Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Indonesia
Indonesia is a large country in Southeast Asia with about 230 million people. Only China, India, and the United States have greater populations. To sell your drugs or medical devices on the Indonesian market, it is necessary to register them with the Directorate General of Pharmaceutical Services & Medical Devices.
The National Agency of Drug and Food Control (NA-DFC) is the main government institution responsible for regulating pharmaceuticals/drugs and medical devices. The Deputy of Therapeutic Products and Narcotics, Psychotropic and Addictive Substance control carries out pre-market evaluation on efficacy, safety and quality of drugs, biological products and medical devices. It is supported by various organizations such as the National Committee on Drug Evaluation, National Committee on Medical Devices Evaluation and Evaluation Committee on Promotion of Over the Counter Drugs, Traditional Medicines and Food Supplement.
You cannot register a drug or device in Indonesia without either a local Indonesian office or a local distributor. Therefore, if you do not plan to open your own local office, it is important to select a distributor with good regulatory capabilities.
For more information on regulatory issues in Indonesia, please see the following PBM publications and/or contact us to discuss your specific needs.
