TMDA Guidelines on Good Review Practices: MD Regulation
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
The article outlines the basics of the regulatory framework for innovative medical devices.
The final article of the cycle clarifies certain specific regulatory matters associated with submissions, such as the applicability of transitional provisions or modifications to submissions and the way they should be introduced.
The new article further describes in detail the specific approach to be followed when making a submission, highlighting the key points to be considered by the parties involved.
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
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