Singapore: HSA Recognized Under WHO Prequalification Program for IVD Industry

On 15 June 2023, the Health Sciences Authority (HSA) of Singapore has been recognized by WHO as one of the stringent regulatory authority (SRA) for high-risk in vitro medical devices (IVD MDs), joining the other 5 countries which are European Union, the United States, Canada, Australia, and Japan.

HSA is eligible for recognition as WHO SRA due to its efficiency, safety, and high-quality stringent standards applied in health products regulatory review for the market. The qualification and standards are intended to encourage safe access to high-quality IVDs through a proper method.

The honor given by WHO assertively proves the capability of Singapore’s healthcare system in conducting high-risk IVD regulations is parallel with the principles applied by the WHO system. Previously, WHO also awarded the status of Maturity Level 4 (ML4) for Singapore for the advanced medicines regulatory system.

The SRA status also helps lots of high-risk IVD medical device manufacturers to gain acknowledgment from international purchasers and advance the movement for pre-qualification of WHO and also worldwide markets.

Source: Health Sciences Authority (HSA)

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