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Thai FDA Issues Guidance on Specialist Review Selection Criteria
Published on: February 16th, 2023
Specialist Review Guidance for Medical Device Registration Available Now from Thai FDA
Under the new medical device Rules (ref. Medical Device Act/Ordinance B.E. 2562 (2019)), the Thai FDA may require a Specialist Review for certain products as part of the premarket approval review process. However, in the past, it has been hard to predict what devices would be subject to this kind of review. Now the TFDA has published new, welcome guidance for Specialist Review via their Medical Device Control Division website, which can be found here.
This new guidance provides manufacturers with specifics on what could trigger a Specialist Review which can add 3 to 6 months to a standard TFDA medical device registration timeline, and up to 53,000 BAHT depending on the class of device.
More information on the Thai Specialist Review and registration process is located on our website here. If you have any questions about the Specialist Review process in Thailand, or other specific functions of the Thai FDA, feel free to contact us here.
Products That Require Specialist Review from the Thai FDA
Specialist Review is an extra process added to a standard registration application review where the Thai FDA sends a technical file for review by an outside agent, typically a medical doctor or researcher. The following medical devices are required to undergo an expert review as a necessary element of the medical device registration process:
- Novel technology (e.g. AI); new technology previously unused in Thailand.
- At home medical devices previously intended for hospital use. These include devices such as laser hair removal, LED red light treatment for wrinkle reduction and laser acne treatment.
- Non-hyaluronic acid products for skin defect repairment, face-lift products such as polydioxanone thread lift, golden thread lift and other products that are used for autologous procedures such as PRP (platelet rich plasma) and stem cell.
- Medical devices that have a history of serious adverse events (or deficiencies that could cause serious adverse events).
- Medical devices identified by specific Health Ministry announcements. These devices include OVDs, Fillers, HIV test kits, and Blood bags. These products require full CSDT submission.
If a medical device falls under these categories, it will be subject to review by an expert, which will take a more extended period of time to register. However, there are situations where these kinds of devices can be exempted from the Specialist Review process.
Exemption from Thai Specialist Review based on Reference Country Approval
There are some exceptions to the rules outlined above depending on the countries where a medical device has already been approved. Specifically, if a medical device has received approval from the governing bodies listed below, and are in accordance with the following rules, they are exempt from the Specialist Review process. The details are as follows:
- The device must have been approved for at least 3 years by one of the below governing bodies, or more than 1 year if the device has been approved by multiple of said governing bodies. The approved medical device in those countries must have the same intended use, indication, labelling, instruction for use, and packaging as the product that is intended to be registered in Thailand.
- Medical devices must have approval from the following governing bodies:
- Therapeutic Goods Administration (TGA), Australia
- Health Canada (HC)
- European Union Notified Bodies (EU NB)
- Japan Ministry of Health Labour and Welfare (MHLW)
- US Food and Drug Administration (US FDA)
- WHO Prequalification of in Vitro Diagnostics (IVD)
Exception from Thai FDA Specialist Review based on Other Criteria
If the medical device has not been registered in any of the above countries, there are still other ways manufacturers can avoid an expert review. In order to ensure this, manufacturers must meet one of the following requirements:
- The medical device has been approved in Singapore and registered under the Singapore Reliance program.
- The medical device has been approved by the Thai FDA drug department.
- The medical device has been ‘transferred’ with no changes of intended use, indication, components, primary packaging, manufacturing process and address.
- The medical device has been manufactured in Thailand and continuously sold to a governmental department, a government hospital or a university for 3 years, without any serious reported adverse events in its history.
The requirement for a Specialist Review as part of the medical device registration process in Thailand can add significant cost and time to the standard registration process. It is important to evaluate the new criteria to determine how registration of products in your portfolio will be affected.
Come Grow With Us
Asia Actual has an office in Bangkok staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through device registration, independent license holding, direct fulfillment, and a variety of sales channel support services.