HSA (Health Sciences Authority)
The Health Sciences Authority (HSA) is Singapore’s health regulatory agency under the Ministry of Health, established in 2001. It is responsible for regulating a wide range of health products, including medicines, medical devices, cell and gene therapies, cosmetics, and complementary health products.
Singapore · HSA
Singapore HSA: How to Choose a Device Route
HSA is Singapore’s Health Sciences Authority.
Open the video guideWhat you’ll learn
- HSA is Singapore’s Health Sciences Authority.
- For registered devices, the evaluation route considers risk class, relevant reference approvals and safe marketing history.
- Use HSA’s SHARE system and current guidance for the transaction.
Read the video transcript
Already have an overseas approval and want to launch in Singapore? That approval may help, but first you need to understand how HSA chooses a medical-device evaluation route.
HSA is Singapore’s Health Sciences Authority. For medical devices, its work includes product registration, dealer licensing and safety oversight throughout the product lifecycle.
Start with the device’s intended purpose and risk classification. The technical file should make clear what the product does, who uses it and what supports its safety and performance.
Singapore uses classes A, B, C and D. Class A is exempt from product registration, but manufacturers and importers still need the required product notification. Classes B through D require registration.
For registered devices, the evaluation route considers risk class, relevant reference approvals and safe marketing history. An eligible prior approval may support an abridged or other qualifying route.
Compare the approved product and intended use with the version you plan to submit in Singapore. A similar name on a certificate does not prove that the scope matches.
Use HSA’s SHARE system and current guidance for the transaction. Also clarify the local registrant, relevant dealer licenses and the responsibility for changes and safety reporting.
The practical starting point is classification, route eligibility and local responsibilities. Our HSA glossary connects those questions with Singapore’s official guidance and market-entry resources.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
The Health Sciences Authority (HSA) is Singapore’s health regulatory agency under the Ministry of Health, established in 2001. It is responsible for regulating a wide range of health products, including proprietary and traditional medicines and pharmaceuticals, medical devices, cell and gene therapies, cosmetics, tobacco, and supplements. In addition to health products regulation, HSA oversees a number of essential activities to ensure public health, such as maintaining Singapore's blood supply in hospitals and clinics, performing forensic DNA testing, and compliance testing for various health products, tobacco and cigarettes, controlled substances, and more.
HSA regulates medical devices in Singapore throughout the device life cycle. Key medical device regulations enforced by HSA include the Health Products Act (HPA) and Health Products (Medical Devices) Regulations 2010. Its regulatory oversight activities include pre-market evaluation of health products, post-market monitoring of adverse events and recalls, issuing appropriate licenses to manufacturers, importers, and distributors, and carrying out inspections to verify compliance with Good Manufacturing Practices (GMP) and international quality standards. In addition, the authority plays a role in regulating health product advertising, monitoring product labeling, and controlling imports and exports through coordination with customs authorities.
When was the HSA established?
HSA was established as a statutory board on 1 April 2001. It was formed by merging five specialized agencies under the Ministry of Health.
Does HSA charge fees?
Yes. HSA charges fees for product registrations, change notifications, dealer licensing, free sale and export certificates, pre-market consultations and special access routes, including priority review. Fee schedules are periodically reviewed and updated and published on HSA's official website.
How does HSA manage regulatory submissions?
HSA manages medical device regulatory transactions through the Singapore Health Product Access and Regulatory E-System (SHARE). SHARE replaced the previous MEDICS portal in 2025. Use HSA's official SHARE medical device page for current access and supported transactions. Applicants must set up access through Singapore's Corppass system before submitting any applications via SHARE.
How do I contact HSA?
HSA's Health Products Regulation Group (HPRG) can be contacted via their feedback form or by phone at (65) 6866 1111. For general inquiries, HSA can be reached at HSA_Info@hsa.gov.sg.
Website: HSA
Address: Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, #11-01 Helios, Singapore, 138667
Phone: (65) 6866 1111
Email: hsa_info@hsa.gov.sg
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