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January 17, 2020
Drugmakers Question OND’s Combination Product Reviews
Janssen flagged problems it faced during reviews of combination products in a comment to the Office of New Drugs.
January 17, 2020
FDA Schedules Workshop on Virtual and Augmented Reality in Medicine
The FDA will hold a March 5 public workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland.
January 17, 2020
MedTech Europe Renews Alarm Over MDR Transition
Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report.

January 17, 2020
Taiwan Passes New Medical Device Law
January 17, 2020
China Updates Requirements for Medical Device Clinical Trials
January 14, 2020
FDA Issues Guidance on PTA Balloon, Specialty Catheter 510(k) Submissions
January 14, 2020
New ISO Standard Helps Devicemakers Manage Risk
January 14, 2020
Canada Releases Final Guidance on Software as a Medical Device

January 14, 2020
FDA Exempts Powered Wheel Stretchers From 510(k) Requirements
January 10, 2020
FDA Issues Guidance on PTA Balloon and Specialty Catheter 510(k) Submissions
January 9, 2020
Taiwan Passes New Medical Device Management Law
January 9, 2020
EU Rolls Out New Guidance on Cybersecurity
January 7, 2020
FDA Renews Patient Engagement Advisory Committee

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