All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No...
Singapore Medical Device Regulatory Strategy Report
The Medical Device Branch of the Health Science Authority (HSA) oversees the medical device market in Singapore. All medical devices except Class A products must be registered with the HSA prior to commercialization in the market.
Medical device regulations in Singapore are largely based on Global Harmonization Task Force (GHTF) recommendations. If you have market approval in Australia, Canada, Europe, Japan, or the US, you may be eligible for expedited registration routes. Download our Singapore regulatory chart for an overview of the HSA medical device registration process.
Let Emergo help you evaluate the Singaporean medical device regulatory framework as it applies to your device(s).
Through our global network of in-house consultants, regulatory sources, and industry contacts, Emergo provides incisive analysis of medical device markets such as Singapore. Emergo's global regulatory strategy report service for the Singaporean medical device market covers the following topics:
- Regulatory background for the HSA
- Product assessment
- In-Country representation in Singapore
- Medical device registration requirements
- Product grouping
- Costs and timeframes
- Labeling and language requirements
- Regulatory roadmap for Singapore
We can also develop reports customized to your specifications.