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Singapore’s Health Sciences Authority (HSA)
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.
Significant Recent HSA Regulatory Updates
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:
- Medical Device Reporting (MDR) System: In April 2021, the HSA launched a new online system for reporting adverse events related to medical devices. The MDR system enables healthcare professionals and members of the public to report incidents of adverse events related to medical devices easily. More information on reporting adverse events in Singapore can be found here.
- New Online Classification and Grouping tools: At the beginning of 2022, the HSA stopped accepting formal classification and grouping assessment requests. To replace this process, the HSA released a few online tools to assist manufacturers with their registration questions including tools for classifying and grouping medical devices. More information on the new tools can be found here.
- Revised Fees for Medical Device Registration: In July 2022, the HSA revised its fees for medical device registration. More information on the updated fees can be found here.
- Implementation of Unique Device Identification (UDI): In July 2020, the HSA announced its plan to implement the Unique Device Identification (UDI) system for medical devices. UDI is a globally recognized system that enables the identification and tracking of medical devices throughout their lifecycle. Guidance can be found here.
- New Guidance for registering Software as a Medical Device (SaMD): In April 2022, the HSA released additional guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore. It intends to provide manufacturers with guidance related to standalone software, software embedded in medical devices, standalone mobile applications, and web-based software.
Recent Blogs on Singapore
Singapore Medical Device Regulations and Important Links
Here are some important websites and resources related to the Singapore Health Sciences Authority (HSA) and their oversight of medical devices:
- Health Sciences Authority website: The official website of the HSA provides information on the agency’s regulations, guidelines, and services related to medical devices in Singapore. https://www.hsa.gov.sg/
- Guidance on Medical Device Registration: This site provides guidance documents related to the registration process and requirements for medical devices in Singapore, including the classification of medical devices and the technical documentation required. https://www.hsa.gov.sg/medical-devices/guidance-documents
- Interactive tool for classifying medical devices: This tool allows manufacturers to classify their medical device in accordance with Singapore HSA’s regulations. https://www.hsa.gov.sg/medical-devices/registration/is-it-a-medical-device
- Interactive tool for grouping medical devices: This tool allows manufacturers to group their medical device in accordance with Singapore HSA’s regulations. https://www.hsa.gov.sg/medical-devices/registration/identifying-md-grouping
- Guidance on Clinical Investigation of Medical Devices: This document provides information on the requirements for clinical investigations of medical devices in Singapore, including the application process, study design, and reporting requirements. https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-10_safety_reporting_1mar2021.pdf
- List of Registered Medical Devices: The HSA maintains a list of registered medical devices in Singapore, which can be searched by product name, manufacturer, or registration number. https://eservice.hsa.gov.sg/medics/md/mdEnquiry.do
- ASEAN Medical Device Directive (AMDD): This website provides information on the regulatory framework for medical devices in the ASEAN region, including Singapore. https://asean.org/book/asean-medical-device-directive/
- Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines: These guidelines provide information on the requirements for the distribution and manufacturing of medical devices in Singapore, including the quality management systems required. https://www.hsa.gov.sg/docs/default-source/hprg-ald/guide-mqa-013.pdf
More Information on HSA Regulatory Requirements for Medical Devices
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