Thailand Medical Device Grouping Rules: Simplifying Registration and Saving Costs

Thailand Medical Device Grouping Policy

The Thai FDA has implemented new grouping guidance for medical devices to simplify the application process, offering manufacturers a more cost-effective and time-saving route for market access. Grouping allows multiple similar products to be included under a single registration submission.

📜 Three General Grouping Rules

To qualify for any grouping category, products must adhere to three fundamental criteria:

1. One generic proprietary name: The devices must share a common recognized name.
2. One product owner: They must be owned and controlled by the same legal entity.
3. One common intended purpose: They must be used for the same general clinical objective.

📦 Grouping Categories and Definitions

The Thai FDA recognizes several specific grouping categories:

• Single Device: Complies with the three general rules and only varies in package size or number of units.
• System: Follows the general rules and contains a medical device working in combination with accessories to achieve a common intended purpose.
• Family: Complies with the general rules and has a common risk classification, design, and manufacturing process, but allows for minor permissible variants (e.g., color, size, sterilization method).
• Set: Consists of two types of medical devices that follow the general rules and are imported and sold in the same packaging. Classification is based on the highest-risk device in the set.
• IVD Test Kit: Complies with the general rules, is labeled as a kit, and does not include an analyzer.
• IVD Cluster: Complies with the general rules, is manufactured by a common entity, is either Type 1 or Type 2 risk, and has a common methodology (e.g., containing two different test kits and reagents).

➕ Permissible Variants for a 'Family' Grouping

The 'Family' grouping is the most flexible and allows for differences in characteristics that do not impact the core safety or efficacy of the device. Examples of permitted variants include:

• Physical Dimensions: Diameter, Length, Width, Gauge, Shape, Size, and Volume.
• Aesthetics/Non-Functional: Color, Flavor (for devices like condoms), and Texture.
• Operational Differences: Sterility status (sterile vs. non-sterile), Radiopacity, Printing capability, and Method of sterilization (to achieve the same sterility outcome).
• Product-Specific Variants: For catheters, this includes the number of lumens or the material (PVC, PU, Nylon, Silicone).