This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.
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 HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.
More The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices
More The Circular 10/2023/TT-BYT was issued on May 11, 2023, amending some templates of the Circular 19/2021/TT-BYT, which was combined with the Decree 98/2021/ND-CP.
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1. Qualtech is Part of Your Team
Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.
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.
More To mitigate the risk of nanomaterials, the amendment has been made by the Therapeutic Goods Administration (TGA) to the existing Essential Principle 7 to include the additional obligations. The amended Essential Principles checklist can be viewed and downloaded from TGA’s website.
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”.
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