The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED, the Scheme that had been launched for Certification of Medical Devices in 2016. The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices. The ICMED 13485 PLUS Scheme was launched digitally on 18th June, Friday . The Chairperson, Quality Council of India graced the occasion along with other dignitaries.
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. This scheme will be an end to end quality assurance scheme for the medical devices sector in India.
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. 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.
Mr. K. L. Sharma, Joint Secretary (retd.), MoH&FW and Chair of the ICMED Steering Committee stated that ‘The launch of the 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’.
Dr. Ravi P. Singh, SG, QCI while welcoming the guests laid emphasis on the regulatory gap which existed in India prior to 2017 and how the next 23 months of transition will continue to have regulatory gaps. To fill such gaps in the medical devices Industry, it is essential that ICMED Plus scheme, be recognized as a prerequisite to show compliance by manufacturers under MDR-2017 and to reduce the load on regulators, ICMED Plus certification should be considered as deemed compliance for one year under MDR-2017.
Mr. Rajiv Nath, Forum Coordinator, AiMeD explained the details of the scheme and responded to all questions that were raised during multi-stakeholder committee meetings. He also said that ‘The need for an Indian Quality Certification System was never felt as strongly as during the current pandemic. Access to affordable and quality medical devices can be realised through ICMED Plus certification’.