Regulatory Frameworks


Regulatory oversight ensures that in vitro diagnostic medical devices (IVDs) conform to established quality and safety standards. IVDS are devices that whether used alone or in combination, are intended by the manufacturer for the in-vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes.

Regulatory requirements are in place to prevent sub-standard or poor quality technologies from entering the market and being used for patient care.

The International Diagnostics Center at the London School of Hygiene and Tropical Medicine has numerous resources on a variety of regulatory topics, including:

  • Regulation of in-vitro diagnostic medical devices
  • National and regional regulatory legislation and requirements
  • Global and regional harmonization initiatives

Where local regulatory capacity is limited, global, regional, or other national frameworks can help guide decisions on setting minimum standards, identifying candidate technologies, and registering high quality POC IVDs in country. These frameworks include (amongst others), the International Standards Organization (ISO), the United States Food and Drug Administration (US FDA), Conformité Européene (CE) marking, and WHO’s Prequalification of In Vitro Diagnostics (IVD).

These frameworks help

  • Ensure the quality, safety and performance of IVDs
  • Harmonize regulatory requirements for pre-market assessment and post-market surveillance Improve transparency of regulatory review processes
  • Facilitate exchange of regulatory information between concerned regulatory authorities and
  • Accelerate the approval of new IVDs across multiple countries with minimal duplication of effort.

The WHO Prequalification (PQ) of In Vitro Diagnostics focuses particularly on IVDs for priority diseases and their suitability for use in resource-limited settings. Attaining PQ status means that a device satisfies WHO requirements for quality, safety and performance based upon WHO’s review of a product dossier, laboratory evaluation of the product, and inspection of a manufacturing facility.  The WHO has developed numerous guidance materials, including technical guidance for manufacturers, guidance on post-market surveillance and guidance on procurement and product selection of IVDs.

Additional information about the prequalification assessment can be found here.