The Indian Certification of Medical Devices Scheme (ICMED), Indias first quality assurance system for medical devices & a joint initiative of the Association of Indian Medical Device Industry (AIMED), Quality Council of India (QCI) and National Accreditation Board for Certification Bodies (NABCB), was launched on March 15 in the presence of luminaries from government, healthcare industry, etc.

Additionally, Hindustan Syringes & Medical Devices Ltd (HMD), makers of Dispo Van, is the first Indian manufacturer to get ICMED.

ICMED – Key Takeaways

Will establish news standards for device/patient safety for consumers

Will provide much-needed product credentials to manufacturers

Will eliminate trading of substandard products of doubtful origins

Will fill the big regulatory void witnessed earlier due to lack of India-specific quality assurance system that led to loss of competitiveness to foreign companies

Key Objectives

To bring down the substantial time and cost-run to obtain globally accepted quality certification for Indian companies

To eliminate the malpractices of substandard or fraudulent certification or quality audits, thereby ensuring substantial savings, enhanced credibility and increased competitiveness.

Options for Certification

ICMED 9000 Certification (an ISO 9001 plus additional requirements) for low-risk medical devices

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 the National Health Systems Resource Centre (NHSRC) of the Ministry of Health & Family Welfare is still under development and would be launched later this year.

Key Parameters to be Followed

Need to approach any one of the certification bodies approved by the 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 according to the applicable international standards.

Open to both indigenous and foreign manufacturers though Indian manufacturers would be expected to queue up initially.

Since its a voluntary certification scheme, its initial success would ride on procurement agencies demanding for this as a qualifying criterion. Dispo Van

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