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  • Regulatory Update
2023年3月29日

UK Medical Device Regulators to Accept Extended EU Certificates

The UK MHRA will recognize extended CE Mark certifications recently announced in Europe
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  • Regulatory Update
2023年3月29日

Update from UK Life Sciences Council on Advisory Group Reform Proposals

UK advisory group to develop medical device regulatory reforms
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  • Regulatory Update
2023年3月27日

Guidance on European MDR Extension, MDR and IVDR Sell-off Period Deletion

European Commissioners have published a new Q&A resource document covering recent amendments to European Medical Devices...
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  • Regulatory Update
2023年3月27日

US FDA Transitions COVID-19 Guidance Documents for the End of Public Health Emergency

The US FDA issued a notice identifying how the agency plans to transition the guidance documents related to COVID-19...
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  • Regulatory Update
2023年3月20日

Amendment addressing extension of the MDR transitional periods and abandoning “sell-off” provisions goes into effect

The amendment addressing the extension of the MDR transitional periods and abandoning the “sell-off” provisions has...
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  • Regulatory Update
2023年3月14日

The European MDR Amendment: What to expect and When?

Key questions and answers on new amendment extending European MDR transition period
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  • Regulatory Update
2023年3月10日

US FDA Roundup: Revised EUA for Surgical Masks; Extended MDSAP Temporary Audit Measures and More

The US FDA has issued a number of updates, including revised emergency use authorizations (EUA) for surgical masks,...
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  • Regulatory Update
2023年3月10日

Vietnamese Regulators Amend Medical Device Registration Requirements

Vietnam Ministry of Health extends transition periods for higher-risk medical devices
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  • Regulatory Update
2023年3月9日

European Regulators Move to Increase Notified Body Capacity

Two Delegated Regulations from the European Commission will decrease frequency of Notified Body re-assessments under...
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  • Regulatory Update
2023年3月7日

Brazil Market Update: Amendments to RDC No. 751/2022 on Medical Device Registration and Notification

Brazil’s national health surveillance agency, ANVISA has published RDC No. 777/2023.
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  • Regulatory Update
2023年3月7日

Unanimous European Council Vote to Extend MDR Transition Periods

European Council vote means longer MDR transition timelines for qualifying medical devices
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  • Regulatory Update
2023年2月28日

ICPHSO 2023 Report: Michael Wiklund Discusses Key Human Factors Engineering Issues

Wiklund covers HFE, risk analysis and user risk mitigation at ICPHSO 2023 Annual Meeting
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