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Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

  • 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

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Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

  • 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

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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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USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

  • 2022-06-29 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

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