medical devices Archives - rwr-regs

China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation
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China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation

2022, China, February 2022, Medical Devices, Members-Only, Moderate Update

China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation

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China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulationstuart.mccully2022-08-07T16:44:24+00:00

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’
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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

2021, December 2021, Medical Devices, Members-Only, Minor Update, USA

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’stuart.mccully2022-08-07T16:56:09+00:00

USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, USA

USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devicesstuart.mccully2022-08-07T17:16:19+00:00

UK – MHRA: Software and AI as a Medical Device Change Programme
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UK – MHRA: Software and AI as a Medical Device Change Programme

2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, UK

UK – MHRA: Software and AI as a Medical Device Change Programme

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UK – MHRA: Software and AI as a Medical Device Change Programmestuart.mccully2022-08-07T17:17:15+00:00

UK – MHRA Launches Public Consultation on Future of Medical Device Regulation
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UK – MHRA Launches Public Consultation on Future of Medical Device Regulation

2021, MDR, Medical Devices, Members-Only, Moderate Update, September 2021, UK

UK – MHRA Launches Public Consultation on Future of Medical Device Regulation

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UK – MHRA Launches Public Consultation on Future of Medical Device Regulationstuart.mccully2022-08-07T17:19:47+00:00

EU | Guidance on Implant Cards for Medical Devices
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EU | Guidance on Implant Cards for Medical Devices

2021, EU, June 2021, MDR, Medical Devices, Members-Only, Minor Update

EU | Guidance on Implant Cards for Medical Devices

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EU | Guidance on Implant Cards for Medical Devicesstuart.mccully2022-08-07T17:29:18+00:00

EU | European Medical Device Nomenclature (EMDN)
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EU | European Medical Device Nomenclature (EMDN)

2021, EU, June 2021, MDR, Medical Devices, Members-Only, Moderate Update

EU | European Medical Device Nomenclature (EMDN)

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EU | European Medical Device Nomenclature (EMDN)stuart.mccully2022-08-07T17:31:56+00:00

Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devices
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Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devices

2021, Denmark, July 2021, MDR, Medical Devices, Members-Only, Significant Update

Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devices

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Denmark – Guidance on Applying for a Permit for Clinical Trials of Medical Devicesstuart.mccully2022-08-07T17:46:35+00:00

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