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The Union health ministry is likely to waive requirement of conducting clinical trials in India for European Union (EU) approved medical devices through an amendment of Rule 63(1) under the Medical Devices (MD) Rules, 2017.
This is aimed at removing regulatory bottlenecks and to ensure increased access to latest generation medical devices in the Indian market.
Besides this, waiver is also applicable on the condition that the concerned medical device is marketed for at least two years in EU countries.
“In this regard, the government will soon notify permission to import or manufacture medical device which does not have its predicate device,” according to a Drug Technical Advisory Board (DTAB) recommendation made recently.
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 [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA).
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 further stipulates that there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behavior and performance in Indian population.
It also stipulates that the applicant has given 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.
EU representatives had also pointed out during the meeting of India-EU Sub-commission on trade held on June 6, 2018 in New Delhi that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by regulatory authorities of US, UK, Australia, Canada or Japan.
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