Japan PMDA Updates MDSAP Policies Ahead of 2022 Implementation Deadlines
Japanese regulators prepare for full acceptance of MDSAP audit reports for medical device quality management system (QMS) conformity assessments in 2022.
EU Regulatory Roundup: Combination Products, Eudamed, COVID-19 IVDs
Latest guidelines from European Medicines Agency (EMA) and EC Medical Device Coordination Group (MDCG) on CIV-ID generation for clinical studies, COVID-19 IVD performance evaluations and more.
US FDA Medical Device User Fees See Modest Increase for 2022
FDA has set a 2.5% increase for medical device user fees for its 2022 fiscal year. Learn more about US medical device and IVD regulations at Emergo by UL.
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.