Litigation and Consulting

Medical devices rules, 2017

Medical Device Rules 2019 was introduced on. 31st January 2017. The devices that have been declared under the rules are now considered drugs under Section 3(b)(ii) of the Ducks and Cosmetics Act 1940. The standards that have to be complied with by the manufacturer will be those that may be prescribed under the MD Rules, 2019.

If the medical device does not comply with the standard, the prosecution shall be maintainable under Section 32, which shall be punishable under Section 27 of the Drugs and Cosmetics Act 1940, Provisions for “clinical research organisation” means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding the conduct of a clinical investigation or clinical performance evaluation has been provided. The manufacturer has to ensure that a medical device is safe and conforms to the essential principles of safety and performance for medical devices.