ABSTRACT
Enterprise Singapore reported that the number of home-grown medtech companies has increased from 100 in 2014 to more than 250 2019, and over half of these were start-ups. The Health Sciences Authority (HSA) was formed in 2001. The regulatory controls are in place to safeguard public health and safety and assuring access to good quality, safe and effective products. A rule-based system is used in the determination of medical device risk classification. It is dependent on the intended purpose and indications for use claimed by the product owner. The inherent risk depends on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture, and use. In Singapore, applications to HSA must be submitted online via Medical Device Information and Communication System (MEDICS). The company that submits the application to HSA must be a local entity company based in Singapore.
