ANVISA
The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
HPRA
The new article describes in detail the requirements in-house IVDs are subject to.
Malaysia
The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use in Malaysia.
DRAP
The new article highlights the critical points related to the application process, outlining the key steps to be taken when applying for approval in a clinical investigation.
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
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