The Medical Device Branch of the Health Science Authority (HSA) oversees the medical device market in Singapore. All medical devices, except certain Class A devices, 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.
Let Emergo assist you in evaluating the Singaporean medical device regulatory framework as it applies to your device(s)
Through our global network of industry and regulatory contacts as well as in-house consultants, Emergo provides incisive analysis of medical device markets such as Singapore. Emergo's Global Regulatory Overview 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
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for Singapore
Please contact us for more information about our Regulatory Overview Report for Singapore.