The Health Sciences Authority (HSA) Singapore updated its regulatory legislation to facilitate faster access for certain lower-risk medical devices and standalone mobile applications. The changes will take effect from 1 June 2018.
The Health Science Authority (HSA) Singapore has recently announced that its regulatory legislation will be enhanced to facilitate faster access for certain lower-risk medical devices and standalone mobile applications. The changes will take effect from 1 June 2018.
The regulations for the following devices will be enhanced as follows:
- Class A sterile medical devices, such as sterile examination gloves and sterile intravenous sets, will not need to be registered with the HSA
- The current expedited Class B registration route (60 days), will be put under the immediate registration route if there are no safety issues associated with the device globally and the registration is supported by approvals from two independent regulatory agencies or approval from one reference agency and three years of marketing history
- Class B and C standalone mobile medical applications (e.g. standalone applications for the calculation of insulin dosages, or live monitoring of ECG for cardiac patients) that are approved by at least one regulatory agency and have no safety issues globally will be eligible for immediate market access under the immediate registration route
Moving forward, the time-to-market for new medical devices will be shortened enabling consumers to access these lower-risk products earlier.
Read another article on these new amendments HERE.