US FDA Publishes EUA Templates for COVID-19 IVD Submissions
The new and updated templates support Emergency Use Authorization (EUA) for IVDs intended for the diagnosis and/or treatment of COVID-19.
US FDA Ramping up Permanent 510(k) Exemptions for Dozens of Medical Devices
Nearly 100 low- and moderate-risk medical devices may soon be exempt from 510(k) premarket notification requirements in the US, according to a new FDA notice.
Cold Chain Management for COVID-19 Vaccines: Ensuring Safe and Effective Distribution
What pharmaceutical, medical device and other manufacturers should consider as vaccine cold chain processes evolve.
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In Brief: Vietnamese Ministry of Health Proposes New Decree for Medical Device Regulation
The Vietnamese Ministry of Health published a draft decree meant to consolidate and expand the country's regulatory framework for medical devices.
IVDR Watch: IVD Expert Panel Now Accepting Submissions for Performance Evaluation Consultations
The European Commission's Expert Panel for IVDs is now accepting submissions from Notified Bodies for consultations on performance evaluations for high-risk IVD devices.
NMPA Publishes Revised Chinese Medical Device Regulations
Emergo by UL experts have conducted an initial review and identified the new information about the regulations that medical device manufacturers and importers will need to know.
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.