EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is intended to provide additional clarifications regarding the applicable regulatory requirements...
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
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