Partnership with the Singapore Manufacturing Federation (SMF)
HSA’s Health Products Regulation Group (HPRG) Innovation Office partnered with SMF's Medical Technology Industry Group (SMF MTIG) to provide an integrated support ecosystem for Singapore's MedTech industry, with the strategic combination of the SME Centre@SMF's services and HSA’s HPRG Innovation Office's technical regulatory expertise.
This dual-pronged approach transforms the regulatory journey from reactive compliance to proactive guidance, by offering early consultations during product development or registration. It also promotes awareness to HSA’s agile frameworks and new regulatory initiatives This enables MedTech companies to receive expert guidance during the critical early stages of product development and regulatory planning, potentially streamlining and expediting their path to access to both Singapore and other international markets.
Pre-market consultation scheme for medical devices
Under the Pre-market Consultation (PMC) Scheme, you can seek consultation on regulatory requirements during the medical device development or seek feedback on your device dossier before submission to us. This may expedite device registration and facilitate early access of medical devices. For more information on the PMC scheme, click here.
Regulatory reliance and convergence
HSA has a Medical Device Regulatory Reliance Programme between Medical Device Authority (MDA) of Malaysia and HSA. Signed on 22 August 2025, the Medical Device Regulatory Reliance Programme with Malaysia runs from 1 September 2025 to 28 February 2026, facilitating faster registration processes for Class B, C and D medical devices.
In addition to the above, HSA has also established reliance programmes with Australia, Hong Kong, Philippines, Thailand, and Sri Lanka, which companies can tap on to reduce time-to-market in these markets.
Software as a Medical Device (SaMD) Change Management Programme
Launched in December 2024, this programme enables manufacturers of SaMD to implement rapid software updates with reduced regulatory burden through pre-specified changes. For more information on the programme, please refer to GN-37, our published guidance document on Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD.
Singapore Health Product Access and Regulatory E-System (SHARE)
Launched in July 2025, SHARE has transformed how companies submit applications and manage their products throughout the lifecycle. The platform replaces hundreds of pages of guidance documents with contextualised, bite-sized guidance tailored to specific user needs. It also supports single ZIP file upload with background processing, eliminating the need for multiple individual file uploads resulting in significant time saving. HSA continues to enhance the platform based on user suggestions and ongoing stakeholder engagement.
Cybersecurity Labelling Scheme for Medical Devices (CLS(MD))
Launched in October 2024 in collaboration with the Ministry of Health and Cyber Security Agency of Singapore, CLS(MD) addresses critical security risks in connected medical devices. This scheme aims to enhance cybersecurity in connected medical devices, by promoting secure design practices and informed decision-making by healthcare providers and consumers.
Centre for Advancing Regulatory Science Research in Next-Generation Therapeutics (ASCENT)
Launched in August 2025 in collaboration with A*STAR - Agency for Science, Technology and Research, ASCENT strengthens Singapore's position as a global thought leader in evaluating and approving novel biotherapeutics and digital technologies, enabling patient access to safe, high-quality, and cost-effective therapies. Through ASCENT, HSA will be leveraging A*STAR's multi-disciplinary expertise to develop advanced regulatory science capabilities in three critical areas: mRNA therapeutics, digital technologies, and biologics.