Devicemakers in India may soon obtain quality certification as part of an initiative launched earlier this month.
The Indian Certification of Medical Devices Scheme is the country’s first indigenously developed system of its kind.
The scheme features two options for certification – ICMED 9000 (an ISO 9001 plus additional requirements) for low-risk devices and ICMED 13485 (an ISO 13485 plus additional requirements) for medium- and high-risk devices.
A third level, which would introduce device specifications developed by the Health Ministry’s National Health System Resource Centre, will be launched later this year.
ICMED is a joint initiative of the Association of Indian Medical Device Industry, Quality Council of India and the National Accreditation Board of Certification Bodies.
The program aims to reduce the time to obtain globally accepted quality certification for Indian companies and eliminate malpractice in substandard or fraudulent certifications or quality audits.
NABCB is accrediting certification and inspection bodies and its accreditation programs are internationally equivalent, placing it on par with European and American accreditation bodies, says CEO Anil Jauhri.
“This equivalence would help facilitate acceptance of ICMED certification in overseas markets,” he says.
The certification scheme is open to both domestic and foreign manufacturers, although Indian devicemakers are expected to join initially. — Jonathon Shacat