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TFDA Expands Expedited Reliance Route to Include Class B, C, and D Singapore Registrations
Published on: June 9th, 2022
Updated on: June 27, 2022
Reliance Route Allows Leveraging of Singapore Licenses
On June 20, 2022, the TFDA released an updated announcement outlining the expansion of the Singapore Reliance Route program. This program, initially piloted with only Class D/Class 4 products, is now open to all Class B, C, and D medical devices. To qualify, the product must be approved and actively listed on the Singapore Medical Device Registry and have used the Common Submission Dossier (CSDT) for its application. Reliance Route applications will need to be submitted with identical CSDT documentation that was used in Singapore and will require the coordination of the Singapore Registrant.
Qualifying products will be exempted from the Expert Review and will reduce the review time to a maximum of 60 days while also saving manufacturers US$1,700 (53,000 Baht). This is especially significant for Class 2, 3, and 4 devices as the TFDA review times for standard applications can be up to a year.
The Thai FDA originally initiated the Regulatory Reliance Program in late 2021. More information can be found in our blog here.
How to Utilize the Reliance Route
Manufacturers will need to work with a local Thai authorized representative, like Asia Actual, to submit a standard registration application e-submission to the Medical Device Control Division of the Thai FDA with the following documentation:
- The registration documents in the form of Common Submission Dossier Template (CSDT) that is identical to the CSDT documents used to register with the HSA agency.
- The change notification documents that are authorized by the HSA agency (if any),
- The letter to request a participation in the Regulatory Reliance Program,
- The evidence of medical device registration of HSA agency, Singapore.
Once the e-submission application number has been received, the Singapore Registrant will need to complete the Thailand FDA & Singapore HSA Reliance Model Consent Form (Consent Form) allowing the HSA to send their evaluation documents to the TFDA. With offices in Singapore and Thailand, Asia Actual can make utilizing the Regulatory Reliance program very easy.
QR Codes for the participation letter and the Singapore Registrant Consent Form can be found in the announcement.
Fees and Timelines for Registering a Medical Device in Thailand
Exact review timelines in Thailand are still being observed given the recent implementation of new regulations. However, the TFDA has provided the maximum review time.
|Classification||App & Approval (All)||Expert Review (Standard App)||Max Review Time (Standard App)||Reliance Route Review Time|
|Class 1||2,500 Baht (US$ 85)||N/A||200 days||60 days|
|Class 2||11,000 Baht
|53,000 Baht (US$ 1,800)||250 days||60 days|
|Class 3||11,000 Baht
|53,000 Baht (US$ 1,800)||250 days||60 days|
|Class 4||21,000 Baht
|53,000 Baht (US$ 1,800)||300 days||60 days|
Specialist Reviews in Thailand
Not all 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 90-120 days to an application’s review time along with an additional $1,700 fee. Currently, 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 a quick, inexpensive pathway to grow their sales in the region.
Expert Reviews come with a 53,000 baht fee and can add up 120 days of review time.
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.