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Indian Certification for Medical Devices Scheme (ICMED)

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certification process

Certification Process

Application Form

ICMED certification fees

Transition policy for ICMED Scheme's

What is ICMED Scheme?

In order to enhance patient safety,  provide enhanced consumer protection, eliminate trading of sub-standard products or devices of doubtful origins, independent third party voluntary certification system to assure quality of medical devices manufactured in the country  has been rolled out.

The Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB)  in collaboration with the Association of Indian Medical Device Industry (AIMED) have rolled out a voluntary quality certification scheme for medical device industry in the country.

The Scheme has been launched with two levels of certification:-

  • ICMED 9000 certification which is ISO 9001 plus additional requirements
  • ICMED 13485 which is ISO 13485 plus additional requirements

Why is icmed certification scheme Important?

With the recent announcements from Indian government for focusing “Atma Nirbhar Bharat” self-reliant India, emphasis is on Indian products. Indian medical device industry is required to  fulfil Indian regulatory requirements of ICMED including IMDR2017. This scheme is focused on assessment of those specific Indian regulatory requirements and enhance your compliance level. It is going to open priority doors for your business.

Why choose TÜV SÜD?

Benefit from our extensive pool of experts Beyond theoretical knowledge, we have decades of practical experience in fields non-active, active and in-vitro medical device auditing & certification. Our broad expertise enable a holistic perspective when assessing your company performance.

To ensure the right expertise for your project, we select the technical experts that match your needs. Our international network of technical experts provides additional support in the form of industry and specialist knowledge. With the backing of our large pool of medical device experts, we combine the expertise required for your project.


Your benefits at a glance

Improve your marketability and sales by applying the ICMED certification to your corporate documents. This can also significantly improve your bargaining position when taking part in public and private procurements.

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