The Ministry of Commerce and Industry on 18th June 2021 has added features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016.
The new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices and the scheme is now launched digitally.
The scheme – ICMED 13485 PLUS – has been designed to integrate the quality management system components and product-related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
Further, the scheme will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.
