Clarification For Import Of Non-Notified Medical Devices
Non-Notified Medical Devices donot require Registration certificate and Import Licence for import into India
File No. 29/Misc/3/2012-DC (169)
8th Jan 2013
Medical devices which are notified under the provisions of Drugs and Cosmetics Act 1940 requires Registration certificate in Form 41 and Import Licence in Form 10 for import into India. However, the devices which does not attracts the provisions of Drugs and Cosmetics Act 1940 & Rules there under may be released by concern port officer of CDSCO without insisting NOC from this office.
Recent Posts
Regulatory Challenges of SaMD: Navigating Global Standards and Compliance
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
The Future of SaMD: Emerging Trends and Innovations
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring...
Understanding SaMD: What Makes Software a Medical Device?
Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device...
Contact us
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.