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.
The Thai FDA and Singapore HSA have agreed to collaborate to expedite the registration process of medical devices through a Regulatory Reliance Program.
Participation is possible if you are a medical device registered in Singapore, and As a risk classification 4 or D of an In Vitro Diagnostic medical device (IVD) or Non-In Vitro Diagnostic medical device (Non-IVD).
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.
Please refer to the file below for the detailed process and required documents.
If you have any questions about medical device in Thailand and Singapore,
Please contact us with the below.
info@jnmglobal.net
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