National registration of manufacturers and their products is viewed as a basic regulatory requirement for any IVD. Manufacturers seeking national approval for a given IVD are generally required to supply a dossier to the appropriate national regulatory authority, describing the IVD and documenting evidence relating to the quality of the manufacturer, as well as the safety and stability of the components, including analytical studies and clinical evidence. Current regulatory oversight of IVDs in low and middle-income countries however is highly variable, and the pathways for regulatory approval are not always clearly defined.
Harmonizing regulatory processes across countries, where mutual reliance and/or recognition allows products registered in one country to be registered in another, can help facilitate national approval and registration processes. For additional information, see Improving Access to New Diagnostics through Harmonised Regulation: Priorities for Action.