Medical device importation to Indonesia
Only registered medical devices may be imported into Indonesia, which means only products that have 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 Online Medical Device Registration platform (hereafter called the Kemenkes system) unless exempted from registration (see below). All medical devices and household health supplies (PKRT) that are in circulation in Indonesia as well as those that are exported are listed in the Medical Device & PKRT E-Report system.
What are the requirements for importing medical devices into Indonesia?
Are there any exemptions or exclusions?
Special Access Routes for importing medical devices into Indonesia
Two Special Access Routes exist in Indonesia for importing medical devices which are exempt from registration with the Ministry of Health, however the SAS permit must be obtained from the MoH before importing:
1. SAS Donations only for the needs of:
2. SAS Non-Donations only for the needs of:
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Indonesia to:
How Andaman Medical can help with importing medical devices to 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 (PKR) 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 distributors. Our regulatory affairs specialists will help you to: