Regulatory Updates
HSA's SRA status for in vitro diagnostic medical devices (IVD)
Audiences
Industry member
Product type
Medical devices
16 June 2023
We are pleased to announce that HSA is now recognised as a WHO stringent regulatory authority (SRA) for high risk in vitro diagnostic medical devices (IVD).
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An SRA is a national health products regulatory authority considered by the WHO to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of health products for marketing authorization. With HSA being recognised as an SRA for Class C and Class D IVDs, these classes of IVDs registered with HSA qualify for abridged prequalification assessment by WHO. This is a significant testament of the quality and robustness of HSA’s scientific evaluation of IVDs.
HSA being recognised as an SRA for such IVDs may be beneficial to medical device companies. Major international purchasers, e.g. the United Nations agencies, rely on the listing by the WHO Prequalification Programme. Hence, IVD manufacturers that register their IVDs with HSA may be able to use HSA’s SRA status to gain expedited listing under the WHO prequalification programme, and as a springboard for faster access to various markets beyond Singapore.
HSA is committed to being a trusted and choice regulator for our stakeholders. We seek your continued support as we work to safeguard and advance public health in Singapore and beyond.