A new scheme for verification of the quality, safety and efficacy of medical devices has been launched
by the Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) to help Indian products gain a bigger share of the global market.
The scheme, called the ICMED 13485, will be an end to end quality assurance scheme for the medical devices sector in the country, per an official release of the Commerce & Industry Ministry.
“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. This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements,” the release stated.
The initial ICMED Scheme was launched for Certification of Medical Devices in 2016.
The new scheme provides the much-needed institutional mechanisms for assuring product quality and safety.
“The launch of ICMED Plus is a watershed moment. Coming, as it does, in the aftermath of the Covid-19 pandemic and at a geostrategically crucial time when the world looks beyond a few monopolistic countries, it could shepherd India to be one of the leading global manufacturers of quality medical devices,” said K L Sharma, Chair of the ICMED Steering Committee.