Other Updates Regulatory Affairs Newsletter Archive – Page 9

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TGA publishes new guidance on manufacturer evidence for IVD medical devices

Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.

adminAugust 11, 2023

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Swissmedic weekly update (WC 24 July)

Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…

adminAugust 4, 2023

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CLSI publishes EP33, 2nd Edition, Use of Delta Checks in the Medical Laboratory

CLSI has published guidelines on the use of delta checks in the medical laboratory. It details different approaches for validation of measurements for which delta checks are useful. It outlines the procedures to determine delta check limits and regulations for comparing current clinical results with previously reported outcomes for a specific patient. It also covers the steps involved in initiating…

adminJuly 14, 2023

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TGA phases out ISO 13485 certificates for IVD devices

The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for IVD devices has ended on 26 May 2023. TGA no longer accepts these certificates to support IVD applications. More information on this can be found here.

adminJune 8, 2023

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CEN adopts ISO 17043 as European standard

CEN have formally adopted ISO 17043: Conformity assessment — General requirements for proficiency testing as a European standard. This may impact EQA providers providing proficiency testing services such as end user POCT schemes for staff proficiency.

adminMay 26, 2023

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US EPA update (17 May)

Please note this is an extract of the original bulletin. Proposal removes low volume and exposure exemptions for new PFAS and other persistent chemicals, ensuring robust safety review WASHINGTON (May 16, 2023) — Today, the U.S. Environmental Protection Agency (EPA) proposed amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA)…

adminMay 19, 2023