India’s Medical Device Industry Develops Med-Tech Certification

India’s Medical Device Industry Develops Med-Tech Certification

The Indian Certification of Medical Devices Scheme (ICMED), the country’s first domestically developed quality assurance system, was launched on March 15 to coincide with World Consumer Rights Day. This initiative was the joint effort of the Association of Indian Medical Device Industry, the Quality Council of India, and the National Accreditation Board for Certification Bodies (NABCB).

NABCB’s certification programs are considered on par with international equivalents, especially European and U.S. accreditation bodies, chief executive officer Anil Jauhri said during the launch.

The certification aims to enhance patient safety and consumer protection along with product credentials for Indian manufacturers for instilling confidence among buyers and users. It also aims to eliminate trading of sub-standard products or devices of doubtful origin, reports Medical Devices Daily.

The certification currently offers two options:

An ICMED 9000, on par with ISO 9001 with additional requirements and is aimed at low-risk devices

An ICMED 13485, on par with ISO 13485 with additional requirements and applies for medium- to high-risk devices.

A third level of certification, which will additionally provide medical device specifications for specific products, is being developed by the National Health Resources Research Center under India’s Ministry of Health and Family Welfare.

India still imports 70 percent of its medical devices and 40 percent of the imports are from the U.S. alone.


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