India: New Guidelines for Import and Manufacture of Medical Devices in Effect

The import and manufacture of medical devices in India is now regulated by guidelines issued by the Drug Controller General of India (DCGI). New medical device guidelines, which went into effect on March 1, 2006, outline the procedures and requirements for importing and manufacturing 10 selected sterile medical devices. These 10 devices, classified as drugs in notification S.O. 1468(E) (October 2005), are: cardiac stents, drug-eluting stents, catheters, intra-ocular lenses, IV cannulae, bone cements, heart valves, scalp vein sets, orthopedic implants, and internal prosthetic replacements.

According to the new medical device regulation, all importers of these devices are required to apply for import licenses and file product registrations with the DCGI. The application submission must include such documentation as the master file, detailed product information, post-market surveillance procedures, biocompatibility, and safety and quality system standards that the device conforms to. The application should also include the device’s regulatory status in other countries, such as U.S. FDA approval or CE certificates, as well as other countries where the device is being sold. If the device has been withdrawn from any country, the applicant should also provide this information along with an explanation. In addition, expert committees will also be convened to evaluate specific categories of devices. These committees will develop evaluation benchmarks as well as standards that the devices should conform to.

Manufacturers of the selected devices must apply for manufacturing licenses from the State Licensing Authority (SLA). The application for a manufacturing license must include details about the manufacturing process, including the site master file, description of the manufacturing process, Good Manufacturing Practice (GMP) standards, and copies of ISO or other certifications. The application should also include detailed product information. Any new medical device or device that does not have benchmark certification would first be evaluated by an expert committee, which would make a recommendation to the SLA. The SLA, following Joint Inspection and verification of the recommendation, would then forward it to the Central Licensing Approval Authority for approval.

All importers and manufacturers of these medical devices are required to file applications for the necessary licenses within 60 days after the March 1 st 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.