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SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

  • 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

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社會公益: 資助中國貧困的小朋友

社會公益: 資助中國貧困的小朋友

  • 2022-09-27 07:33:24

2000年Qualtech在臺北成立,其後在世界各地成立了多個據點,多年来Qualtech 除了始終堅持提供醫療器材的法規諮詢、產品註冊、臨床設計與執行、當地授權代理人、上市後追蹤等高品質與專業的服務之外,也不忘記屬於Qualtech的企業責任,正因為我們從事著與醫療相關的產業,我們更加著重於幫助與關愛弱勢團體。

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QT ANALYSIS: The Impact of Unique Device Identification (UDI) System on Medical Device Registration – June/July 2023

QT ANALYSIS: The Impact of Unique Device Identification (UDI) System on Medical Device Registration – June/July 2023

  • 2023-06-28 09:59:48

Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.

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AUSTRALIA: EU MDR transition extension – June/July 2023

AUSTRALIA: EU MDR transition extension – June/July 2023

  • 2023-06-28 09:52:24

The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.

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SINGAPORE: Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices– June/July 2023

SINGAPORE: Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices– June/July 2023

  • 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

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