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European Union flag flying in the wind
  • Regulatory Update
2023年10月20日

New European Guidance Clarifies Medical Device Software Requirements

The EC and MDCG address medical device software compatible with or embedded in hardware devices (such as smartphones,...
Singapore skyline at night
  • Regulatory Update
2023年10月20日

Thailand FDA and Singapore HSA Regulatory Reliance Program

The Thai FDA has recognized the Singapore Health Sciences Authority as a reference regulatory agency to expedite...
Drawing of box with FDA logo on it
  • Regulatory Update
2023年10月17日

RAPS Convergence 2023: eSTAR updates from the US FDA

The same week that eSTAR became compulsory for all 510(k)s submitted to the US Food & Drug Administration (FDA), several...
Doctors discussing an X-Ray
  • Regulatory Update
2023年10月11日

RAPS Convergence 2023: Clinical Evidence on European Medical Devices

Continuing coverage of the RAPS Convergence 2023 conference, we examine the issue of European Medical Devices Regulation...
Two test tubes sitting on a desk
  • Regulatory Update
2023年10月10日

RAPS Convergence 2023: IVDR and Clinical Evidence Requirements

Emergo by UL report from the RAPS Convergence 2023 conference on IVDR compliance considerations and challenges.
Montreal Canada 2023
  • Regulatory Update
2023年10月9日

RAPS Convergence 2023: The Status of European Notified Bodies

Emergo by UL reports from the latest Regulatory Affairs Professionals Society (RAPS) medical device regulatory and...
EU flag waving in front of a building
  • Regulatory Update
2023年10月5日

European Updates: MDR Transition, Manual on Borderline and Classification

European regulators have clarified MDR Annex XVI transition periods, as well as updated their latest Manual on...
FDA news picture 0923
  • Regulatory Update
2023年9月27日

US FDA Announces Permanent Accreditation Scheme for Conformity Assessment Program

The US FDA issued several regulatory updates, including ASCA becoming a permanent program, guidance for participation in...
People reviewing plans on a wall
  • Regulatory Update
2023年9月18日

Details on Declaration Route for Class I Medical Devices in Israel

As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced (August...
FDA news picture 0923
  • Regulatory Update
2023年9月13日

US FDA Finalizes 2016 HFE Draft Guidance for Combination Products

FDA released new Q&A-style guidance document finalizing 2016 HFE draft guidance for combination products
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  • Regulatory Update
2023年9月5日

UK MHRA Announces Three New Approved Bodies to Certify Medical Devices

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated...
Bern Switzerland
  • Regulatory Update
2023年9月1日

Medical Device and IVD Compliance in Switzerland: Key Deadlines and Reminders

Key medical device and IVD registration and compliance considerations now that Switzerland has "third country" status in...
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