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QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATE FOR 2024  - DECEMBER/JANUARY 2024

QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATE FOR 2024 - DECEMBER/JANUARY 2024

  • 2023-12-28 09:01:53

In this latest edition, we navigate the evolving landscape of medical device regulations, marked by progress and heightened vigilance. The improvement of technology and healthcare is making things better for patients, but it also needs careful supervision. Over the past year, global regulatory bodies have demonstrated adaptability, reinforcing frameworks to manage medical device registrations effectively.

This edition offers a concise analysis of the latest mandates, impending updates, and pivotal shifts for 2024, addressing the exchange between technological innovation and the mission to ensure global safety and efficacy.

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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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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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QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATES – January/February 2023

QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATES – January/February 2023

  • 2023-01-19 06:48:57

The development of medical devices is significantly influenced by the rapid pace of technology. While these cutting-edge devices may improve healthcare services, they also pose major risks to public health and safety. Due to this, regulatory agencies throughout the world have been continuously developing and updating their regulations to strengthen their management of product registration and mandate that applicants submit more detailed documentation. This article will cover the recently issued, upcoming, and influential worldwide medical device regulation updates for the year 2023 in various countries.

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SINGAPORE: HSA Publishes Regulatory Guidelines for Laboratory Developed Tests (LDTs) – January/February 2023

SINGAPORE: HSA Publishes Regulatory Guidelines for Laboratory Developed Tests (LDTs) – January/February 2023

  • 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

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