Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Singapore
Singapore is a small island country in South East Asia with about 4.8 million people.
In Singapore, the Health Products Act of 2007 required registration for medical devices for the first time. The responsible body is the Health Products Regulation Group (HPRG), a division of the Health Sciences Authority (HSA). Unregistered medical devices will be taken off the market in 2010. This means medical companies selling their products in Singapore should already be applying for medical device registration.
The Therapeutic Products Division (TPD) is responsible for the registration of medicines and the continual review of approved medicinal products. The Medicines Act is the main regulation, providing a comprehensive control of dealings in medicinal and its related products (Western pharmaceuticals, Chinese proprietary medicines, contact lens substances, etc.).
For more information on regulatory issues 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)
- A Regulatory Update on Asia's Smaller Medical Device Markets
- Singapore's Pharmaceutical and Medical Device Regulatory Environment: 2005 Update
- Regulatory Updates for Medical Devices in Asia (PDF)
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