Who Regulates?

Regulation of medical products is undertaken by National Regulatory Agencies (NRA) who are mandated by law to protect public safety.

In most but not all countries there is legal framework for the control of medical commodities such as medicines, vaccines and medical devices which includes medical diagnostics.

The mandate of National Regulatory Authorities is to protect the health of the population but they also have a duty to ensure the population has access to beneficial new medical products without undue delay.

Examples of NRA include

  • The Australian Therapeutic Goods Administration TGA
  • The Canadian Therapeutic Products Directorate TPD
  • The National Agency for Food and Drug Administration and Control  (Nigeria) NAFDAC
  • The Tanzania Food and Drugs Administration TFDA
  • The US Food and Drug Administration US FDA

Before approving the registration of a new in vitro diagnostic device the NRA will review a dossier of evidence submitted by the manufacturer or their agent/distributor. NRA may also review data obtained during post-market surveillance.

©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics