With a view to boost confidence of industry, the Association of Indian Medical Devices Industry (AIMED) recently entered into memorandum of understanding (MoU) with National Accreditation Board of Certifying Bodies (NABCBs) and Quality Control of India (QCI). Through this initiative which is also done with the support of the commerce ministry, the association plans to build trust in Indian medical devices in terms of credibility and reliability, in lines with best international practices and standards worldwide.
Most importantly, this move aims to bring in some regulatory semblance within the sector in the wake of absence of an appropriate regulatory framework in the country. The association believes that this self certification initiative will help in setting much needed standards for the industry, which the sector has been time and again demanding to the government.
Rajiv Nath, forum coordinator of AIMED informed that while details need to be worked out by the steering committee, the basic vision and strategic plan is to have a non corrupt professional system, whereby competent confirmatory assessment bodies (CABs) in India accredited by NABCB or IAF will provide low cost self certification to access Indian manufacturers for ISO 13485 / BIS 15579 certificates for medium and high risk devices.
He further informed that this move will change and bring in a paradigm shift for the market of 10 medical devices notified as drugs since 2005, which still continues to be incorrectly and incompletely regulated. Industry experts alleged that in spite of repeated representation to the centre, the government has hardly made any move to address the issues of the industry in a progressive way.
He pointed out, “Since the ministry of health and CDSCO seem to be in no rush to correctly and appropriately regulate the industry, the industry felt the need to do so. This will enable the Indian industry not only to demonstrate their quality in India but also prepare them for CE marking and facilitate exports if they are interested.”
It is understood that audit will be done only by trained, certified, competent experts accredited by these CABs, with special focus on compliance to the essential principles of patient safety (GHTF). Also, they would ensure compliance to labelling requirements for consumer protection.
"So far Indian companies had to rely on foreign certifying bodies like Intertek, TUV, BSI etc to certify their plants if they wished to export to Europe or other countries. Through this initiative we will now provide a platform of low cost but a reliable and trustworthy certification that will enable Indian patients and procurement and healthcare providers have trust in medical device industry certified by locally available auditing companies," Nath concluded.