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QCI launches ICMED Plus scheme with new features


The Quality Council of India (QCI), and Association of Indian Manufacturers of Medical Devices (AiMeD) have added new features to the Indian Certification for Medical Devices (ICMED) Scheme. This had been launched in 2016. The new scheme called, ICMED 13485 Plus, will undertake verification of the quality, safety and efficacy of medical devices.

The scheme 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 will be an end to end quality assurance scheme for the medical devices sector in India.

This scheme provides 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.

K L Sharma, Joint Secretary (retd), MoH&FW and chair of the ICMED Steering Committee stated, “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.”

In a statement, Jitendar Sharma, MD, AMTZ, Andhra Pradesh said, “COVID pandemic has reiterated the need to strengthen the healthcare system in the areas of quality assurance and patient safety. ICMED Plus will help in assuring the quality in medical devices.” He advocated integration of work of various regulators which impinge on the quality of medical devices sector and stressed that while pharmaceuticals are regulated in India, medical devices were not regulated till 2017.

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Girdhar Gyani, SG, Association of Healthcare Providers (India) indicated that the AHPI will encourage implementation of ICMED Plus among its members and stake holders’. “Many organizations around the world have succeeded by reducing regulatory compliance through voluntary efforts. It would be in the interest of India manufacturing sector, if the DCGI starts using certification bodies for verification of compliance in the medical devices,” he added in his statement.

Bejon Misra, Founder, Patient Safety and Access stated that the launch has demonstrated a 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 the best practices for medical devices and enhancing the value for the end users.

During the launch of the schemes, Adil Zainulbhai, Chairman, QCI, commented that ‘The agility of the Indian medical device manufacturers to respond effectively to the COVID pandemic encouraged the 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.

Ravi P Singh, SG, QCI laid emphasis on regulatory gap which existed in India prior to 2017 and how the next 23 months of transition will continue to have regulatory gaps.



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