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Singapore: HSA has been recognized as a comparable overseas regulator for medical devices by the TGA

As released on the HSA NEX2US Issue 09 Newsletter (March 2023), Australia’s Therapeutic Goods Administration (TGA) recognized The Health Sciences Authority of Singapore (HSA) as a Comparable Overseas Regulator (COR) with comparable system for the evaluation of medical devices from September 2022.

This recognition enables HSA to join the ranks of the other 4 (four) respected TGA CORs, namely European Union, United States of America, Canada, and Japan. This recognition would also mean that the medical devices evaluated and approved by HSA are eligible for expedited registration pathways in Australia. Hence, resulting in shorter time to market for medical device companies, health institutions and patients in Australia.

For more information on the announcement, please refer to:

  1. TGA’s Guidance on Comparable Overseas Regulators for Medical Device Applications
  2. NEX2US Issue 09 (March 2023)

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