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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 :
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.
The document elaborates requirements covering :
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 document elaborates details covering :
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 |
