Singapore HSA Publishes Updates on Technical Reference for Submission of In Vitro Diagnostic Medical Devices

The Health Sciences Authority (HSA) Singapore published a latest update on medical device technical reference, discussing about the contents of a product registration submission for In Vitro Diagnostic (IVD) medical devices using the ASEAN CSDT, in August 2021. 

The important updates include some additional information required for a device description, which is information on the medical device’s connectivity capabilities. Wireless enabled, Bluetooth enabled, internet-connected and network-connected devices are some of the examples. Further requirements also include descriptive information such as security test reports and/or proof of the cybersecurity of the device and if the implemented cybersecurity control measures are efficient. 

When it comes to a software product, software verification and validation studies is crucial, and this is also discussed in the updated guidance document. Another update discussed is the requirement for the Product Owner of a device to provide the actual software version that will be supplied in Singapore during the process of product registration.  

More details can be found in “Medical Device Technical Reference: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT, August 2021”:  

Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News