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.
Gujarat Govt. has a scheme to subsidize cost of certification for any certification scheme endorsed/approved by Quality Council of India (QCI). The details are available under their website link http://www.ic.gujarat.gov.in/assistance-for-quality-certification.aspx
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 firstname.lastname@example.org
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
Requirements of Certification Bodies
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
News and Highlights
- Govt. to Create a Separate Ministry for Medical_16 Feb 2018
- QCI, AMTZ and AiMeD form Indian Bio-Medical Skill Consortium to certify capacity of Indian biomedical engineers_20 Feb 2018_Pharmabiz
- QCI, AMTZ & AiMeD launch Indian bio-medical skill consortium_20 Feb 2018_Biovoice
- AMTZ in collaboration with NABCB, AiMeD forms IBSC to strengthen biomedical engineering skill sector_30 MAR 2019_Pharmabiz