भारतीय भेषज संहिता आयोग
About ICMED 9000/ICMED 13485 Certification
Quality Council of India (QCI), India’s apex quality facilitation and national accreditation body, and the Association of Indian Medical Device Industry (AIMED) signed an MoU 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.
The manufacturing facility requiring certification under this Indian Certification for Medical Devices (ICMED) Scheme is required to be certified ultimately by NABCB accredited Certification Body duly approved by the Quality Council of India, and complying with the requirements as specified under the Scheme.
Indian Pharmacopoeia Commission - Materiovigilance Programme of India (IPC-MvPI) shall be able to offer the certification under ICMED scheme for the following levels:
- ICMED 9000 - ISO 9001 requirements plus additional requirements specified under the scheme
- ICMED 13485 - ISO 13485 requirements plus additional requirements specified under the scheme
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