Thailand: Fast Tracks Registration of Class D Medical Devices with Singapore Approval Status

ARQon
Dec 17, 2021
2 min read

July 08, 2021

The Thai FDA has introduced a Regulatory Reliance Program in Thailand where Class D (Class 4 in Thailand) medical devices and IVDs listed in Singapore Medical Device Registry can be exempted from specialist review requirement. This program will shorten the registration duration from 150 working days to 60 working days. The registration costs will also be reduced by 53,000 baht, a waiver cost on the expert review process.

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 (US$105) 53,000 Baht (US$ 1,767) 20,000 Baht (US$ 667) 74,000 Baht (US$ 2,539) 150 to 300 days with a Specialist Review

Process 1. Establishment signs a letter to request a participation in the Regulatory Reliance Program. 2. The manufacturer or importer uses the electronic submission (e-submission) system to submit an application for a medical device license with the following documents:

CSDT
Change notification document authorized by HSA (if any)
Letter to request a participation in the Regulatory Reliance Program
Evidence of medical device registration of HSA agency, Singapore

3. The registrant in Singapore (the company that owns the medical device license from the HSA agency) signs the Thailand FDA & Singapore HSA Reliance Model Consent Form (Consent Form) to authorize the HSA agency to deliver the medical device evaluation report to the Medical Device Control Division, Food and Drug Administration of Thailand after receiving an application number in the e-submission system. 4. An officer of Thailand FDA sends the request back to the manufacturer or importer to attach the Consent Form in the e-submission system.

Sources:

Thailand FDA - HSA Singapore Regulatory Reliance