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USA: Final Premarket Notification (510(k)) Submissions Guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheter – June/July 2023

USA: Final Premarket Notification (510(k)) Submissions Guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheter – June/July 2023

  • 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

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MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

MALAYSIA: MDA Update 4th Edition of MDA/GD/0020: Change Notification for Registered Medical Device – December 2022/January 2023

  • 2022-12-27 05:48:52

The Malaysia Medical Device Authority (MDA) released the latest 4th Edition Change Notification for Registered Medical Device, MDA/GD/0020. More substantial changes were made compared to the 3rd Edition. There are new additional clauses and updated documents requirements. The MDA revised the turn-around time for Category 2 and Category 3. Furthermore, some changes do not require a change notifications to be submitted to MDA.

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THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

  • 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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THAILAND: Thai FDA Notification on Licenses Renewal Guideline – November,2021

THAILAND: Thai FDA Notification on Licenses Renewal Guideline – November,2021

  • 2021-11-24 09:26:58

As we approach the end of the year, Thai FDA published a renewal guideline for licensed and notified medical device manufacturing and importation licenses that will be expired on 31 December 2021. To continue to engage in their respective activities, manufacturers and importers shall comply with this guideline within 1st October to 31st December 2021.

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