, or as mandated by the regulatory authority.

Currently, most business firms have employees for regulatory affairs function. However, the number of employees and working situations in regulatory affairs in each business entity is rather parsimonious. For instance, in manufacturing enterprises and trading businesses in Vietnam, the regulatory affairs employees would be found stationed in factories, in research and development department (for manufacturing companies), or in import-export department (for trading businesses).  Overseas, most exporting companies will have an affiliate in the importing territory who will provide regulatory affairs services until the importer understands the regulatory industry in that territory and can do the work by themselves.

On the other hand, multinational corporations may have regulatory affairs departments in each country where their products would be marketed to take care of product registration, and/or a regulatory hub division that is responsible on a regional scale.

Regulatory Affairs Services can also be outsourced and provided by firms such as:

- Multinational corporations that have a global supply chain system. Apart from regulatory services, these companies also provide marketing services, and even have a service package to take care of products from the manufacturer to the hands of the consumers;

- Multinational law firms and local law firms, who provide regulatory affairs consulting services;

- Local manufacturers and certain businesses that are licensed for manufacturing activities in the pharmaceutical field can also provide regulatory affairs consulting services for companies located outside Vietnam.

In short, to ensure the compliance with regulations and law in each country, regulatory affairs services play a big role, contributing to reduce the cost and time for companies who want to develop and expand in a new market.

In the near future, vnras.com believes that regulatory affairs services will become one of the most developed services in Vietnam.

Edited by Jean Ngo