Medical device distribution in Indonesia
Only registered medical devices may be distributed in Indonesia, which means that the product has been issued with a Distribution Approval Number or NIE (Nomor Izin Edar) otherwise known as the Product Approval License from the Ministry of Health via the Kemenkes Online Medical Device Registration platform unless exempted from registration. All medical devices and household health supplies (PKRT) that are in circulation (i.e., registered) in Indonesia as well as those that are exported are listed in the Medical Device & PKRT E-Report system. Registered medical devices can only be distributed by companies who have a medical device distributor license in Indonesia, known locally as a SDAK.
Who can distribute medical devices in Indonesia?
What are the requirements for distributing medical devices in Indonesia?
Advertising, communication and promotion of medical devices is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. In Indonesia, advertisements of medical devices require prior approval by the MoH. The advertisement must meet the rules in accordance with Health Law No. 36 of 2009, namely objective, honest or true, complete, not misleading, not excessive and clear.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs in Indonesia to:
How Andaman Medical can help with distributing medical devices in Indonesia:
We are a fully licensed Local Authorized Representative, Importer and Distributor of medical devices, in-vitro diagnostics, medical equipment, software as a medical device (SaMD) and household health supplies (PKRT) in Indonesia. We remain independent from any final distribution channel partner you choose to appoint ensuring you freedom in your distribution strategy, you may even appoint multiple sub-distributors. Our regulatory affairs specialists will help you to: