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Australia’s Therapeutics Goods Administration published a regulatory amendment and corresponding guidance on the DoC requirement for low-risk IVDs.

Determining proper human tissue models for medical device usability testing

The new guidance document expands on MDCG 2020-17’s advice for conducting virtual audits of medical device manufacturers during the COVID-19 pandemic.

Following Brexit, medical device and IVD clinical study sponsors will face different sets of requirements in the EU and UK

Entering users’ homes offers unique opportunities for researchers, along with certain risks to be avoided. The best practices outlined here can help.

New FAQ covers Actor Registration Module issues in Eudamed

The Canadian regulator seeks to ensure stability by continuing its current emergency measures and by crafting longer-term amendments to prolong their desired impact.

COFEPRIS intends to boost efficiencies of expedited market access routes for qualifying medical devices

The new documents released by the European Commission offer insights into the new system that will require Notified Body intervention for many previously self-certified IVDs, along with a fresh attempt to call for harmonized standards under MDR and IVDR.

The Agency published eligibility criteria and application guidelines for the certification, which is used for FDA-approved medical devices manufactured outside the US and shipped to a different non-US country.

What does a robust CAPA process for medical device quality assurance and safety look like?

The Medical Device Authority Register (MDAR) has been rolled out to replace the Malaysia Medical Device Register (MMDR), although some of the search functionality is not yet complete.

The Taiwan Food and Drug Administration provided information for public consultation on labeling and database rules for Class II and III medical devices and IVDs, along with phased implementation timelines.

The agency has published this document to clarify the two distinct review processes available to medical device manufacturers who have been denied a Certificate to Foreign Government (CFG) for a given product.

Post-Brexit challenges for placing medical devices on the market in Northern Ireland