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USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

  • 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

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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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AUSTRALIA: Effects on Australia Registrations by the EU MDR Transition – January/February 2023

AUSTRALIA: Effects on Australia Registrations by the EU MDR Transition – January/February 2023

  • 2023-01-19 06:20:26

Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.

Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.

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EU: Commission Implementing Regulation (EU) 2022/2346 and 2022/2347 of 1 December 2022 Laying Down Rules for the Application of Regulation (EU) 2017/745 – January/February 2023

EU: Commission Implementing Regulation (EU) 2022/2346 and 2022/2347 of 1 December 2022 Laying Down Rules for the Application of Regulation (EU) 2017/745 – January/February 2023

  • 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

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