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.

Certification Criteria

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

• ICMED 9000
• ICMED 13485
• Labelling Checklist - Requirements for Medical Devices – for ICMED 9000 and ICMED 13485

Certification Process

• QCI AIMED Certification ProcessRequirements of Certification Bodies
• QCI AIMED Requirements for CBs Provisional of Certification Bodies
• ICMED Application From for CBs
• QCI AIMED Provisional Approval of CB
• Revised Policy on ICMED Certification – 22.05.2016

Registration of Certification Bodies

• Approved Certification Bodies
• Applicant 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 [email protected]