India is counted as one of the top global Medical Devices markets with its major share of Device imports. The country’s agency for device regulation, the Central Drug Standard Control Organization (CDSCO) headed by the Drug Controller General of India (DGCI) classifies Medical Devices into four classes (A, B, C, and D) according to 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 representatives for marketing the devices in the country. The approval authority is shared between Center Licensing Authority (CLA) and State Licensing Authority (SLA). Without 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 center in India, Idalius Medical Consulting Services offers extensive knowledge on the local Regulatory landscape. With a well-paved Regulatory strategy, Idalius Medical Consulting Services provides end-to-end Regulatory services for pre-and post-marketing purposes of Medical Devices.