The Medical Device Control Division of the Thai Food and Drug Administration (Thai FDA) has issued guidance under its “Medical Device or Not?” series to clarify when contamination testing kits are considered medical devices in Thailand.
The guidance emphasizes that classification depends primarily on the product’s intended purpose.
No new regulatory requirements or registration procedures have been introduced.
Read the Thai FDA guidance here:
https://medical.fda.moph.go.th/press-release/medicaldeviceornot7
Purpose of the Guidance
To help manufacturers, importers, and other stakeholders determine whether contamination testing kits fall within the scope of Thailand’s medical device regulations based on their intended use.
When Contamination Testing Kits Are Considered Medical Devices
Contamination testing kits are considered medical devices when they are intended to:
- Measure and evaluate residual substances or contaminants on the surface of medical devices.
- Assess the effectiveness of sterilization products used for medical devices, where the product is specifically intended to be used with medical devices.
In these cases, the intended purpose directly relates to the safety, cleanliness, or sterilization of medical devices.
When Contamination Testing Kits Are Not Considered Medical Devices
Contamination testing kits are not considered medical devices when they are intended to:
- Detect ATP or protein residues on general surfaces for cleanliness monitoring or environmental hygiene purposes, such as nurse call buttons, counters, and other non-medical surfaces.
- Detect food allergen contamination in food ingredients or food products for food safety and manufacturing quality control purposes.
These intended uses fall outside the scope described for medical devices in the guidance.
Key Classification Consideration
The same or similar testing technology may be classified differently depending on its intended purpose, product claims, and stated use.
Stakeholders should therefore assess how the product is described and marketed when determining whether Thailand’s medical device requirements apply.
Implications to Clients
Manufacturers and importers of contamination testing kits should review:
- Intended use
- Product claims
- Labeling statements
to determine whether their products fall within the scope of Thailand’s medical device regulations.
Where a product is intended specifically for evaluating contamination on medical devices or assessing sterilization products used with medical devices, medical device regulatory requirements may apply.
No immediate regulatory action or new submission is required solely as a result of this guidance.
Effective Date
Informational guidance only.
No new regulatory requirements or specific effective date have been announced.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.