IVD analysers grouping requirements
You can group IVD analysers by families. Each analyser in a family should have:
- The same product owner
- The same proprietary name
- The same risk classification
- The same methodology/principles of operation
Differences among analysers within a family are allowed if they do not impact the diagnostic function. These permissible variants include:
- Differences in user interface
- Printing function
- Wireless capability
- Sample volume
- Onboard stability
- Calibration frequency
Grouping of IVD analysers within a family are not allowed if they contain:
- Differences that impact the diagnostic function or lead to different performance characteristics for their compatible reagent kits. For example, variants in:
- Measuring range
- Different methodologies or principles of operation
Accessories of the same or lower risk class may be included in the family.
You can also list your IVD analysers on the Singapore Medical Device Register (SMDR) with their respective IVD test kits under System grouping or list them separately as an IVD analyser FAMILY
Addition of new models
You can add new IVD analysers to an existing SMDR IVD analyser family listing if the new analysers fulfil the grouping criteria of IVD analyser FAMILY.
Please submit a Change Notification to make such additions.