The Union health ministry is likely to refrain from requirement of conducting clinical trials in India for European Union (EU) approved medical devices, reports said.
The decision is aimed at removing regulatory obstructions and to ensure increased access to latest generation medical devices in the Indian market.
This will be applicable on the condition that the concerned medical device is marketed for at least two years in EU countries. The objective can be implemented through an amendment of Rule 63(1) under the Medical Devices (MD) Rules, 2017.
According to a recent Drug Technical Advisory Board (DTAB) recommendation, the government will soon notify permission to import or manufacture medical device which does not have its predicate device.
A predicate device is a medical device that may be legally marketed in the US and used as a point of comparison for new medical devices seeking approval through US FDA’s 510(k) premarket clearance pathway.
A premarket notification is a submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (predicate device) that is not subject to premarket approval.
As per fourth provision of Sub rule 1 of Rule 63, the results of clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom (UK) or the United States (US) or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.
The rule also specifies that the applicant provide an undertaking in writing to conduct post marketing clinical investigation with the objective of safety and performance of such investigational medical device as per protocol approved by the Central Licensing Authority.