Medical Product Registration in Singapore
The Singaporean medical regulatory system is generally industry-friendly. The government there, however, is currently trying to increase safety standards by expanding the range of medical products it reviews and approves.
The Singaporean regulator of medical devices and pharmaceuticals is the Health Sciences Authority (HSA). Until recently, only pharmaceuticals needed HSA approval, not medical devices. However, the recent Singapore Health Products Act of 2007 will require HSA product approval for all medical devices starting in 2011.
The Therapuetic Products Division of the HSA is responsible for reviewing and approving pharmaceuticals and medical devices. Under this division, there is a Pharmaceuticals & Biologics Branch and a Medical Device Branch.
Registration of Medical Devices in Singapore
Registration of Pharmaceuticals/Drugs in Singapore
PBM's expertise will help you navigate the Singaporean regulatory system, achieve medical product registration, and access Singapore's large medical markets. PBM will help you register your medical product in a cost-effective and timely way.
For more information on medical product registration in Singapore, please see the following PBM publications and/or contact us to discuss your specific needs.
- Looking East for R&D and Clinical Trials
- Updates on Singapore's Medical Device Regulations (webcast for sale)
- ASEAN Medical Device Harmonization Trends (webcast for sale)
- Singapore's Pharmaceutical and Medical Device Regulatory Environment: 2005 Update
- A Regulatory Update on Asia's Smaller Medical Device Markets
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