Industry Moves Forward With Self-Certification Scheme

Indian devicemakers and governmental and nongovernmental partners have formed a steering committee to push forth a self-certification scheme for industry manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products.

The initiative kicked off in October with the signing of a memorandum of understanding by the Association of Indian Medical Device Industry, the Quality Council of India and the National Accreditation Board for Certification Bodies.

Under the scheme, QCI — with the help of AIMED — will identify globally accepted quality standards for categories of devices and determine their suitability for India. NABCB will provide accreditation services to conformity assessment and certifying firms that perform quality audits of manufacturers. QCI and AIMED will vouch only for those quality certificates that have been accredited by NABCB.

Rajiv Nath, forum coordinator for AIMED, says industry is “tired of the endless wait for an appropriate regulatory framework for quality certification of medical devices in the country” and ready to roll out a “world-class voluntary certification regime.” — Jonathon Shacat