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NIST Releases Updated Cybersecurity Framework

By Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

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…

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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Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device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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November 3, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 30 Oct)

Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…
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October 27, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

TGA medical devices vigilance program pilot

The TGA is commencing a 12-month pilot of the new Medical Devices Vigilance Program. Sponsors who have medical devices included in the Australian Register of Therapeutic Goods can volunteer for the pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities. More information on this program…
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October 13, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Weekly update from GOV.UK for: Department for Science, Innovation and Technology

  New £60 million Regional Innovation Fund among measures to boost research and development Page summary: A £60 million Regional Innovation Fund (RIF) that will boost support for universities in areas with lower levels of R&D investment is among new measures Technology Secretary Michelle Donelan has announced.  
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September 22, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Dutch IGJ: Appeal to manufacturers: take action to meet IVDR requirements

The Dutch Health and Youth Care Inspectorate (IGJ) plans to conduct inspections to assess whether Netherlands-based manufacturers comply with IVDR requirements on vigilance and post-market surveillance. This announcement was made following a survey they conducted involving Netherlands-based manufacturers of IVDs to understand the status of the transition to Regulation (EU) 2017/746 IVDR. A summary of the results have been published on…
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September 15, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.
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September 1, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Brazilian regulator ANVISA amends medical device import law

On 18 August, Brazil’s medical device regulator ANVISA issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Notification and Registration of Medical Devices. This amendment allows medical devices and accessories to be imported into Brazil if manufacture date precedes registration date. Brazil’s Import Manual was also updated to reflect this amendment. More information on this amendment can be found here.…
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August 11, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

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.
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August 4, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

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…
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