Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong
US: +1 512 898-9222
SG: +65 8800-3197
Sources and Links
Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status
Published on: October 25th, 2021
Updated on: June 9th, 2022
Fast Track Option Reduces Review Time and Saves Money
The Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand. By avoiding the Specialist Review, the Program intends to reduce the review time to 60 days while also saving manufacturers the $1,700 (53,000 Baht) Review fee. The program is meant to leverage device conformity assessments performed by the Singapore HSA for expedited registration in Thailand.
The process involves the local Thai authorized representative submitting a standard registration application for pre-submission to the Medical Device Control Division of the Thai FDA with the addition of (1) a letter of request to participate in the Regulatory Reliance Program, and (2) evidence of registration in Singapore. Note that the CSDT documents must match exactly with those submitted (updated with any change notification) in Singapore.
UPDATE: Per a TFDA announcement on June 1, 2022, all products registered by the HSA are now eligible for the Reliance Route. More information can be found in our blog here.
Coordinating with the Manufacturer’s Singapore Registrant
Subsequently, the Registrant (license holder) for the device in Singapore will then submit a Consent Form to the Singapore Health Sciences Authority (HSA), thus providing the authority for a HSA application evaluation report to be shared with the Thai FDA.
This process is fairly straightforward, but it will require full cooperation and close coordination between the Registrant in Singapore and the applying license holder in Thailand.
After experience with the Thailand FDA – HSA Singapore Regulatory Reliance program is well established with high-risk class devices, it is likely to then be extended to lower risk category devices
Specialist Reviews in Thailand
Not all Class 4 devices will be selected by the TFDA for a Specialist Review but those that do are often novel devices, those with short market history, and/or lacking sufficient documentation, in their opinion. Being selected for Specialist Reviews can add up to 120 days to an application’s review time along with an additional US$1,700 (THB53,000) fee. For example, the TFDA has been selecting every device utilizing Artificial Intelligence (AI) for a Specialist Review due their unfamiliarity with the technology and its novelty. When combined with the Malaysia Medical Device Authority’s preference for Singapore approved devices, this new program offers manufacturers of high risk, high-tech devices another quick, inexpensive pathway to grow their sales in the region.
Below are the fees associated with Class 4 applications in Thailand:
|Risk Classification||Registration Type||Submission Fee||Specialist Review Fee (Novel Devices)||Approval Fee||Total Fee (with Specialist Review)||Max Review Time|
|Class 4||Licensing||1,000 Baht
|150 to 300 days with a Specialist Review|
Come Grow with Us
Asia Actual has an office in Singapore and 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 specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.