Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs)
The Health Sciences Authority (HSA) of Singapore has been recognized by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk (Class C and D) in vitro diagnostic medical devices (IVDs).
The HSA joins the five founding members (European Union, The United States, Canada, Australia, and Japan) of Global Harmonisation Task Force (GHTF) as the 6th SRA for IVDs.
This accolade is a strong testament to the HSA’s competency in high quality and vigorous scientific evaluation of IVDs.
With the SRA status, IVDs that have been evaluated and approved by HSA can obtain faster evaluation for WHO prequalification. This reduces the time required for companies to register their products in other countries, enabling IVD manufacturers accelerated speed to market access.
For further information, please refer to this link.
If you have any queries regarding the announcement, please contact us or click the button below.