Medical device distribution in Vietnam
Only registered medical devices may be distributed in Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate also known as the Product License unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.
Who can distribute medical devices in Vietnam?
- Only Vietnamese companies that hold a valid Establishment License may distribute medical devices in Vietnam.
- What is important to remember is that multiple distributors may be appointed in Vietnam. Even though a company must have a valid Establishment License to distribute, this same company does not necessarily have to be the Product License Holder. So, to take full advantage of having multiple distributors at a lower cost, you can appoint a Local Authorized Representative (LAR) who will register, import and act as a master distributor for your medical devices, which means that you only need to register your medical devices once. As master distributor, the LAR works alongside your final distribution channel partners to get your product to the end-user.
- If issues arise with a distributor who is also your product license holder, there is no possibility to change ownership or transfer the Product Approval License to new company. A new registration will be required, leading to higher costs and lengthy delays, especially during this period of regulatory transition towards product licenses for class C and class D medical devices ( from January 2023). Hence the advantage of appointing an independent third party or Local Authorized Representative (LAR) as the Product License Holder.
- Choosing to work with an LAR rather than directly with a distributor gives you real flexibility in your distribution strategy. This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
- It is vital to choose the correct partner as they are responsible for registering, importing and distributing your medical device to your customers or channel partners.
What are the requirements for distributing medical devices in Vietnam?
- In order to distribute a medical device into Vietnam, a company must first obtain a valid Establishment License from the Department of Planning and Investment; only Vietnamese companies can apply for an establishment license
- Distributor must also have a valid Certificate of Medical Device Trading for classes B, C and D
- The relevant product license issued by the Department of Medical Equipment and Construction of the Ministry of Health is also required prior to distribution. This is issued once the medical device has been notified or registered according to its classification.
- Class A and class B medical devices require a Notification of Applicable Standard as proof of notification prior to distribution
- Class C and class D medical devices require a Circulation Registration Certificate (Product License) as proof of registration prior to distribution
- And the valid Import License for those medical devices listed in Appendix 1, Circular 30/2015/TT-BYT; the Import License effectively has the same role as a product license and so is required for distribution purposes. (Note: the import license will be valid until 31 Dec 2022)
Advertising rules
Advertising, communication and promotion of medical device is a common part of a distribution contract. In Vietnam, the promotion and marketing of medical devices must comply with Decree 98/2021/ND-CP . Only the License Holder or those entities who are authorized by the License Holder may declare the information of the advertising content to the DMEC prior to the promotion and marketing of medical devices. The contents of promotion and advertising must be consistent with the Notification of Applicable Standard dossier of class A and class B medical devices and the Circulation Registration dossier of class C and D medical devices.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs to Vietnam to store the following quality control documents:
- Certificate of Origin
- Certificate of Quality for each batch of the medical device issued by the manufacturer
- Inspection results of medical devices (required for devices specified in Decree 98/2021/ND-CP)
- Distribution documents
Distributors must also:
- maintain a valid Establishment Licence
- a valid Certificate of Medical Device Trading for classes B, C and D if applicable
- provide appropriate storage conditions and means of transportation to maintain the safety and quality of distributed products
- have a system to monitor and manage the export, import and inventory of medical equipment containing narcotics and precursors if applicable
- maintain records of any complaints
- report any Adverse Events (AE) or other Post marketing surveillance activities to the Vietnamese Ministry of Health.
How Andaman Medical can help with distributing medical devices to Vietnam:
Andaman Medical holds a valid license to operate as an importer and master distributor of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import and distribute medical devices and IVDs. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:
- register and import your medical device
- ensure that your product registrations are valid at all times
- ensure your product is correctly labelled
- keep you abreast on the recent changes or new regulations pertaining to medical devices
- facilitate customs clearance
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors and the Vietnamese Ministry of Health concerning the mandatory reporting of Adverse Effects and other Post marketing surveillance activities.
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market