New Guidelines from Japanese Regulators Cover Medical Device Cybersecurity, Remanufactured Devices and MDSAP Reports
Latest guidelines from Japan MHLW and PMDA address medical device cybersecurity, remanufactured devices and MDSAP applications. Learn more at Emergo by UL.
Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions
FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.
How Legacy Medical Devices and IVDs Will be Managed in Europe’s Eudamed Database
Unique device identifier assignments and guidelines for legacy devices whose CE Marking will remain valid after MDR, IVDR come fully into force
US FDA Recommendations for Voluntary Recalls of Medical Devices and Products
Final guidance from US FDA covers how manufacturers and distributors should develop and initiate voluntary recalls of products including medical devices, IVDs and pharmaceuticals. Learn more at Emergo by UL.
Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices
Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.
European Regulators Publish New Q&A on Custom-Made Medical Devices
Manufacturers of custom-made medical devices (CMD) have a new FAQ resource for MDR compliance from the European commission's medical device coordinating group, or MDCG. Learn more at Emergo by UL.
Singapore HSA Explains New Developments for COVID-19 Test Kit Authorizations
The Singapore health sciences authority (HSA) announced that it is no longer accepting provisional authorization (PA) applications for COVID-19 test kits.
US FDA Revokes Emergency Use Authorizations (EUA) for Some Personal Protective Equipment (PPE)
US regulators have revoked emergency use authorizations for some non-NIOSH-approved personal protective equipment (PPE) as the country's COVID-19 public health emergency situation evolves. Learn more at Emergo by UL.
New Notified Body Designated to IVD Directive in Europe
A second Polish Notified Body, CeCert, has been designated under the European In-Vitro Diagnostic Medical Devices Directive (IVDD).
European Commission Offers New Guidance on Medical Device Standards Development
European Commission group provides new guidance on current and future approaches to medical device standards harmonization and development.