MTal says 'redundant' certification harming medical device manufacturing sector

Bengaluru: Opposing the local medical device certification scheme, ICMED plus, the Medical Technology Association of India (MTal) has said such certifications are harming the industry.

"After numerous industry consultations and the tireless efforts of CDSCO, the government launched the Medical Device Rules in 2017, which aimed to regulate the medical device ecosystem of the country. These rules effectively measure the safety, efficacy and quality of a medical device that enters the Indian market (locally manufactured and imported).

Despite having an established regulatory system in place, we are seeing that new quasi- certification schemes such as ICMED Plus are being launched which is not only redundant but confuse the budding entrepreneurs and could burden SMEs, who aim to sell their medical devices globally - to the point of despair" said Pavan Choudhary, Chairman of MTal.

MTal added that over and above if we add a redundant certification scheme, it will add more red tape. They claim that smaller domestic companies will be affected greatly as more compliance equates to higher costs.

"When the government is admirably trying to reduce the compliance burden, what is the purpose of a quasi-government certification scheme, and who does this benefit," asks Mr Pavan.

He added that this scheme has been brought about with limited understanding and has been pushed by a particular association for a long time. "There are thousands of companies in this industry and it's an SME-heavy sector," said Pavan.

"Industry will be impacted if its application and the industry will have to incur additional avoidable costs and time delays," he added.