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.
More This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonised judgement of the significance of a change.
More TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.
If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.
In order to standardize the management of radiofrequency aesthetic devices, the CMDE issued the “Guidance for the Registration and Review of Radiofrequency Aesthetic Devices”.
More The MDA published the Second Edition Guidance Document, “Classification Of Rehabilitation, Physiotherapy And Speech Therapy Device” (MDA/GD/0061), on March 08, 2023. This document is directed to give manufacturers and authorized representatives (AR) an appropriate guideline on the classification of rehabilitation, physiotherapy, and speech therapy products. This guidance document classifies a number of products used for rehabilitation, physiotherapy, and speech therapy as medical devices or non-medical devices respectively, based on the manufacturer's stated intended purpose.
More This guidance document describes the requirements and notification process for the applicant to get approval from the Authority prior to the importation and/or market placement of custom-made medical devices.
More On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.
More This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.
More The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.
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Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.
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