The government set up certain guidelines in pursuance of the Rule 5 of Medical Device Rules, 2017. These guidelines are concerned with grouping different medical devices into one application for easing up the medical equipment registration process.
The guidelines are concerned with an application for a license to import or manufacture for sale or distribution, sale, stocking, or offer for sale or distribution of medical devices under Medical DevicesRules, 2017.
According to these guidelines, an applicant can group medical devices with same or similar uses or common technology in a single application. This application can be concerned with the license to import or manufacture medical devices in India.
These guidelines club medical devices into six groups, which are:
- In-vitro diagnostic test kit
- In-vitro diagnostic cluster
Let’s learn about these groups in detail:
A medical device can be grouped as single if it is sold as a distinct packaged entity and does not meet any criteria of the other five groups. For example, devices sold in packages of 2, 6, 10 or other numbers of units can be classified as single. Similarly, in a first aid kit all individual medical devices are classified as single.
This refers to a collection of medical devices where each device is from the same license holder and falls in the same risk classification. Moreover, they must have common intended use, same design, same manufacturing process, and have variations within the permissible scope. For example, syringes in a package can be of different sizes but they are basically the same.
The in-Vitro diagnostic test kit
This refers to devices that comprise reagents and articles that are from the same license holder, intended to be used in combination and sold under a single proprietary name. It should also not include the instruments required for testing.
Medical devices grouped as a system must be intended to be used in combination to complete a common intended purpose and only be compatible when used as a system. Plus all individual devices must have been manufactured by the same license holder and sold under the same proprietary name
In-Vitro diagnostic cluster
This combines a number of in-vitro diagnostic reagents or articles which share a common methodology and are compatible when used as a test kit. Plus all devices should be manufactured by the same license holder under the same name.
A collection of two or more medical devices supplied in a single package by the same license holder. For example, a first-aid kit with different medical devices from different manufacturers.
Classifying medical devices into groups will simplify the medical device registration in India. While helping manufacturers procure licenses easily for their business activities.