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Grouping Rules

TH-Unique · ASEAN CSDT grouping · Multiple devices in one application

What Is Grouping?​

Thai FDA allows multiple devices to be covered under a single CSDT submission where they meet defined grouping criteria. Grouping reduces the number of applications needed and can significantly reduce registration costs and timelines for product families.

The Six Grouping Types — TH-Unique​

Thailand's CSDT framework recognises six distinct grouping types:

1. Single Device​

A single specific model/configuration. The baseline — not a grouping type per se, but the reference point for all other types.

2. Family​

Definition: Multiple device models that share:

  • The same manufacturer
  • The same intended purpose
  • The same design concept and principle of operation
  • The same materials in patient-contacting parts
  • Differences only in size, shape, colour, or minor configuration

Examples:

  • A range of catheters in multiple French sizes (6Fr, 8Fr, 10Fr, 12Fr)
  • Orthopaedic implants in multiple sizes (same design, varying dimensions)
  • Surgical scissors in different lengths

Eligibility check: If you change the material, intended purpose, or operating principle between models, they cannot form a Family — they require separate applications.

3. System​

Definition: Multiple devices that are:

  • Designed and intended to be used together as an integrated functional unit
  • Each component performs a distinct function that contributes to the overall system purpose
  • May include both Class 1 and higher-class devices (system is classified at the highest class of its components)

Examples:

  • Infusion system: pump + infusion set + pressure monitoring
  • Patient monitoring system: monitor + ECG leads + SpO2 probe + NIBP cuff
  • Surgical robot: robotic unit + control station + surgical instruments

4. Set​

Definition: Multiple devices that are:

  • Packaged together for a specific clinical procedure
  • Intended to be used together (or separately) for that procedure
  • Not necessarily integrated — may be individual devices in a procedure pack

Examples:

  • Wound care procedure pack (dressings, forceps, gloves, gauze)
  • Central line insertion kit
  • Biopsy procedure set

5. IVD Test Kit​

Definition: An IVD product comprising:

  • A primary test reagent or kit
  • Ancillary reagents, standards, controls, calibrators
  • All components intended by the manufacturer to be used together

Examples:

  • ELISA kit (plate, conjugate, substrate, stop solution, controls)
  • PCR diagnostic kit (reagents, positive control, negative control, primers)

6. IVD Cluster — TH-Unique​

Definition: Multiple IVD test kits or products from the same manufacturer that:

  • Detect/measure the same analyte or pathogen
  • Use the same basic technological platform
  • Are intended for different specimen types or user settings

Examples:

  • Serum-based ELISA + whole blood rapid test — both testing for the same hepatitis B antigen
  • Professional-use PCR kit + point-of-care rapid test — same target analyte, different platforms for different settings

Grouping Eligibility Requirements — Common to All Types​

Regardless of grouping type, all devices in a group must:

RequirementDetail
Same manufacturerAll devices have the same legal manufacturer
Same intended purposeAll serve the same primary clinical function
Same device nameCommon trade name for the group (with model distinguishers)
Same classificationOr if mixed, submit at the highest class

How to Apply Grouping​

  1. Select the appropriate grouping type
  2. List all models/variants to be included with their full model identifiers
  3. Provide a table comparing specifications across all variants (showing shared features and allowed differences)
  4. Prepare a single CSDT covering all models in the group
  5. Include separate labelling/IFU for each variant where labelling differs
Grouping reduces but doesn't eliminate documentation

Even in a grouped application, each device variant must be adequately described and its characteristics documented. The CSDT must cover the full range of variants, not just one representative model.

Changing a Grouped Application​

If a new variant is added to an existing approved group, submit a variation notification to Thai FDA. The new variant must meet the same grouping eligibility criteria as the original group.