Overview India is counted as one of the top global Medical Devices markets with its major share towards Device imports. The country’s agency for device regulation, Central Drug Standard Control Organization (CDSCO) headed by Drug Controller General of India (DGCI) classifies Medical Devices into four classes (A, B, C and D) according the latest regulation. As the government introduces new regulations to give a fillip to the industry, entering the Indian Medical Device market seems a bit challenging. There is a need for local representative for marketing the devices in the country. The approval authority is shared between Center Licensing Authority (CLA) and State Licensing Authority (SLA). Without a detailed knowledge of updated regulations, the applicant may face ambiguity, which in turn leads to time and revenue losses. With a dedicated global delivery and operational centre in India, Freyr offers extensive knowledge on the local Regulatory landscape. With a well-paved Regulatory strategy, Freyr provides end-to-end Regulatory services for pre- and post-marketing purposes of Medical Devices. India Market Entry for Medical Devices - Process Flow Freyr Expertise Medical Device Classification Indian Authorized Agent Representation Documents Compilation Regulatory Assistance for Form MD-14 Application Liaison with Local Health Authority Post-Market Surveillance Summary S. No Regulatory Parameter India 1 Regulatory Authority CDSCO 2 Regulation Medical Device Rules, 2017 3 Risk Classification Class A Class B Class C Class D 4 Regulatory Pathway Application for Import License in MD - 14 5 Authorized Representative Indian Authorized Agent (IAA) required 6 Fee payable Class A $1,050* Class B $3,000* Class C & D $4,500* 7 QMS Requirement Schedule 5 of MDR 2017 ISO 13485 ` 8 Assessment of Technical Data CDSCO 9 Validity of License Unlimited 10 Labelling Requirements Chapter VI of MDR 17 Legal Metrology Act 11 Submission format Online 12 Final Outcome Import License in Form MD 15 13 Timelines 6-9 months 14 Language English *The price is as per records at the time of documentation and is subject to change.