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 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 including 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 a digital portal called Singapore Health Product Access and Regulatory E-System (SHARE). SHARE replaced the previous MEDICS (Medical Device Information and Communication System) portal in 2025. 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.  

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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