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ICMED 13485 PLUS

Published on June 23, 2021
Current Context: The Quality Council of India (QCI) has launched ‘Indian Certification of Medical Devices 13485 PLUS Scheme (ICMED 13485 PLUS).
ICMED 13485 PLUS
  • It was launched to perform verification of medical devices in the areas like quality, safety and effectiveness.
  • The latest scheme is the upgraded version of the ICMED scheme which was launched in 2016 to certify medical devices.
  • The upgraded version was drafted by QCI and the Association of Indian Manufacturers of Medical Devices (AiMeD).
  • Under the scheme, quality management systems and product certification standards are integrated to have regulatory norms.
  • By integrating quality management systems and product certification standards it witnesses the testing of products by considering reference products and specifications.
  • ICMED is an end to end quality assurance scheme for medical devices and the ICMED 13485 PLUS offers an institutional mechanism to assure product quality and safety of medical devices.
  • Static Part: 
    • HQ of QCI: New Delhi
    • Chairperson of QCI: Adil Zainulbhai
    • Secretary-General of QCI: Dr Ravi P Singh
    • HQ of AiMeD: New Delhi

Question: 

Q.1 Which organisation launched an upgraded version of the ICMED scheme called ‘Indian Certification of Medical Devices 13485 PLUS Scheme (ICMED 13485 PLUS)?
a. Quality Council of India (QCI)
b. All India Institute of Medical Sciences - New Delhi
c. Association of Indian Manufacturers of Medical Devices (AiMeD)
d. Both (a) and (c)
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