The Health Sciences Authority (HSA) and the Singapore Manufacturing Federation (SMF), through its Medical Technology Industry Group (MTIG), have launched an integrated regulatory support ecosystem for Singapore’s MedTech sector. This collaboration combines the SME Centre@SMF’s business advisory services with HSA’s Health Products Regulation Group (HPRG) Innovation Office to shift regulatory processes from reactive compliance to proactive guidance.
Through early consultations and structured regulatory programmes, this partnership enables MedTech innovators to navigate product development and registration more efficiently via HSA’s strategic initiatives and collaborative frameworks.
Scope
Summary of the joint initiative between HSA and SMF to strengthen regulatory support and accelerate market access for Singapore’s MedTech ecosystem.
Key Highlights
Joint Initiatives and Frameworks
- Medical Device Regulatory Reliance Programme (HSA–MDA, Malaysia)
Effective 1 September 2025 to 28 February 2026, this programme facilitates expedited registration of Class B–D medical devices across both markets. - Regional Reliance Programmes
Similar collaborations with Australia, Thailand, Hong Kong, the Philippines, and Sri Lanka, which have already achieved over 500 medical device approvals in Australia and Thailand. - Complementary Regulatory and Innovation Programmes
- Medical Device Regulatory Reliance Programme (HSA–MDA, Malaysia)
- SaMD Change Management Programme
- SHARE submission system
- Cybersecurity Labelling Scheme for Medical Devices (CLS(MD))
- ASCENT research centre with A*STAR
Enhanced Industry Support via SME Centre@SMF
SME Centre@SMF will continue to deliver targeted regulatory updates, training, consultation, and facilitate engagement between HSA, industry stakeholders, and innovators.
Leadership Insight
Adjunct Professor (Dr) Raymond Chua, CEO of HSA, emphasised that strengthening the regulator–industry collaboration ensures relevant regulations, supports innovation, maintains patient safety, and positions Singapore as a trusted global MedTech hub.
Attachment
See the full press release from the Health Sciences Authority (HSA) (provided in English). [PDF].
Effective Date
02 October 2025
Implications to Clients
This partnership marks a significant step in uniting regulator and industry to accelerate MedTech innovation, streamline compliance, and enhance access to Singaporean, ASEAN, and Asian markets.
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