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...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the classification of general medical devices. The document describes in detail the applicable classification rules...
Uncategorized
The Health Sciences Authority (HSA), Singapore’s medical device regulating authority, has published the new revision of the guidance on medical device field safety corrective actions. General Overview of the Field Safety Corrective Action The recent guidance...
Asia
Learn about what Global Medical Device Regulations regulatory stands for: If you are strong exporter of medical devices, you should know about global medical device regulations. Canada The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the...
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