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Indian Certification for Medical Devices (ICMED) Scheme

To fill the regulatory vacuum in quality certification space for medical devices in the country, the 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) is rolling out a voluntary quality certification scheme for medical devices.

The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

List of Consultants trained on EU Medical Device Directives and Related Regulations

Certification Criteria

The industry is expected to implement one or more of the following criteria documents for certification.

Certification Process

Requirements of Certification Bodies

Provisional of Certification Bodies

Registration of Certification Bodies

It also 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.

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

For more information please write to icmed@qcin.org