Device Grouping / Clusters

Last Updated on February 22, 2022

For the purpose of product registration, multiple medical devices may be grouped according to the methods of grouping. The basic methods of grouping consist of the following, namely:

i) one generic proprietary name
ii) one manufacturer
iii) one common intended purpose

Medical devices may be grouped into one of the following categories, namely:
i) single
ii) family
iii) system
iv) set
v) in-vitro test kit or
vi) in-vitrocluster

Detailed description on the abovementioned methods is provided in Schedule B of the Medical Devices Rules, 2017