Australia Accepts US FDA 510(k) for Class III & IIa Devices
On 16 October, an amendment to Australian legislation was published that expands the conditions for medical devices already marketed in…
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FDA Issues Draft Guidance on Chemical Analysis for Devices
The FDA issued draft guidance on September 19, 2024, concerning its recommendations related to chemical analysis for biocompatibility assessment of…
FDA Recognizes New Sterility Standards for Medical Devices
Currently the FDA recognizes 100’s of consensus standards from reputable organizations such as ISO, ANSI, AAMI, IEC, ASTM, etc. These…
FDA Final Rule Changes for Medical Devices and LDTs
The final rule related to medical devices and LDTs (Laboratory Developed Tests) was finalized in April 2024 by the FDA.
MHRA Introduces PMS Update to UK Medical Device Regulations
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the first significant update to…
ARTG User Guide Updates for Custom & PMMD Devices
User guides have been updated to include the transition eligibility content. While custom made devices are now exempt from requirement…
Update to MDCG 2021-25: Key Clarifications on MDR Transition
The MDCG 2021-25 (Rev1.0) has been updated, reflecting the latest developments in the MDCG MDR Transition. The guidance now takes…
Understanding the Role of Notified Bodies in MDR Compliance
Similar to the role of Economic Operators, it is important to recognize that Regulation (EU) 2017/745 (MDR) includes a…
The IGJ Highlights the Importance of an Effective PMS System
The inspections conducted by the Healthcare and Youth Care Inspectorate (IGJ), based in the Netherlands, focused on evaluating manufacturers’ adherence to Post-Market…
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