Setting a benchmark in the industry, the Hindustan Syringes & Medical Devices (HMD) became the first Indian Certification of Medical Devices Scheme (ICMED) certified medical device company in India. With this accreditation the company has achieved a significant milestone as it brings quality, accountability and competitiveness into the system.

ICMED is the country’s first indigenous quality assurance system for medical devices that was launched recently to fill in a big regulatory vacuum in quality certification space for medical devices in India. This scheme ushers new standards for device; patient safety for consumers and the convenience of obtaining international class quality certification within the country for manufacturers, thereby ensuring significant savings and enhancing competitiveness.

Keen to enhance the competitiveness and profitability of Indian medical device industry, this initiative was jointly undertaken by Association of Indian Medical Device Industry (AIMED), Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). This Scheme is intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies and eliminate the malpractices of sub-standard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness, informed Rajiv Nath, joint managing director, HMD. He further added that in due course this scheme will also bring respect to brand India for those carrying this certificate.

Until now, there was no India-specific official quality assurance system, due to which Indian medical device manufacturers encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits, ICMED fills a big regulatory void. AIMED has termed it a significant milestone due to multiple benefits it would assure to different stakeholders.

The certification scheme has presently two options for certification, one being ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ for low risk medical devices and other being ‘ICMED 13485 (An ISO 13485 Plus additional requirements)' for medium and higher risk devices. A third level, which would additionally prescribe medical device specifications developed by NHSRC of health ministry is still under development and would be launched later this year.

"The manufacturers would need to approach any one of the certification bodies approved by QCI under the scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which as the national accreditation body, would accredit these certifying bodies as per applicable international standards. The certification scheme is open to both indigenous and foreign manufacturers though Indian manufacturers would be expected to queue up initially. Since it's a voluntary certification scheme its initial success would ride on procurement agencies demanding for this as a qualifying criteria,” said Nath who is also the forum coordinator of AIMED.