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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2024

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USA

Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

Guidance on Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway



EUROPE

Q&A In Case of Interruption or Discontinuation of Supply Of Certain Medical Devices and in Vitro Diagnostic Medical Devices

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

Guidance on qualification of in vitro diagnostic medical devices

Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams



AUSTRALIA

TGA responds to questions on essential principles, clarifying effect on industry

Amendment: Guidance on the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices)



BRAZIL

ANVISA informs that change in the petition for clinical research of medical devices



FINLAND

Medical device operator: check the information entered in the register for the control fee to be confirmed in 2025



INDIA

Medical Device Adverse Event Reporting Form



IRELAND

Frequently Asked Questions on Notification for In-house Manufacturers of Medical Devices and in vitro Diagnostic Medical Devices



SAUDI ARABIA

Guidance on Innovative Medical Devices

SFDA Guidance on Content of Labeling of Contact Lenses and its Solutions



THAILAND

FDA reduces approval and licensing procedures, maintaining the safety of medical devices as a top priority



UNITED KINGDOM

Update: Guidance on Clinical investigations

As part of the process to obtain UKCA, CE, or CE UKNI marking for your medical device, a clinical investigation may be required. And required to notify the MHRA at least 60 days prior to commencing the investigation.

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