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...
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),...
Asia
The present article provides an overview of the regulatory requirements to be applied for the premises used for the distribution of medical devices. In particular, the article addresses the aspects related to the storage conditions required to ensure medical devices...
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...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control. The document covers the regulatory matters related to design verification and...
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