Medical Devices and Diagnostics

In 2005, the DCGI vide Gazette notification S.O. 1468 (E) dated 6/10/2005 has declared ten categories of sterile devices - Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I.V. Cannulae,      Bone Cements, Heart Valves, Scalp Vein Set, Orthopedic Implants, Internal Prosthetic replacements  as drugs under the Drugs and Cosmetics Act. These guidelines went into effect from 1st March 2006; a date that was later changed to June 19, 2006. The DCGI has set up separate committees for evaluation and formulation of standards for conformation, for specific categories of devices. An importer will be permitted to submit the US FDA clearance, the European Union medical device directive and similar approvals from other countries for proof of quality. For granting of licenses to locally manufactured devices with no benchmark certification, the DCGI will set up expert committees for evaluation. The State Licensing Authority (SLA) and the Central License Approving Authority will verify the recommendation of the committees. DCGI has also specified that all importers, stockists and retailers of medical devices will have to obtain sale licenses from the SLAs within a period of three months. Devices that are not imported into the country by the date of notification are not permitted without the approval of competent authority. In the case of stents (specifically drug eluting stents) imports are permitted only if the applicant has sold more than 1,000 stents of the particular specification prior to the date of issue of these guidelines. All importers and manufacturers of these medical devices are required to file applications for the necessary licenses within 60 days after the March 1st issuance of the new guidelines. In addition, any importer or retail seller of these devices must obtain the appropriate sale licenses from the SLA within 3 months after the issuance of these guidelines.