INDIAN CERTIFICATION OF 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.
Presently, the Scheme is operational through approved certification bodies (CBs) for the following levels:
ICMED 9000 certification, which is ISO 9001 plus additional requirements
ICMED 13485 certification, which is ISO 13485 plus additional requirements
ICMED 13485 Plus certification is an upgrade of the ICMED 13485 Scheme since it also takes care of product quality and product
certification in India.
Documents And Formats
ICMED Scheme Documents (ICMED 9000, ICMED 13485 and ICMED 13485 Plus)
Provisional Approval Of CBs
List Provisionally Approved CBs
List of Certified Clients
List of Expired CBs
| Sl. No. | Name of CB | Date of Expiry |
|---|---|---|
| 1 | SGS India Pvt. Ltd | 21 August 2023 |
Media Coverage
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