Singapore Medical Device Registration – HSA Approval
A series of proposed changes to the Health Product (Medical Device) Regulations 2010 have been announced by the Health Sciences Authority (HSA), Singapore. The proposed amendments intend to further improve the regulatory framework to facilitate access and innovation while safeguarding consumer health and safety. Singapore’s Health Sciences Authority (HSA) announced changes to its regulations that it says will facilitate faster access to certain medical device registration and mobile applications and provide more clarity to device makers.
Specifically, the agency says it plans to exempt some devices from registration requirements based on risks and other factors, such as whether the device is approved by other international regulators and how long it 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).
Beginning on 1 June 2018, HSA says that device makers 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.
HSA will also be allowing certain Class B (low-moderate risk) 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 says 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 recognizes the US Food and Drug Administration, EU notified bodies, Australia’s Therapeutic Goods Administration, Health Canada and Japan’s Ministry of Health, Labor and Welfare as reference agencies.
Mobile medical applications that fall under Class B and Class C will also qualify for immediate registration, so long as they are approved by at least one reference agency and have no known safety issues.
With those criteria, HSA says that three-quarters of Class B devices will qualify for the immediate access route.
HSA also announced several changes 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 smartwatch) 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.
HSA is also clarifying that high-risk cosmetic and appearance-altering devices such as implants and injectable fillers are subject to regulatory controls and the agency says it has developed a list of specific devices to help industry identify whether their device is regulated.
Lastly, HSA says that the makers of complex devices will be required to provide training to physicians and other end users to ensure the devices’ safe use.