Posts Tagged ‘medical device’

Licenses and Product Registration in Indonesia – In Indonesia the National Agency of Drug and Food Control (NA-DFC) is responsible for regulating pharmaceuticals products and drugs in Indonesia. Primary functions of NA-DFC include pre-market evaluation of medical products, legislation, regulation, standardization, and GMP certification. 

The criteria and guidelines for registration in Indonesia were last updated in 2011. It is based on assessment of the drug’s risk, quality, safety and efficacy and need of people. The drug registration application in Indonesia can only be done by pharmaceutical companies located in Indonesia through a pre-registration process, which takes around 40 working days. It involves consultation on completeness of registration dossier and document and registration fees.


Medical Device Registration in IndonesiaRegulatory authority: In Indonesia, medical devices are regulated by the Directorate General of Pharmaceutical and Medical Devices under the Ministry of Health (MOH). Medical products, whether they are manufactured or imported into Indonesia, must be registered with the MOH.

Classification: Medical devices in Indonesia are divided into three classes (I, II and III) based on risk level, with Class I being the lowest risk and Class III the highest risk.

To register a medical device, a company must have an office or a local distributor in Indonesia registered with the MOH.

Timeframe of registration: Medical devices are registered according to class within 30, 60, or 90 working days after the pre-registration process is complete.

Length of license: Licenses issued in Indonesia expire within 2-5 years, depending on the period of the Letter of Authorization. 

Feel free to contact us and get a free quotation for Product Registration in Indonesia


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