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?
- Typically, a distributor’s license or equivalent will be required in order to distribute medical devices
- Only locally registered companies will be able to apply for a distributor’s license, which means that foreign manufacturers either have to establish their own subsidiary office OR appoint a Local Authorized Representative (LAR) who can act as a master distributor working alongside nominated distributors concerning regulatory aspects
- Some countries require distributors to have Good Distribution Practice for Medical Devices (GDPMD) certification or to maintain these principles
- Depending on the country, a Letter of Authorization for Distributors may be necessary either from the manufacturer or the LAR.
Distributors duties and obligations
Most countries impose mandatory duties and obligations on distributors of medical devices and IVDs such as:
- maintaining a Quality Management System such as GDPMD certification
- maintaining distribution records
- maintaining records of any complaints
- reporting any Adverse Events (AE) or Field Safety Corrective Actions to the relevant local medical device authority.
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
