MOH Indonesia Medical Device Registration

Medical devices and IVDs sold in Indonesia are regulated by the Ministry of Health (MoH). All devices must obtain market authorization by registering with the MoH and receiving a Product Registration License (NIE). Manufacturers also need a Medical Device Distribution License (IDAK/MDDL). Foreign manufacturers are required to appoint a Local Authorized Representative (LAR) to submit the registration application and maintain regulatory compliance on their behalf.

Indonesia’s regulatory framework follows Regulation No. 62 of 2017, the ASEAN Medical Device Directive (AMDD), and Global Harmonization Task Force (GHTF) guidance. Submissions must follow the ASEAN Common Submission Dossier Template (CSDT) format.

MoH Indonesia medical device regulatory pathway

All medical devices and IVDs must be classified and submitted for registration according to their risk level. Devices are classified into four risk classes: Class A, B, C, and D.

Indonesia Medical Device Registration Process (All classes of medical devices and IVDs)

• Process: Applications are submitted via the MoH’s online portal using the ASEAN CSDT format. Devices must have home country approval or authorization in a GHTF member country.

• Documentation requirements: A complete submission includes ISO 13485 certification, clinical data, test reports, labeling in Bahasa Indonesia, translated Instructions for Use (IFU), and a Certificate of Free Sale. Higher-risk devices (Classes C and D) require more extensive data to demonstrate safety and effectiveness.

• Distributor licensing: Foreign manufacturers must appoint a Local Authorized Representative (LAR) or establish a local entity to obtain a distributor license (IDAK/MDDL).

• Timeline: The registration review process is relatively efficient, provided that all documents are complete and accurate.

• Renewal: Device licenses are valid for five years and must be renewed proactively. Renewals should begin at least nine months before expiration.

Other MoH registration requirements

• In-country representation: All foreign manufacturers must appoint an LAR to manage interactions with the MoH, ensure compliance, and submit regulatory documentation. The LAR is also responsible for labeling compliance, vigilance reporting, and importation.

• Translation: Labeling and IFU must be fully translated into Bahasa Indonesia. Essential safety information must always be provided in Bahasa, including for legacy products. New registrations must include translated IFU at the time of submission.

• Labeling requirements: Labels must be provided in Bahasa Indonesia and affixed after import but before distribution.

• Other certification requirements: Medical devices that contain animal-derived or biological materials must obtain halal certification. The certification process includes a manufacturing site inspection by an agency recognized by Indonesia’s Halal Product Assurance Organizing Body (BPJPH).

• Modifications: Minor changes to labeling, packaging, device configuration, or manufacturer/distributor details can be submitted as modifications. Substantial changes may require a new registration. Modifications and renewals can be submitted concurrently.

• Post-market obligations: Companies must monitor product performance and comply with postmarket surveillance and vigilance requirements.

What documentation is required to register a medical device or IVD in Indonesia?

A complete regulatory submission in Indonesia includes:

• ASEAN CSDT format dossier

• ISO 13485 certificate

• Clinical data and test reports

• Labeling and IFU translated into Bahasa Indonesia

• Certificate of Free Sale or GHTF market authorization

• Appointment of a Local Authorized Representative (LAR)

• Device classification and grouping information

Additional documents may be required depending on the device class, intended use, and grouping strategy.

What is a Local Authorized Representative (LAR) and why do you need one?

Foreign medical device manufacturers must appoint a Local Authorized Representative (LAR), a legal entity based in Indonesia to hold the Product Registration License (NIE) and act as the point of contact with the MoH. The LAR must hold a Medical Device Distribution License (IDAK/MDDL) and be Good Distribution Practice of Medical Devices (GDPMD) certified. The LAR manages the entire approval process and acts as the sole importer. You can only appoint one LAR per device. The only way to transfer your device to a new LAR is to cancel your registration and reapply with a new representative.

What are the halal compliance requirements for medical devices in Indonesia?

Medical devices containing animal-derived or biological materials must obtain Halal certification from the Halal Product Assurance Agency (BPJPH). Applications must be submitted through the SiHalal portal, and include documentation such as a legalized Letter of Authorization, ISO 13485 or GMP certificate, a full list of ingredients with material origin, and translated product labels. An accredited Halal Inspection Body (LPH) conducts an audit of the manufacturing process. Compliant products receive a Halal Certificate valid for four years.

What are the deadlines for halal certification for medical devices in Indonesia?

Medical devices must obtain halal certification by the following deadlines:

• Class A: October 17, 2026

• Class B: October 17, 2029

• Class C: October 17, 2034