Jun 5, 2018
EMERGO SUMMARY OF KEY POINTS:
Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018.
The Singaporean Health Sciences Authority’s (HSA) Health Products (Medical Devices) Regulations have been devised to allow faster market access for lower-risk devices and mobile medical applications, as well as to clarify regulatory requirements for some digital and high-risk devices.
Key components of the HSA reforms are examined below.
One aim of the HSA’s regulatory changes is faster Singaporean market access for lower-risk devices. To that end, Class A sterile devices will no longer be required to register with the HSA prior to commercialization in the country. (Manufacturers of Class A sterile devices will still have to list their products in the regulator’s Class A database, however.)
Furthermore, Class B devices that currently qualify for the HSA's expedited registration route will move to the immediate registration route if they meet criteria including:
HSA anticipates that three quarters of all Class B applications will qualify for immediate registration based on these criteria.
In addition, Class B and C standalone mobile medical apps that have already been approved by at least one reference market regulator (Health Canada, Japan PMDA, US Food and Drug Administration, Australian TGA or European Notified Body) and no reported safety issues will also qualify for immediate Singaporean registration.
HSA has also included clarifications to existing regulations for digital health and higher-risk devices in this latest update:
Under the medical device regulatory changes, HSA also plans to boost post-market surveillance efforts both domestically and by closer monitoring of alerts and safety issues in foreign markets.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS
EMERGO SUMMARY OF KEY POINTS: