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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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 QT Activity: Qualtech's Internal Southeast Asian Regulatory Training and End of the Year Party 2022 – January/February 2023

QT Activity: Qualtech's Internal Southeast Asian Regulatory Training and End of the Year Party 2022 – January/February 2023

  • 2023-01-19 06:29:59

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

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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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SINGAPORE: Regulatory Fee Revision for Health Products – January, 2022

SINGAPORE: Regulatory Fee Revision for Health Products – January, 2022

  • 2022-01-26 10:55:53

The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses.

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QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

  • 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

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SINGAPORE:  HSA Announced Draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) – August, 2021

SINGAPORE: HSA Announced Draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) – August, 2021

  • 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

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