Requirements For The Regulatory Control Of Medical Devices In India

In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, Medical Devices notified by Central Government are regulated under the said Act. List of notified medical devices is available on CDSCO website i.e. www.cdsco.nic.in

The document is intended to provide non-binding guidance for use in the registration of medical devices in India.

The document elaborates requirements covering :

Requirements For Common Submission Format For Registration Of Medical Devices In India

Rules Related To Registration Of Medical Devices In India

Licence for Manufacture of Medical Devices in India Proposed Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices In India under CLAA Scheme is intended to provide non-binding guidance for use in the regulation of medical devices.

Requirements for Grant of Licence in form-28 for Manufacture of Medical Devices in India

Requirements for Conducting Clinical Trial (s) of Medical Devices in India

In India import, manufacturing, sale and distribution Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, Medical Devices notified by Central Government are regulated under the said Act. List of notified medical devices is available on CDSCO website i.e. www.cdsco.nic.in

The proposed “Requirements for Conducting Clinical Trial (s) of Medical Devices in India” are being uploaded for the information of all stakeholders likely to be affected thereby for comments, if any.

The document is intended to provide non-binding guidance for conducting clinical trial (s) of medical devices in India.

The above mentioned proposed requirements are being uploaded for the information of all stakeholders likely to be affected thereby for comments, if any.

Any person interested making any suggestions on the above mentioned 3 documents may do so in writing for consideration of the CDSCO with in a period of 20 days from the date of their uploading through post to the Drugs Control General (India), CDSCO, FDA Bhavan, Kotla Road, New Delhi – 110002 and through email at cdamdi@gmail.com

Courtsey : Forum Co-ordinator Association Of Indian Medical Device Industry, (AIMED) GL-3, Ashoka Estate, 24, Barakhamba Road, New Delhi - 110 001