Vietnam – Regulatory Affairs
Vietnam is one of the most promising pharma markets in Asia. The Drug Administration of Vietnam is the country’s pharmaceutical product regulator, and the Department of Medical Equipment and Health Works under the Ministry of Health is its Medical Device regulator. All pharmaceuticals in Vietnam require both product approval and a separate import permit from the DAV. Only selected Medical Devices require approval for marketing.
Regulatory Body - DAV and MOH
The regulatory bodies in Vietnam responsible for the registrations of drug products and medical devices are called the Drug Administration of Vietnam (DAV) and the Department of Medical Equipment and Health Works respectively (DMEHW). For food supplements, the regulatory body is the Vietnam Food Administration. Both the DMEHW and the Vietnam Food Administration are units under the Ministry of Health (MOH).
Pharma Prescription Drugs
To be distributed in Vietnam, a prescription drug must have a marketing authorization number issued by the DAV. Marketing authorization numbers are issued following the receipt of a completed application dossier and all supporting documents. Drugs granted marketing authorization number can be imported into Vietnam without an import license.
Consumer Healthcare Drugs/OTC
OTC drugs and prescription drugs for distribution are subject to similar registration processes. However, there are several exceptions that could help fast track the registration process or allow for import and distribution without marketing authorization numbers for certain OTC drugs. With our long-term experience and network with the DAV, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in Vietnam.
In Vietnam, Medical devices are divided into four type – Classes A, B, C, and D based on their level of risk. The rules for device classifications are quite specific and can vary greatly depending on different criteria. All medical devices imported into Vietnam are required to register for registration licenses via the submission of a registration dossier to the relevant medical device authority which is either the Department of Health or the DMEHW depending on the class. Class B, C, and D medical devices also must have a valid import license.
Food supplements and nutraceuticals in Vietnam are regulated by the Vietnam Food Administration under the Ministry of Health (MOH). Any food supplements and health food products must be registered with the relevant authority and an application must be submitted to the Vietnam Food Administration. Once approved, a certificate is issued by the MOH.
Cosmetics and Derma
Cosmetics are defined as substances or a preparation used for touch with the outer parts of a human body (skin, hair system, fingernails, toenails, lips, and external reproductive organs) or teeth and mouth mucous membrane, whose purpose is to cleanse, aromatize, change the external characteristics or form, adjust body smell, safeguard body, or maintain the human body to always be in a good condition. In Vietnam, cosmetics registration is managed by the Drug Administration of Vietnam (DAV). All imported cosmetics products must be registered, but registration is quite straightforward requiring the submission of a set of documents.
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in Vietnam?
- What are the important things to take understand with regards to
trademarks by the DAV?
- Can my home company act as a MAH in Vietnam?
- What is the difference in climate zone for stability studies in Vietnam vs. Europe and Latin America?
- Is the fast track registration process possible for my products in Vietnam and what to be aware of?
- What are the pharma/prescription drug registration costs and time in Vietnam?
- How many trademarks should be suggested to the DAV and why?
- How can my own company be MAH in Vietnam for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in Vietnam?
- How to register Herbal and Phyto OTC drugs through DAV via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in Vietnam?
- Is a fast track registration process available in Vietnam and what to make sure of?
- What is the difference between Medical Device registration and definition in Vietnam vs. Europe, North America and throughout Latin America?
- Is my product considered a Medical Device by the laws of the MOH/DMEHW?
- What are the important differences in trademark registration in Vietnam with regards to the MOH for Medical Devices?
- Are local clinical trials necessary in Vietnam?
- Can my company act as a MAH in Vietnam?
- Climate zone for stability studies in Vietnam
- Is a fast track registration process available in Vietnam and what to be aware of?
- How difficult is the registration of Medical Devices in Vietnam?
- What are the Medical Devices registration costs and time in Vietnam?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in Vietnam with the Vietnam Food Administration?
- Why trademark registration in Vietnam can be a very difficult task with the Vietnam Food Administration?
- Can my company act as a MAH in Vietnam for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in Vietnam?
- How difficult is the registration of Food Supplements/Nutraceuticals in Vietnam?
- What are the Food Supplements/Nutraceuticals registration costs and time in Vietnam?
- How to register claims in Vietnam for Cosmetics with the DAV?
- Why is the trademark registration for Cosmetics and Derma products a big topic in Vietnam?
- Can my company act as a MAH in Vietnam or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in Vietnam?
- How difficult is the registration of Cosmetics in Vietnam?
- What are the Cosmetics registration costs and time in Vietnam?