Overview of medical device labeling requirements
Labeling requirements for medical devices are established by the National Agency of Drug and Food Control (NADFC), which is a division under the Indonesian Ministry of Health (MoH). Decree No. 62, 2017, which went into effect in 2018, is the regulation that outlines medical device labeling requirements. Your Local Authorized Representative 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. Decree No. 62 made it mandatory to translate IFU to Bahasa and allowed for a two-year grace period for manufacturers to comply. The grace period ended in 2020, but the NADFC may allow devices registered prior to the enforcement of the decree to remain on the market as long as essential safety information is provided in Bahasa, which may be included as a supplemental document. New registrations must include fully-translated labeling and IFU with their regulatory submission.
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 is only permitted for home-use products with approval from the Ministry of Health.
