Indian Certification for Medical Devices (ICMED) 13485 Scheme

 

UL is a Certification Body under ICMED

Regulation of medical devices and their quality systems in India has been limited when compared to other developed nations that typically have very robust medical device approval systems in place.

To help address this gap, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) established a voluntary quality certification scheme for medical devices in India, ICMED 13485.

The program is based on the international harmonized quality management system standards with additional requirements specific to the India market.

  • ICMED 13485 – Based on the International Harmonized Standard (ISO 13485) “Quality Management Systems for Medical Devices” plus additional requirements specified under the scheme.
  • ICMED 9000 – Based on the International Harmonized Standard (ISO 9000:2008), “Quality Management Systems.”

Who can apply?

  • Indian medical device manufactures/ exporters
  • Local authorized representatives of medical device manufactures/ distributors

Benefits of ICMED ISO 13485 registration

  • Establish brand confidence of medical devices manufactured in India
  • Enhance patient safety
  • Provide healthcare users with quality medical devices manufactured in a certified facility

Deliverables

Upon successful completion of the program, UL will issue a certificate and add your company name to a public accessible database so that your customers and distributors can verify.

For more information and queries, contact us

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