October 20, 2023
By Sreenu Sattu
The Medical Device Control Division of the Thailand Food and Drug Administration (Thai FDA) has recognized the Singapore Health Sciences Authority (HSA) as a reference regulatory agency (announced in 2022). Therefore, the Thai FDA and Singapore HSA have agreed to collaborate to expedite the registration process of medical devices through a Regulatory Reliance Program.
As part of this program, the Thai FDA will assess the medical device's performance and safety, which was reviewed and approved by the Singapore HSA. The HSA will share its evaluation report with the Thai FDA.
The Thai FDA review time will shorten from 150 to 60 working days, on average, with a substantial reduction in the registration cost.
Who can participate and what is the process to participate in this Regulatory Reliance Program?
Product owners who wish to register medical devices or IVDs in Thailand with risk classification from Class B, C, and D already registered with the Singapore HSA, are eligible.
The Thai license holder/importer will sign a letter to request participation in the Regulatory Reliance Program and then submit the application for a medical device license through the electronic submission (e-submission) system.
What documents are required?
- A request letter to participate in this program by the importer and manufacturer
- A common submission dossier template (CSDT) identical to that submitted to the HSA, with the Letter of Authorization and declaration letters
- Change notification documents identical to that submitted to the HSA, if applicable
- Proof of medical device registration with HSA is usually obtained from the Singapore Medical Device Register (SMDR), a publicly accessible database.
The Regulatory Reliance Program expedites the review time and diminishes the review expense.
Emergo by UL as a Registrant (medical device registration license holder) to the manufacturer in Singapore signs on the consent form and includes the list of all MEDICS job reference numbers and provides it to the Thai local partner (license holder/importer) for them to submit to the Thai FDA (e-submission system). Emergo by UL will also provide a copy of the CSDT and change notification documents submitted to the HSA.
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