Medical device distribution
Only registered medical devices may be distributed into the 6 major ASEAN countries we cover, unless the product has been exempted from registration. Each country has its own country-specific regulations, requirements and procedures not only for registration but also for the distribution of medical devices and IVDs, it is therefore advisable to work with a local partner on-the-ground in your target country to ensure a successful market access strategy.
What are the typical requirements for distributing medical devices?
Distributors duties and obligations
Most countries impose mandatory duties and obligations on distributors of medical devices and IVDs such as:
How Andaman Medical can help with distributing medical devices:
Depending on your target country, we will act as your distributor or master distributor as well as your independent local authorized representative or marketing authorization holder. This means you can retain the freedom to appoint as many distributors or sub-distributors for your device as you require, while your product license remains unaffected by any changes in your distributor network