China Update: IVD Classification Rules, Medical Device Self-testing Requirements
Chinese regulators issue new IVD classification rules based on CFDA and IMDRF efforts, plus requirements for self-testing and self-inspection for medical device registrants
European Commission Announces Appointments to Medical Device, IVD Expert Panels
European Commissioners have announced expert panelists for 12 high-risk medical device and IVD categories ahead of MDR, IVDR dates of application. Learn more at Emergo by UL.
UK MHRA Provides Registration Requirements for IVDs Undergoing Performance Evaluation
The United Kingdom's medicines and healthcare products regulatory agency, (MHRA) updated its medical device and IVD registration guidance to include a section on IVDs undergoing performance evaluation.
Consultation Open for Swiss Ordinance Governing IVD Products
The Swiss federal office of public health (FOPH) announced the opening of a public consultation on the draft in vitro diagnostics ordinance (IvDO) and amendments to the ordinance on clinical trials for medical devices (ClinO-MD).
EC MDCG Explains Eudamed Requirements for Actors Under MDR, IVDR
New MDCG Q&A explains Eudamed registration requirements and obligations for actors that do not fall under MDR Article 31 or IVDR Article 28. Learn more at Emergo by UL.
Five Tips to Make the Most of Your Human Factors Validation Protocol Pre-Sub to the US FDA
How medical device and drug companies can take full advantage of presubmission consultations with the US Food and Drug Administration regarding HF validation test protocol reviews.
Canadian Regulators Issue New Reporting Requirements for Medical Device Shortages
Canadian regulators explain reporting content, timeframes and related elements of new regulations coming in March 2022 to better manage medical device supply shortages.
US FDA Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices
US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.
Brazilian Regulators to Allow Sales of COVID-19 Self-Test Kits to Consumers
Brazil's ANVISA offers expedited registration for coronavirus self-test kits for consumer use. Learn more at Emergo by UL.
IVDR Watch: Updated Joint Implementation Plan Targets Risk of IVD Shortages
An updated IVDR joint implementation plan addresses risks to European IVD supplies due to compliance and capacity issues. Learn more about EU IVD regulations at Emergo by UL.