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Device Grouping

What is device grouping?​

The SFDA permits manufacturers to include up to 50 devices in a single MDMA application, reducing regulatory burden and costs for product families or device ranges.

Conditions for grouping​

Devices can only be grouped in one MDMA application if they meet all of the following conditions:

  • Same legal manufacturer
  • Same risk class
  • Same intended use (generally)
  • Similar design principle and mode of action

Devices with significantly different intended uses, different classes, or different manufacturers cannot be grouped together.

Benefits of grouping​

  • Single application fee covers the group (fees may still vary by group size)
  • Single MDMA certificate issued for all grouped items
  • Streamlined SFDA review for similar devices
  • Simpler renewal management

Practical considerations​

  • All devices in the group must meet all technical file requirements
  • The SFDA may request individual device-specific data where the devices differ in clinically meaningful ways
  • Grouping large numbers of devices can increase the complexity of the technical file and potentially extend review time

IVD grouping​

IVD devices may also be grouped under the same conditions. For IVDs with multiple reagent configurations or lot sizes, grouping is common practice.

Further reading​