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, the council said in a statement.
“This scheme provides the much-needed institutional mechanism for assuring the product quality and safety. It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification,” it added.
It said that this 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.
“The QCI and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED, the scheme was launched in 2016,” it said.
Adil Zainulbhai, Chairman, QCI, said that the agility of the Indian medical device manufacturers to respond effectively to the COVID pandemic encouraged the council to further design an integrated product quality framework to support the industry during these trying times.