Indonesia Medical Device Guide
Indonesia Market Access for Medical Device
REGULATORY AGENCY
- Ministry of Health Republic of Indonesia
REGULATIONS
- Marketing licensing of medical devices is required for both domestically manufactured and imported devices.
- Based on the risks that are caused during usage, medical devices are divided into four classes, namely Class I, Class IIa, Class IIb and Class III.
- Applications should be submitted to the Indonesian Director General of Food and Drugs.
- Registration application for imported devices should be accompanied with evidence that they have been officially traded overseas.
GUIDELINES
- A local representative is required for the registration of imported products.
- A registration number which should be shown on the label will be allocated once the application is approved.
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