When registering a family of medical device in Thailand, manufacturers often seek to reduce regulatory complexity and costs by grouping similar products under a single license. However, the Thai Food and Drug Administration (TFDA) enforces specific criteria to determine whether devices can be classified as a “Family” and registered together.
What is a Family of Medical Device?
According to Thai FDA regulations aligned with the ASEAN Medical Device Directive (AMDD), a Medical Device Family is a group of devices that:
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Are manufactured by the same legal entity,
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Share the same intended use,
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Have a common design and working principle,
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Differ only by certain minor variations that do not affect the safety or essential performance of the devices.
Grouping devices into a family can streamline both registration and post-market activities, but only if the criteria are strictly met.
What Variants Are Accepted?
The Thai FDA has published detailed guidelines outlining which variations are acceptable within a medical device family. Permissible differences include:
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Size/Dimensions (e.g., length, diameter, gauge),
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Volume or Capacity,
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Color (when not affecting performance),
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Sterile vs. Non-Sterile versions,
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Packaging types, labels or blister formats,
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Flexibility or shape, when not functionally significant,
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Mounting types, connector styles,
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Coating or radiopacity,
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Concentration (in certain fluid-based devices),
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Software version (only if the core functionality remains unchanged).
These types of differences are considered cosmetic or secondary and are thus allowed in a single family registration.
You can find a detailed breakdown of Thai FDA classifications and grouping types (Family, System, Set, IVD Kit) in our complete guide to Thai medical device classification.
What Variants Are NOT Allowed?
Any change that impacts the device’s intended use, principle of operation, sterilization method, biocompatibility, or core performance will disqualify it from being grouped as part of the same family. Devices with significant differences must be registered as separate products or, in some cases, under a System registration if they work together as a functional unit.
To learn more about strategic registration planning, read our article on Thai FDA registration pathways.
Family of Medical Device variants: Conclusion
Understanding how to properly group a medical device is essential to avoid delays or rejections during Thai FDA registration. At Siam Trade Development, we help manufacturers navigate regulatory complexity with efficiency and clarity.
Need guidance? Contact us for a tailored assessment of your device portfolio.
