Malaysia
The article describes updated guidance on re-registration and highlights the key aspects to be taken into consideration for the procedure. The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has published a second...
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
Asia
The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated thereto. Table of Contents The Health Sciences Authority (HSA),...
FDA
The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The article provides additional details regarding the medical device patient labeling. In particular, it describes the requirements regarding the appearance of text and graphics. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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