In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.