The Indian government is unveiling a risk-based framework that governs the quality of imported medical devices into the country to improve safety standards. Randomized sampling will be required for the vast majority of imported medical devices, and only high-priority and diagnostic kits are going to be subject to testing of an entire shipment.
The government has outlined a comprehensive guideline for port officers to help them make better-informed decisions to ensure device quality at the point of import. The risk-based model determines the level of quality control according to their possible effect on public health. This new risk-based framework affirms India’s commitment to the supervision of imported medical devices (as well as drugs and cosmetics) for the protection of public health.
The new guidance outlines a three-part sampling model consisting of 1. visual assessment, 2. field testing (testing under conditions of actual use instead of in a controlled environment), and 3. full laboratory testing when required. Some public health products defined as high-priority, such as vaccines and condoms, will be fully tested to eliminate unsafe or poor-quality products from entering the Indian marketplace.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.