Family grouping requirements
Medical devices under a Family have to meet all of the following requirements:
- From the same product owner
- Have the same risk classification
- Have a common intended purpose
- Have a common design and manufacturing process
- Have variants that are within the scope of permissible variants
Devices grouped together using a Family grouping, but are of different proprietary or brand names, will be listed separately on the Singapore Medical Device Register (SMDR).
Addition of new models
For addition of new medical devices, the following apply:
|New medical devices
Have the same brand names as already registered medical devices
Can be added to SMDR through a Change Notification
Belong to same family, but have different brand names from registered medical devices
Submit a new product registration
The following can be grouped as a Family:
- Condoms that differ in colour, size and texture but are manufactured from the same material, using common manufacturing process and share a common intended purpose.
- IV administrative sets that differ in features such as safety wings and length of tubing, but are manufactured from the same material, common manufacturing process and share a common intended purpose.
- Steerable guidewires that are available in various lengths and have various tip shapes and tip flexibilities, if their variations fall within an allowable scope.
- Cardiac catheters that are available in a different number of lumens, lengths and diameters.
- Contact lenses with additional features of UV protection, as this feature does not affect the basic design and manufacturing of the lens.
The following cannot be grouped as a Family:
- Contact lenses are available as toric lens or spherical lens. These products have different intended purposes and performances. They are designed and manufactured differently.