Quality Council of India (QCI), India’s apex quality facilitation and national accreditation body, and the Association of Indian Medical Device Industry (AIMED) have signed an MoU on 30 October 2014 to develop and operate voluntary certification programmes for Medical Devices in order to enable medical device industry to demonstrate adherence to the best international standards and enhance its credibility in the world market.
While QCI and AIMED are the joint Scheme owners, the governing structure of the initiative is under a multi stakeholder Steering Committee and the initiative would be operated on a non-profit but self-sustaining basis. It would have a defined consensus based technical criteria laid down for the medical devices which would be evaluated by competent third party certification bodies like Intertek.
The manufacturing facility requiring certification under this Indian Certification for Medical Devices (ICMED) Scheme is required to be certified ultimately by an NABCB accredited Certification Body duly approved by the Quality Council of India, as the joint Scheme owner, and complying with the requirements as specified under the Scheme.
The “QCI – AIMED Voluntary initiative on medical devices” here in after known as Indian Certification for Medical Devices (ICMED) Scheme, comprises of specific additional requirements that the certification bodies need to fulfil in order to be accredited by NABCB for the ICMED Scheme operated by the Quality Council of India.
Intertek, provisionally approved by QCI under ICMED Scheme shall be able to offer the certification for the following levels:
a) ICMED 9000 - ISO 9001 requirements plus additional requirements specified under the Scheme
b) ICMED 13485 - ISO 13485 requirements plus additional requirements specified under the Scheme
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