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The Singapore Health Sciences Authority (HSA) in Singapore is responsible for ensuring the safety, quality, and effectiveness of medical devices. The HSA regulates medical devices through a risk-based approach that considers the potential impact of a device on public health.
Medical device manufacturers are required to register their products with the HSA before they can be sold in Singapore. The registration process varies depending on the risk classification of the device, and manufacturers must provide evidence of the device’s safety, quality, and effectiveness.
The HSA also conducts post-market surveillance to monitor the safety and performance of medical devices in the market. The agency may require medical device manufacturers to conduct post-market studies or recall their products if they are found to be unsafe or ineffective.
In addition, the HSA provides guidance and regulations related to medical device labeling, advertising, and clinical investigations. Medical device manufacturers are required to comply with the Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards to ensure the quality and safety of their products.
In general, the HSA plays a critical role in ensuring the safety and effectiveness of medical devices in Singapore through their registration, regulation, monitoring, and enforcement of regulations and standards.
The Health Sciences Authority (HSA) is an efficient, well established competent authority and has not made any significant changes recently. However, they often release new and/or updated guidance to maintain their leading regulatory status in the region. Here is a summary of some of the key updates:
Singapore’s HSA Removes Classification and Grouping Inquiry Option
Medical Device Advertising Requirements in Asia
Singapore’s HSA To Increase Fees In July 2022
Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)
Regulatory Spotlight: UDI Requirements in Singapore
Singapore Releases New Guidance of Medical Device Software
Here are some important websites and resources related to the Singapore Health Sciences Authority (HSA) and their oversight of medical devices:
Our Overview of the Medical Device Registration Page
Singapore Medical Device Register (SMDR)
Kenna’s Regulatory Hint
“Singapore can be a tricky market to navigate due to the various registration routes available. Asia Actual can help. ”
US: +1 512 898-9222
SG: +65 8800-3197
EMAIL: inquiry@asiaactual.com
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