Singapore’s Health Sciences Authority (HSA) has announced changes to its regulations that aim to facilitate faster access to certain medical devices and provide greater clarity to medical device manufacturers. The agency plans to exempt some devices from registration requirements based on risks and other factors, for example, whether the device is approved by other international regulators and how long the device has been on the market.
As with other regulators, Singapore classifies medical devices using a four-tier risk classification system, from Class A (low risk) to Class D (high risk). From 1st June 2018, HSA states that device manufacturers will no longer have to register Class A sterile devices. Instead the devices will only need to be listed on the agency’s online Class A database and comply with post-market surveillance requirements.
Also, HSA will be allowing certain Class B (low-moderate risk) medical devices to use the agency’s immediate registration route, by which a device is registered immediately upon submission, rather than waiting 60 days under the agency’s expedited registration pathway. To qualify for immediate registration, HSA states that Class B devices must either have “no safety issues associated with the device globally” and be approved by two other reference regulators, or be approved by one reference regulator and have been on the market for at least three years in that country. HSA currently recognises the United States Food and Drug Administration, European Union notified bodies, Australia’s Therapeutic Goods Administration, Health Canada and Japan’s Ministry of Health, Labour and Welfare as reference agencies.
HSA has also announced changes that are meant to clarify the regulatory status of certain types of devices. Specifically, HSA is clarifying that software-based devices intended solely for well-being or lifestyle purposes, such as a heart rate monitor in a smart watch, are not subject to regulatory controls but must include a statement in their labelling and advertising that the device is not meant for medical use. The HSA has also stated that manufacturers of complex medical devices will be required to provide training to physicians and other end users to ensure the devices’ safe use.
To read more about the HSA legislation for faster access to medical devices and improved clarity on regulatory controls, please click here.