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NIST Releases Updated Cybersecurity Framework

The National Institute of Standards and Technology (NIST) is an agency of the US Department of Commerce whose mission is to promote innovation in America. The agency has updated the widely used Cybersecurity Framework (CSF), its landmark guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types, from the smallest…
Tehelj
March 6, 2024
February 14, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device

This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…
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February 14, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. swissdamed – Swiss Database on Medical Devices The “going-live” date being deferred to the 2nd half of 2024
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January 3, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. Devices manufactured and used in healthcare institutions General information and notes on in-house devices according to MedDO and IvDO New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices…
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November 17, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

TGA webinar on Australian UDI implementation

The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…
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November 10, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
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