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Health Sciences Authority

Grouping medical devices as a Family

Medical devices with the same product owner and common intended purpose, and design and manufacturing processes. Variations need to be within the scope of permissible variants.

Last updated 13 March 2026

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

Permissible variants

Specific products

Permissible variants for specific products

Specific products

Permissible variants

Abutments

Retention (e.g. cement or screw)

Active implantable devices

MR conditional and non-MR conditional

Antibiotic test (IVD)

Concentration

Biopsy forceps

Formable or non-formable

Blood bags

  • Anticoagulants (same composition and different concentration)

  • Additives (different composition and concentration)

Catheter

  • Number of lumens

  • Material: PVC (polyvinylchloride), PU (polyurethane), nylon, silicone

  • Curvature

  • Coating material for lubrication

Condoms

  • Flavour

  • Texture

Contact lens

  • Diopter

  • UV protection

  • Tinting

  • Colour

  • Wearing schedule (i.e. daily wear, extended wear)

  • Replacement schedule (i.e. daily, weekly, monthly)

Defibrillators

  • Automatic or semi-automatic

Dental brackets

Material

Dental handpieces

  • Material

  • Rotational speed

Dermal fillers

Same composition but different concentration/density

Diagnostic radiographic systems

  • Number of slices

  • Digital vs analog

  • Biplane and single plane

  • Flat panel vs cassette

  • PET ring size

Electrophysiological catheter

  • Electrode spacing

  • Number of electrodes

Gloves


  • Powdered or powder-free

Gamma camera

Number of detectors

Guide wire


With or without inert coating material

Orthopaedic/dental implants


  • Cemented or non-cemented fixation

  • Collar

Intra-ocular lens

  • Monofocal or multifocal

  • Single piece or multi-piece

  • Aspheric or spheric

Implantable pulse generators

Number of chambers (cardio)

IV cannula

  • Presence of injection port

  • Presence of safety wing

IVD rapid tests

Different assembly format: cassette, midstream, strip

IVD urinalysis strips

Different combination of testing configurations

Polymer products

With or without plasticisers (e.g. DEHP)

Stent

  • Delivery system, (i.e. over the wire or through the scope)

  • Flaps, flares or sleeves

Suture

  • Number of strands

  • Pledgets

  • Loops

  • Dyes

Suture passer

Design of jaw, handle or needle

Tracheal tube (endotracheal or tracheostomy tube)

With or without cuff

Wound dressings

Different formats (e.g. solutions, creams, gels loaded onto pads)

X-ray detector

Scintillator material

General products

General permissible variants

  • Coating material (for lubrication only)

  • Colour

  • Concentration with same indication and mechanism (same concentration, different amount of constituents)

  • Diameter, length, width, gauge

  • Dimensional design differences for child and adult use (differences due to different patient population are allowed e.g. volume and length)

  • Flexibility

  • Holding force

  • Isotope activity level

  • Memory storage

  • Method of sterilisation (to achieve same sterility outcome)

  • Printing capability

  • Radiopacity

  • Shape, size and volume

  • Sterility status (sterile vs non-sterile)

  • Type of device mounting (e.g. ceiling mount, wall mount or standing)

  • Viscosity (the change in viscosity is solely due to changes in the concentration of constituents)

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 and registration

New medical devices

Registration

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

Examples

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.