Medical device certification scheme ICMED Plus redundant for SMEs, will hurt ease of doing business: MTal

The scheme has been intended towards assisting the procurement agencies to tackle counterfeit products and fake certification challenges. (Image: Reuters)

Ease of Doing Business for MSMEs: The Indian Certification of Medical Devices (ICMED) scheme, which was rechristened as ICMED Plus in June this year to integrate the Quality Management System (QMS) components and device-related quality validation processes, is redundant and would impact the ease of doing business and investment opportunities for SMEs and other businesses, according to Medical Technology Association of India (MTal) that represents medical device and equipment industry in India.

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According to the association, the scheme has re-specified the requirements for QMS for medical devices in India which were already existing in Medical Device Rules (MDR), 2017, and ISO 13485. It maintained that the industry already takes the required regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO) but is now facing the issue of multiplicity of regulatory authorities. ISO 13485 is the standard for a QMS to design and manufacture medical devices.

“The maximum number of companies in this sector is domestic SMEs. Though the government is striving to reduce their compliance burden as well as bringing in attractive incentive schemes for local manufacturing, such a redundant scheme will most destabilize only these small local companies. These SMEs which are already crippled by the pandemic will now have to jump a needless hurdle and incur avoidable costs before coming into the market,” Pavan Choudary, Chairman & Director General, MTal told Financial Express Online.

According to Choudary, despite having an established regulatory system (MDR) in place, the “quasi- certification schemes” such as ICMED Plus will confuse the budding entrepreneurs and burden SMEs. Moreover, such certification schemes increase unpredictability, thereby decreasing the attractiveness further, as the global interests are unsure of whether or not they will have to comply with new certification schemes as they enter India, the association had maintained.

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The Commerce Ministry in a statement in June this year had noted that ICMED Plus is the first scheme in the world wherein the QMS 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.” Moreover, Quality Council of India’s (QCI) Secretary General Ravi P. Singh had said in the statement that ICEMED Plus was essential to be recognized as a “pre-requisite to show compliance by manufacturers under MDR-2017 and to reduce the load on regulators.” ICMED Plus was launched by QCI.

“ICMED Plus is voluntary product certification. Hence, there is no question of increased compliance burden for a manufacturer as he will seek it if he finds merit in it. Other countries do have voluntary certification in addition to regulations or to help regulators in reducing regulatory oversight such as European Union uses ISO/EN 13485, the US, Brazil, Canada, and Japan use MDSAP certification. The scheme allows Indian manufacturers to demonstrate compliance but on a voluntary basis as defined in India’s standards strategy launched last year in June,” Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices and Forum Coordinator, Association of Indian Medical Device Industry told Financial Express Online.

The scheme has also been intended towards assisting the procurement agencies to tackle counterfeit products and fake certification challenges along with eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that might cause health hazards. “Currently around 22-23 medical device types are regulated and certified by CDSCO. How would you be sure of the quality of the rest of the devices? While there should not be a multiplicity of regulatory bodies but ICMED in the interim will play a fantastic role. The ideal situation would be to have ICMED amalgamated within the CDSCO certification process so that is only one medical device certification process,” Professor Amitabha Bandyopadhyay, Incharge — Innovation and Incubation, IIT Kanpur told Financial Express Online.