The Health Science Authority or HSA is the Singaporean regulatory agency for health products, securing the national blood supply and providing scientific guidance on forensic science and medicine. It was formed in April 1st, 2001 by integrating five specialised Ministry of Health agencies: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service.
The regulatory framework that ensures drugs, medical devices and other health products are up to standards is enforced by the Health Products Regulation Group within the HSA. The group is responsible for pre-market approvals, clinical trials as well as post-market surveillance activities.
The Health Products Regulation Group is comprised of the following divisions:
- Vigilance, Compliance & Enforcement
- Audit & Licensing
Some of the most important regulations for medical devices in Singapore are:
- Health Products Act 2007
- Health Products (Medical Devices) Regulations 2010
- GN-15-R5: Guidance on Medical Device Product Registration
A full list of HSA regulations can be found here.