This is the first scheme around the world in which quality management systems, along with product certification standards, are integrated with regulatory requirements
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 was 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 recently, according to a statement by the Ministry of Commerce and Industry.
The statement also said that 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,” it added.
Further, it mentioned that the scheme provides the much-needed institutional mechanism for assuring 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.
Speaking in this regard, KL Sharma, Joint Secretary (retd.), Ministry of Health and Family Welfare (MoH&FW) and Chair, 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 Jitendar Sharma, MD, AMTZ, Andhra Pradesh has commented that COVID-19 pandemic has reiterated the 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, helps in assuring the quality of medical devices. He strongly advocated the integration of the work of various regulators which impinge on the quality of the medical devices sector. He also stressed that while pharmaceuticals are regulated in India, it is an irony that medical devices were not regulated till 2017 which makes for a sizable investment in the healthcare system.
Dr Girdhar Gyani, SG, Association of Healthcare Providers (India) has indicated that AHPI will encourage the implementation of ICMED Plus among its members and stakeholders. He reminded the gathering that many organisations around the world have succeeded by reducing regulatory compliance through voluntary efforts. It would be in the interest of Indian manufacturing sector if the Drugs Controller General of India (DCGI) starts using certification bodies for verification of compliance in the medical devices.
Professor Bejon Misra, Founder, Patient Safety and Access stated that yet another milestone has been created by QCI in providing value addition to medical devices to consumers. 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.
During the launch of the scheme, Adil Zainulbhai, Chairman, QCI, commented, “The agility of the Indian medical device manufacturers to respond effectively to the COVID pandemic encouraged QCI to further design an integrated product quality framework to support the medical device industry during these trying times. QCI will always respond effectively to the requirements of the industry and make sure that such voluntary efforts improve the regulatory requirements in the country.
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, “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.”
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