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Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)

  Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place. Together with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), the Association of Indian Medical Device Industry (AIMED) has developed a voluntary quality certification scheme for medical devices in India, Indian Certification for Medical Devices (ICMED) It is the country's first indigenously developed quality assurance system mandatory for all medical devices marketed in the nation. This was proposed in a recent meeting called for the drafting of (separate) rules for medical devices with government officials with a special focus on drafting regulatory framework for the granting of medical device manufacturing licenses. The meeting discussed how to proceed with the registration of manufacturers and importers of medical devices on an...

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