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Indian Certification of Medical Devices (ICMED) Plus Scheme

  • The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
  • It was first launched in 2016.
  • It has been designed to integrate the Quality Management System components and product-related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
  • This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
  • This scheme will be an end-to-end quality assurance scheme for the medical devices sector in India.
  • This scheme provides the much-needed institutional mechanism for assuring product quality and safety.
  • It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
  • This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.
Tags: Current Affairs, Economics

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