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 compulsory.
Reference:
Recent Posts
AI/ML-Based Medical Devices — Emerging Regulatory Questions
Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms b..
Post-Market Surveillance for Cosmetics in India: What CDSCO Expects After Launch
Getting a Cosmetic product registered and onto shelves in India is only half the job. Once a product is in the market, the Cosmetics Rules, 2020 place ongoing duties on manufacturers and Importers to ..
Software as a Medical Device (SaMD) - India’s Regulatory Stance
Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD..
Need Help?
Submit your EnquiryOffice Locations
- Delhi
- Bangalore
- USA
- Singapore