HSA RECOGNISED BY WHO AS STRINGENT REGULATORY AUTHORITY FOR HIGH-RISK IN VITRO DIAGNOSTIC MEDICAL DEVICES

The Health Sciences Authority (HSA) has been recognised 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), making it one of six regulatory authorities to receive the recognition.

2. This achievement validates HSA’s stringent standards for quality, safety and efficacy. With the SRA status, IVDs that have been evaluated and approved by HSA can obtain faster evaluation for WHO prequalification. This in turn reduces the time required for companies to register their products in other countries, enabling IVD manufacturers accelerated access to global markets.

3. IVDs are tests that can detect diseases, conditions and infections by analysing samples (e.g. blood, urine, cerebrospinal fluids, tissues) collected from an individual. IVDs are regulated as medical devices under HSA, and are subject to evaluation and registration by HSA prior to supply and use in Singapore. This ensures that the tests meet appropriate standards of quality, safety, accuracy and performance when used in Singapore’s healthcare system.

4. WHO performs a similar evaluation of IVDs and prequalifies them on a global basis, especially for priority diseases (e.g. human immunodeficiency virus, Ebola, human papillomavirus). WHO prequalification is meant to promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable manner. For instance, in countries which have little or no domestic regulatory frameworks, WHO prequalification provides complementary regulatory support.

5. “The recognition by WHO is a significant affirmation of HSA’s capabilities. It demonstrates HSA’s high competencies in its regulation of IVDs and affirms its exemplary contributions to healthcare in Singapore. This achievement also goes beyond Singapore’s public health context. It greatly benefits other countries in facilitating speedy and equitable access to these critical medical devices, which in turn supports global health equity,” said Mr Ong Ye Kung, Minister for Health.

6. Dr Choong May Ling, Mimi, Chief Executive Officer of HSA, shared, “We are honoured to be recognised by WHO as a stringent regulatory authority for high-risk in vitro diagnostic medical devices. It is a strong testament to the quality and robustness of HSA’s scientific evaluation of IVDs and a reflection of our commitment to safeguard public health through safe, effective and high quality health products. HSA will continue to work closely with WHO in advancing regulatory efficiency and thereby improving global access to essential health products.”

7. HSA is one of the six SRAs for IVDs, the first authority outside the five founding members (European Union, United States, Canada, Australia and Japan) of the Global Harmonisation Task Force (GHTF) to receive the recognition. The GHTF is a voluntary group of representatives from regulatory authorities and the medical device industry. It was conceived to achieve greater uniformity between national medical device regulatory systems to enhance patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.

8. In 2022, January, HSA was also conferred the WHO Maturity Level 4 (ML4) status for its advanced medicines regulatory system¹, the highest level of attainment to a national regulatory agency for medicines regulatory excellence.

[1] https://www.hsa.gov.sg/announcements/press-release/who-ml4