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”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/tr-02-r1-contents-of-a-product-registration-submission-for-in-vitro-diagnostic-medical-devices-using-the-asean-csdt(pub).pdf