As part of its effort to create a more formalized system of registration requirements, India is imposing new rules for medical devices sold in that country.
Published in January 2017, India’s Medical Device Rules 2017 include the use of a risk-based classification scheme for all medical devices and in-vitro devices (IVDs), as well as the implementation of unique device identification (UDI) requirements. Additionally, manufacturers of medical devices will be subject to manufacturing quality audits conducted by Notified Bodies that have been specifically authorized to carry out such audits. The new rules also include fee changes based on the updated system.
On the plus side, licenses issued under the new rules will be valid for a three-year period, compared with just one year under current regulations. Companies that have devices that are already registered for sale in India will be granted a transition period in which to bring their products into compliance with the new requirements. And, the requirements regarding the use of UDIs for medical devices and IVDs will not take effect until January 1, 2022, a full four years after the initial implementation date.