HSA released a self – help tool that will aid stakeholders in the grouping of medical devices. Grouping helps in determining the number of applications required to submit in order to gain a successful premarket approval. The cost and effort required for such process will be reduced and will definitely be helpful to HSA’s stakeholders.
Before beginning to use the grouping tool, a few things must be done:
- - The risk classification of the device must be determined. This can be accomplished by using another self – help tool, which can be accessed in the link below:
Medical device risk classification tool
- - If the applicant wants to register each device as a single product, the requirements must be checked first, which can be accessed in the link below:
- Medical device registration and licensing requirements
- - If there are doubts as to what grouping best suits the device/s in question, then the applicant can proceed to use the grouping tool.
The following are the key points in determining the medical device grouping using the HSA tool:
- - The type of device to be registered must be determined. The user can choose among Dental medical devices, Hearing aids, In vitro fertilization (IVF) media, In vitro diagnostic (IVD) medical devices, or other general medical devices.
- - The assessment tool will ask different questions to stakeholders depending on the chosen category.
- - Once the user has determined the grouping, a summary can be printed at the end of the assessment tool.
Introduction of Medical Device Grouping Tool