HSA Innovation Office for Medical Devices in Singapore

1. Overview

The Health Sciences Authority (HSA)'s Innovation Office in the Health Products Regulation Group (HPRG) focuses on supporting the MedTech industry through partnerships, consultations, and innovative regulatory frameworks to facilitate early access to safe and effective medical devices. Source: https://www.hsa.gov.sg/medical-devices/io

2. Partnership with Singapore Manufacturing Federation

HSA partnered with the Singapore Manufacturing Federation Medical Technology Industry Group (SMF MTIG) to create an integrated support ecosystem. This combines SME Centre@SMF services with HSA's regulatory expertise for early consultations during product development or registration, shifting from reactive compliance to proactive guidance. It also promotes awareness of HSA's agile frameworks and new initiatives. Source: https://www.hsa.gov.sg/medical-devices/io

3. Pre-Market Consultation Scheme

The Pre-market Consultation (PMC) Scheme allows seekers to consult on regulatory requirements during device development or receive feedback on dossiers before submission. This can expedite registration and enable early market access for medical devices. Source: https://www.hsa.gov.sg/medical-devices/io

4. Regulatory Reliance and Convergence

In August 2025, HSA and Malaysia's Medical Device Authority (MDA) launched a 6-month pilot of the Medical Device Regulatory Reliance Programme (1 September 2025 to 28 February 2026) for faster registration of Class B, C, and D devices. This adds to HSA's reliance programmes with Australia, Hong Kong, Philippines, Thailand, and Sri Lanka, helping companies reduce time-to-market. Source: https://www.hsa.gov.sg/medical-devices/io

5. Software as a Medical Device (SaMD) Change Management Programme

Launched in December 2024, this programme allows SaMD manufacturers to implement rapid software updates with reduced regulatory burden via pre-specified changes. Details are in GN-37 Guidance on Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD. Source: https://www.hsa.gov.sg/medical-devices/io

6. Singapore Health Product Access and Regulatory E-System (SHARE)

Launched in July 2025, SHARE transforms application submissions and product lifecycle management. It replaces extensive guidance documents with contextualised, bite-sized guidance, supports single ZIP file uploads with background processing, and continues to be enhanced based on user feedback. Source: https://www.hsa.gov.sg/medical-devices/io

7. Cybersecurity Labelling Scheme for Medical Devices (CLS(MD))

Launched in October 2024 with the Ministry of Health and Cyber Security Agency of Singapore, CLS(MD) addresses security risks in connected medical devices by promoting secure design and informed decision-making for healthcare providers and consumers. Source: https://www.hsa.gov.sg/medical-devices/io

8. Centre for Advancing Regulatory Science Research in Next-Generation Therapeutics (ASCENT)

Launched in August 2025 with ASTAR, ASCENT strengthens Singapore's leadership in evaluating novel biotherapeutics and digital technologies. It leverages ASTAR's expertise to develop capabilities in mRNA therapeutics, digital technologies, and biologics, ensuring access to safe, high-quality therapies. Source: https://www.hsa.gov.sg/medical-devices/io

9. Important Notes

Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/io