Manufacturers of medical devices will be required to take specific actions to eliminate or mitigate potential risks associated with the use of their products already on the market in Singapore, under new regulations published by the country’s Health Sciences Authority (HSA).
The new Field Safety Corrective Action guidance strengthens regulations which were first set forth ten years ago in Singapore. It mandates that manufacturers take all actions reasonably necessary to reduce the risk of death or serious deterioration in the state of health associated with the use of medical devices. It requires the HSA to be informed of all such corrective actions taken by a manufacturer, and that not only the manufacturer, but its authorized representatives, importers and suppliers, be subject to the regulations. The new regulations apply to corrective and preventative actions, post-market surveillance and recalls initiated by the manufacturer.