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Medical device grouping tool

Check if you can group your medical devices for registration.

In accordance with GN-12-1 R3, IVD Cluster grouping has been removed and is no longer applicable. Please refer to GN-12-1 R3 for further information.

HSA | Guidance documents for medical devices

Before you begin:

  • You will need to determine your medical device's risk classification.
  • If you wish to register each medical device as a single product, please proceed to check your registration and licensing requirements before registration.
  • If you are unsure which grouping is most appropriate for your medical devices, please proceed with our assessment below.
1

What type of medical device are you registering?

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