(ICMED) is the first home developed international class certification scheme for the medical devices in the country – is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB).
ICMED aims to enhance patient safety, to provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers and users. This Scheme is intended for significantly elimination 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.
The Scheme has been launched with two levels of certification:
• ICMED 9000 certification which is ISO 9001 plus additional requirements;
• ICMED 13485 which is ISO 13485 plus additional requirements.