Indonesia medical device regulatory framework
Medical devices sold in Indonesia are regulated by the National Agency of Drug and Food Control (NADFC), which is a division of the Ministry of Health (MoH). All devices sold in Indonesia must be registered with the MoH and obtain a product license. Foreign manufacturers need to appoint a Local Authorized Representative (LAR) to submit the registration application and liaise with NADFC on their behalf.
The regulatory framework in Indonesia is shaped by several regulations and directives:
- Regulation No. 62 of 2017 is the most recent domestic regulation that addresses the import of medical devices.
- The ASEAN Medical Device Directive also informs aspects of Indonesia’s regulatory process, such as the ASEAN Common Submission Dossier Template (CSDT), which is the required format for registration submissions.
- The Global Harmonization Task Force (GHTF) and ASEAN classification frameworks also inform Indonesia’s classification scheme for medical devices, IVDs, and household health supplies.
Indonesia medical device registration process
Medical device registration and approval can be a quick process relative to other markets once your registration documentation is submitted. Foreign manufacturers will need to appoint an LAR or establish a local entity to obtain an IDAK/MDDL license. Registration submission requirements include clinical data, test reports, ISO 13485 certification, labeling, Instructions for Use, and other items detailed in the CSDT template documentation.
Home country approval is required. However, NADFC will also accept market authorization in a GHTF member state if you do not have home country approval.
Key resources for Indonesia medical device registration
As you begin the Indonesia registration process, here are some helpful links:
