India is one of the largest markets for medical equipment and supplies in the world. It is also one of the most preferred destinations for medical tourism and a significant share of medical devices used in India are imported. Medical device manufacturers are aggressively seeking market share in India considering the increasing global competitiveness and the demand for imported devices in India. Medical device importers may have the best device, but without the right regulatory strategy and regulatory experts, the device may never help any patient in India. It is the responsibility of the regulatory experts to obtain market approval through the least cumbersome approach. Slight delay in market approval means significant loss in market share and revenue generated. Lack of regulations for medical devices in India adds to the perplexity of not only how to register your device in India, but also if your device even needs registration.

Central Drugs Standard Control Organization (CDSCO) regulates the standards for medical devices and regulatory measures in India. Medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules 1945. Medical devices are defined as, “devices which are intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals as may be specified from time to time by the Central Government by notification in the Official Gazatte, after consultation with the board.”Approval from one of the GHTF countries is necessary to apply for registration in India. Medical device manufacturers need a “No Objection” certificate to legally import and sell devices in India.

Only notified devices require registration in India. The registration applications are submitted to CDSCO along with an application for an import license. It takes anywhere from 9 months to 12 months to obtain market approval in India. Manufacturing facility inspection is not required. Once the market approval is granted, the license is valid for 3 years from the date of issue. Depending on the type of medical device and its predicate, CDSCO may require local clinical testing. This is determined during the application review process. CDSCO believes clinical trials are the basis for introducing better drugs, devices and medical practices, therefore, it ensures removal of ambiguity from the existing regulations.

Due to the uncertainty with the medical device regulations in India, the key lies in finding the right experts with the in depth knowledge to obtain timely market approval in the first round of submission.

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