Singapore HSA Publishes Updated Document on Technical Reference for Product Registration Submission for General Medical Devices

The Health Sciences Authority (HSA) Singapore has published an updated document on medical device technical reference, focusing on the contents of a product registration submission for general medical devices using the ASEAN CSDT, in August 2021. 

The main updates include additional information required for a device description, i.e., information on the medical device’s connectivity capabilities. For example, wireless enabled, Bluetooth enabled, internet-connected and network-connected devices. Other descriptive information such as security test reports and/or proof of the cybersecurity of the device and if the implemented cybersecurity control measures are effective will also be required. 

Software verification and validation studies is also important for a software product. Another update discussed in the latest document is that the Product Owner of a device will be required to provide the actual software version that will be supplied in Singapore during the product registration process.  

Submission of the software version number that represents the various software changes/iteration is required and is important for the purpose of identification and traceability after the product or device reaches the market. This will assist in field safety corrective actions as well. 

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

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