Deciphering The Medical Devices Amendment Rules 2020
Infograph of the timelines for obtaining the registration for medical devices and IVD in India. The registration shall be on voluntary basis for a period of eighteen months (1st April 2020 to 30 Sep 2021), from the commencement of this rule, after which (from 01 October 2021), it shall be […]
Infograph of the timelines for obtaining the registration for medical devices and IVD in India. The registration shall be on voluntary basis for a period of eighteen months (1st April 2020 to 30 Sep 2021), from the commencement of this rule, after which (from 01 October 2021), it shall be compulsory.
Reference:
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.