Indian government issues guidance on Grouping Medical Devices in a Single Submission

[bio_subbu]

The Indian government issued two new guidelines on “Grouping Medical Devices in a Single Submission” and “FAQ on Grouping Guidelines issued under Medical Device Rules 2017” that allows applicants importing or manufacturing medical devices in India to group medical devices with “similar intended uses or commonality of technology” into one submission. This implies that if an application is accepted for a medical device kit, replacing these items within this kit will not require any subsequent application. However, higher risk devices within a kit will not be covered by the single application.
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[supadrai]

Re: Indian government issues guidance on Grouping Medical Devices in a Single Submiss

This is a pretty interesting idea India has come up with. Unfortunately, it seems to depart from any type of harmonization. I wonder whether a kidney dialysis kit (including things like medical gloves and tubing) would fit nicely into a system or a group.