Brazil ANVISA Legislation Allows Leveraging Regulatory Authorizations for Medical Devices
Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil.
Stand-alone Medical Software Compliance
This white paper provides an overview of IEC 62304, IEC 60601 and IEC 82304 standards for software.
MHRA Opens Public Consultation on Common Specifications for High-Risk IVDs
UK MHRA releases details of a four-week public consultation on high-risk IVDs
UK MHRA Announces Draft Recognition Policy Access Routes
This is the second post in our series on the UK MHRA initial draft recognition policy. Following our initial post, this regulatory update describes the access routes in the UK MHRA’s draft policy to leverage international regulatory authorizations.
UK MHRA Announces Draft Recognition Policy for Access to Global Medical Device Markets
This is the first in our series on the UK MHRA initial draft recognition policy to leverage international regulatory authorizations for access to the medical device market.
The European Artificial Intelligence Act: Key Elements and Best Practices
Medical device makers will want to read the second story in our series covering the implications of the EU Artificial Intelligence Act.
Medical Device Software and Cybersecurity
Maintaining safer medical devices: how medical device regulations, standards and guidance are keeping pace with the proliferation of medical device software.
EU Update: Medical Device Regulator MDCG Releases New Guidance on Safety Reporting for IVD Clinical Performance Studies
In April, the MDCG released new guidance regulating IVDs in Europe. It examines safety reporting requirements for IVD performance studies under the IVDR.
Medical Device Registration Pathway and Regulatory Requirements in the Chinese Market
In this webinar, our experts will discuss the medical device registration pathway and regulatory requirements in the Chinese market.
Mexico COFEPRIS Announces Revised Labeling Standard
This is our fourth update on the recently released draft standard published by Mexico’s medical device regulator COFEPRIS for medical device labeling, NOM-137-SSA1-2024.