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...
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...
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...