Quality Council of India (QCI), India’s apex quality facilitation and national accreditation body, and the Association of Indian Medical Device Industry (AIMED) have signed an MoU on 30 October 2014 to develop and operate voluntary certification programmes for Medical Devices in order to enable medical device industry to demonstrate adherence to the best international standards and enhance its credibility in the world market.

While QCI and AIMED are the joint Scheme owners, the governing structure of the initiative is under a multi stakeholder Steering Committee and the initiative would be operated on a non-profit but self-sustaining basis. It would have a defined consensus based technical criteria laid down for the medical devices which would be evaluated by competent third party certification bodies like MTIC.

The manufacturing facility requiring certification under this Indian Certification for Medical Devices (ICMED) Scheme is required to be certified ultimately by an NABCB accredited Certification Body duly approved by the Quality Council of India, as the joint Scheme owner, and complying with the requirements as specified under the Scheme.

The “QCI – AIMED Voluntary initiative on medical devices” here in after known as Indian Certification for Medical Devices (ICMED) Scheme, comprises of specific additional requirements that the certification bodies need to fulfil in order to be accredited by NABCB for the ICMED Scheme operated by the Quality Council of India.

MTIC India has been accredited by QCI under ICMED Scheme shall be able to offer the certification for the following levels:

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 “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, MTIC will issue a certificate and add your company name to a public accessible database so that your customers and distributors can verify.

CDSCO

The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.

MTIC is one of the Notifying Body in INDIA with CDSCO under MDR, 2017

Kindly contact for More Information on CDSCO licensing activities