The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the Indian Certification of Medical Devices (ICMED) 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.
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.
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.
There is a need to strengthen the healthcare system in the key areas – quality assurance and patient safety. ICMED Plus, one of the recent initiatives by the QCI, help in assuring the quality in medical devices.
ICMED Plus launch has demonstrated a strong commitment by the medical devices manufacturers in India to not only provide medical devices products to consumers in India, but also compete globally by adopting global best practices for medical devices and enhancing the value for the end users.
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.