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USA: US FDA's eSTAR Program – March/April, 2023

USA: US FDA's eSTAR Program – March/April, 2023

  • 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

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THAILAND: Thai FDA Introduced New E-Submission Procedure – September/October 2022

THAILAND: Thai FDA Introduced New E-Submission Procedure – September/October 2022

  • 2022-09-27 07:39:04

In order for Thai FDA’s quality control to conquer approval certificate issuance ratio, Thai FDA respectively announced a new E-Submission procedures governing Listing Medical Device, Notified Medical Device, and Licensed Medical Device applications (with exemption of class 1 auto approval), which has been effective since 1st August 2022.

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