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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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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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THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

  • 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

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QT ANALYSIS: Quality Management System Requirements for Foreign Manufacturers – December 2022/January 2023

QT ANALYSIS: Quality Management System Requirements for Foreign Manufacturers – December 2022/January 2023

  • 2022-12-27 10:11:55

A Quality Management System (QMS) is used by a company or manufacturer as a set of policies, procedures, and processes. It provides a constructive handling and coordination of a business by continual improvements in effectiveness and efficiency. In this article, the QMS requirements for medical device manufacturer, company or organization on different countries will be explored.

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