Medical device distribution in Thailand
Only registered medical devices may be distributed in Thailand, that means they must be registered with the Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health and been issued with a Product License (Listing Certificate/Notification Certificate/License).
Importation depending upon their class, and unless exempted from registration. Registered medical devices can only be distributed by companies who have a license as medical device importers or manufacturers in Thailand, known locally as an Establishment License.
Who can distribute medical devices Thailand?
- Only Thai companies that hold a valid Establishment License and Product License (Listing Certificate/Notification Certificate/License) from the Thai FDA may distribute medical devices in Thailand.
- What is important to remember is that multiple medical device distributors may be appointed in Thailand. However, this will increase your initial product registration costs as each distributor must register the medical device separately because only product license holders may import and distribute your medical device.
- 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.
- Unlike the Philippines, if issues arise with your existing distributor who is also your product license holder, you cannot change ownership or transfer the Product Approval License to new company, you must register the product again, which increases the costs and time delays to be able to distribute again. 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 medical device 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 Thailand?
- In order to distribute a medical device in Thailand, a company must have a valid Establishment License;
- A company must have the product’s valid Listing Certificate/Notification Certificate/License.
Advertising rules
Advertising, communication and promotion of medical device is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. In Thailand, advertisements, promotion and marketing of medical devices should comply with Medical Device Act BE2551. Prior to advertising in any platform (radio, TV, digital media) medical devices, an advertisement permit must first be obtained from the Thai FDA.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in Thailand to:
- to report medical device problems including device defects or Adverse Effects (commonly known as Adverse Events AE) and Field Safety Corrective Actions (FSCA) to the Thai FDA
- provide appropriate storage conditions to maintain the safety and quality of distributed products
- maintain distribution records
- hold valid Good Distribution Practice for Medical Devices (GDPMD) certification or Quality Management System
- maintain a valid Establishment License
- make sure that products are properly labelled prior to market distribution.
How Andaman Medical can help with distributing medical devices in Thailand:
Andaman Medical holds an Establishment License to operate as an Importer of medical devices, IVDS, medical equipment and Software as a Medical Device (SaMD) in Thailand. 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 will help you to:
- register and import your medical device
- ensure your product is correctly labelled
- facilitate customs clearance
- maintain post-market surveillance of your registered product
- liaise with your appointed distributors and the Thai FDA concerning the mandatory reporting of Adverse Effects and Field Safety Corrective Actions
- keep you abreast on the recent changes or new regulations pertaining to medical devices.
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.