Singapore Health Sciences Authority Clarifies Regulations on IVD Analyzers

To ensure that equipment used to analyze in vitro diagnostic (IVD) tests meet Singapore’s current standards for health and safety, regulators in October issued guidance to manufacturers clarifying how best to adhere to the requirements. The Health Sciences Authority (HSA) guidance, designed to boost compliance, focuses on IVD analyzers—equipment that analyzes the reaction of specimens taken from the human body.

Such analyzers are classified by regulators as either closed-system, which means they use only reagents directed by the manufacturer, or standalone, which means they can use a variety of reagents. The standalone analyzers, which can use a variety of reagents, are generally considered higher risk by regulators.

The guidance also clarifies when IVD analyzers can be grouped together by manufacturers, and when they cannot. In general, only IVD analyzers from the same manufacturer, that work in the same manner and that fit into the same risk category may be grouped together for the purpose of registration with regulatory authorities.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.