The Indian Government has released guidance regarding when and how companies that are seeking clearance to import or manufacture medical devices can group products in a single submission. The document aims to support the introduction of the Medical Devices Rules, 2017.
The Indian government states that applicants can group medical devices with “similar intended uses or commonality of technology” into single submissions in certain circumstances. The products will fall into one of six categories that dictate their regulatory status, depending on the details of the collection of medical devices.
An example is that a developer of an in-vitro diagnostic (IVD) kit can seek regulatory approval for the reagents and articles used in the test through a single submission. Thus, once the kit is approved, the company can supply the reagents and articles as replacement items without needing regulatory clearance for each item individually. Although analysers and other instruments needed to perform the test cannot be covered by the single application. The guidance states that different rules may apply to other collections of medical devices.
Other categories that are defined in the guidance include IVD clusters, families and systems. The guidance notes distinctions that have implications for their regulatory status, however characteristics of the groupings overlap. Devices of the same risk classification can be grouped as a family but if the devices do not meet this criterion, they may be grouped as a system.
To view the guidance from the Indian government regarding grouping guidelines for medical device applications, please click here.