Last July, the Health Sciences Authority (HSA) of Singapore transitioned its online portal for product registration and approval submissions from the previous MEDICS system to SHARE. On 21 October, 2025, HSA revised two guidelines (GN-17, GN-18) on product registration preparation using ASEAN CSDT for medical devices and in vitro diagnostic medical devices.
The key revisions to the product registration preparation guidelines for medical devices and in vitro diagnostic medical devices are as follows:
1) Product registration applications for medical devices and in vitro diagnostic medical devices must be submitted through the SHARE platform.
- Technical dossiers and supporting documents must be submitted in soft copy via SHARE and uploaded to the corresponding folder under the Supporting Documents section of the SHARE application.
2) A Machine Learning (ML) section has been added to the CSDT elements in accordance with GL-04 Regulatory Guidelines for Software Medical Devices including Machine Learning-Enabled Medical Devices-A Life Cycle.
- In this section, information regarding ML functionality, performance validation, risk analysis, and other related details can be uploaded.
3) ISO 13485 certification bodies must be either accredited by IAF-recognized accreditation bodies or be EU MDR/IVDR Notified Bodies.
Please refer to the attached documents below.
If you have any questions about medical devices,
please contact us with the below.
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