HSA, SMF unveil MedTech ecosystem to enhance regulatory readiness

SME Centre@SMF will offer services such as regulatory consultations, horizon scanning workshops, and whitepapers.

The Health Sciences Authority (HSA) and the Singapore Manufacturing Federation (SMF) have launched a new integrated support ecosystem for the MedTech sector, aimed at strengthening regulatory readiness and accelerating market access.

The initiative combines SME Centre@SMF’s advisory services with the technical expertise of HSA’s HPRG Innovation Office, offering early-stage regulatory consultations to help firms shift from reactive compliance to proactive planning.

As part of broader market facilitation efforts, HSA has introduced a regulatory reliance pilot with Malaysia’s Medical Device Authority (MDA), running from 1 September to 28 February, to enable faster registration of Class B, C, and D medical devices.

To further support industry capability, SME Centre@SMF will offer services such as regulatory consultations, horizon scanning workshops, and whitepapers.

HSA will also conduct professional development programmes to improve industry understanding of evolving regulatory frameworks. The ecosystem integrates additional support in IP protection and trade facilitation, including the issuance of Certificates of Origin.

Several agile regulatory initiatives are also being housed under HSA’s HPRG Innovation Office. These include the SaMD Change Management Programme for faster updates to software-based devices, the SHARE system for streamlined digital submissions, and the Cybersecurity Labelling Scheme for Medical Devices.

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