Indonesia Medical Device Regulations

Indonesia medical device regulatory framework

Medical devices sold in Indonesia are regulated by 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 MoH on their behalf.

The regulatory framework in Indonesia is shaped by several regulations and directives:

• Regulation No. 62 of 2017 is an important product-authorization reference; apply it together with subsequent health-sector, risk-based licensing and product-specific measures.
• 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

The filing scope depends on class, product type and the readiness of the evidence and local establishment. 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.

Review the applicable free-sale and overseas authorization evidence for the selected product and route. The issuing authority, manufacturing country, scope and validity must match the current Ministry checklist; do not assume any foreign approval is interchangeable.

Key resources for Indonesia medical device registration

As you begin the Indonesia registration process, here are some helpful links:

• ASEAN
• ASEAN Medical Device Directive
• ASEAN CSDT Guidance

Separate the product permit from establishment licensing

Identify the licensed Indonesian entity responsible for the application, distribution and regulatory communications. Product authorization and the establishment's business/distribution permissions answer different questions. Confirm the current licence terminology, activity scope and distribution-practice obligations in the Ministry registration system and applicable business licensing services.

Create one controlled model list and evidence index covering classification, intended purpose, manufacturer and sites, authorization letter, CSDT, testing, clinical/performance evidence, quality-system documentation and Bahasa labeling. Assess software and AI products against current product-specific Ministry guidance rather than relying on a 2017-only checklist.

Before appointing the holder, agree access to the submitted dossier, certificates, complaint records and renewal calendar, together with the procedure and cost implications if representation changes. Check the issued permit's expiry instead of assuming a universal five-year term. Plan changes and vigilance before commercial supply.