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INDIAN CERTIFICATION OF MEDICAL DEVICES PLUS (ICMED) SCHEME

INDIAN CERTIFICATION OF MEDICAL DEVICES PLUS (ICMED) SCHEME

Context:

Association of Indian Manufacturers of Medical Devices (AiMeD) and Quality Council of India (QCI) and have launched the “Indian Certification of Medical Devices Plus (ICMED) Scheme”.

About:

  • The ICMED 13485 PLUS, as the new scheme has been initiated, will embrace checks of the quality, security and efficacy of medical devices.
  • ICMED 13485 Plus has been designed to incorporate the Quality Management System parts and product-related quality approval measures through witness testing of items concerning the characterized item guidelines and particulars.
  • This is the 1st scheme around the globe in which quality management systems along with product certification standards are incorporated with regulatory requirements.
  • This scheme will be an end to end quality affirmation scheme for the medical devices sector in India.
  • The scheme will help procurement agencies to handle challenges identified with fake products and fake certification.
  • It will likewise dispense circulation and use of sub-standard medical products or devices of doubtful origin.

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