Overview Indonesia, the world's largest island country, has initiated universal health care for their citizens in 2014. This has greatly influenced the growth of medical devices market and lead to the rise in their import. Medical Devices in Indonesia are regulated by National Agency of Drug and Food Control (NADFC) functioning under Indonesian Ministry of Health (MOH). The latest regulation in place for import of Medical Devices is Decree No. 62 imposed in the year 2017. The current regulation, classifies the devices as A, B, C and D based on risk, and requires the manufacturers to appoint a local representative with a Distributor License. But, the country has a history for being dynamic in changing regulations periodically. Freyr’s team of experts keep a track of changing trends and regulations, and help the stakeholders in maintaining Regulatory compliance throughout the product life cycle. We offer Regulatory solutions to maintain other Regulatory aspects of compliance within the constrained budgets. Indonesia Market Entry for Medical Devices - Process Flow Freyr Expertise Regulatory Guidance for Registration Medical Device Classification Indonesian Local Representation Document Compilation and Application Post-Market Surveillance Summary S. No Regulatory Parameter Indonesia 1 Regulatory Authority National Agency of Drug and Food Control (NA DFC) 2 Regulation No. 62 / 2017 3 Risk Classification Class A Class B Class C Class D 4 Regulatory Pathway Marketing License Application 5 Authorized Representative Indonesian Agent Required 6 Fee payable Class A $105* Class B $210* Class C $210* Class D $350* 7 QMS Requirement ISO 13485 8 Assessment of Technical Data NA DFC 9 Validity of License 5 Years 10 Labelling Requirements No. 62 / 2017 11 Submission format Online/Paper 12 Final Outcome Marketing License with Number 13 Timelines 6 - 9 Months 14 Language English & Indonesian *The price is as per records at the time of documentation and is subject to change.