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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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QT service highlight: Clinical Trial Service and Case Study

QT service highlight: Clinical Trial Service and Case Study

  • 2023-05-30 02:10:17

1. Qualtech is Part of Your Team

Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.

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QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

  • 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

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AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

  • 2023-05-24 07:26:30

TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.

If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.

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QT 活動: Qualtech將於 2023 年 4 月 28 日星期五舉行ASEAN法規更新網絡研討會

QT 活動: Qualtech將於 2023 年 4 月 28 日星期五舉行ASEAN法規更新網絡研討會

  • 2023-03-29 10:01:23

您是不是正在找尋一條進入各個亞洲市場的通路?
是不是想要簡單明瞭地取得各個東協國家之間的法規差異?
您是否有留意到東協醫療器材指令(ASEAN Medical Device Directive)將在進入多個東協國家之前予以簡化審查流程的機會?
想要了解更多、更廣、更全面的東協國家法規與市場資訊嗎?一同加入Qualtech的東協法規更新的線上研討會吧!研討會預計將於2023年4月28日下午4:00至5:30舉行,俗話說機會是留給有準備的人,所以,別錯過這次的精彩活動!

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