Indonesia Medical Device Labeling

Overview of medical device labeling requirements

Decree No. 62, 2017, which went into effect in 2018, is the regulation that outlines medical device labeling requirements in Indonesia. Your Local Authorized Representative (LAR) will be responsible for ensuring your device labeling complies with local regulations.

The label, which is affixed to the device itself or its packaging, can be applied after your device is imported to Indonesia but before distribution. The label can be composed of text, pictures, symbols, or graphics and must convey the following information:

• License number
• Trade Name/Brand name
• Type
• Name and address of manufacturer
• Name and address of distributor
• Batch number/lot number/serial number
• Symbols, including sterilization method used
• Product specifications
• Marking plate (if any)
• Composition and percentage (if any)
• Warning signs (if any)
• Side effects (if any)
• Expiry date (if any)

Labeling must be translated to Bahasa Indonesian, particularly essential safety information, such as warnings, side effects, and contraindications.

Instructions for Use translation requirements

Labeling in Indonesia comprises Instructions for Use (IFU), a detailed document included with the device that explains critical safety information, such as how to operate the device and its intended use. Prepare Bahasa Indonesia labeling and IFU to meet the applicable Ministry requirements, particularly instructions, warnings and other safety information. Do not rely on the historical 2020 transition as a current exemption. Any permitted supplemental-label arrangement should be confirmed for the actual authorization and device before supply.

Advertising requirements for medical devices in Indonesia

Indonesia enforces restrictions and requirements for advertising medical devices according to Regulation Number 76 of 2013 about Advertisements for Medical Devices and Household Health Supplies. Advertising to the general public is mainly allowed for low-risk/home-use medical devices.

Artwork review before supply

Use current Ministry registration instructions to reconcile the approved product name, model, licence number and local holder with each packaging level and IFU. Where local labeling is completed after import, confirm the permitted arrangement and release control before distribution rather than assuming every product has an unrestricted relabeling period.

For software, ensure the version, intended medical function, operating environment and limitations match the technical file. A change to a diagnostic claim can affect classification and registration as well as artwork. For electronic instructions, obtain a device-specific assessment of eligibility and user access; a QR code does not by itself establish compliance.

Assess halal certification and origin-of-material information separately under the current rules and product scope. The postmarket requirements guide covers change control and ongoing local-holder coordination. Retain translation review, approval dates and a controlled master so that distributors use the same approved safety information.

For regulatory terminology and the authority framework, see the Indonesian Ministry of Health.