Answers to Regulation

The basic understanding regarding regulation is that each national regulatory authority has their own jurisdiction in mind when regulating a product. For instance, Most South Sahara African (SSA) countries are not interested in FDA approval as they are aware that FDA reviews the clinical data from US populations not SSA populations.  Although national registration should be mandatory, it may not be necessary to repeat the same studies in each country. There will be some similarities related to assessment of the quality system under which a product is manufactured, especially in the jurisdictions that follow GHTF guidance. The process, harmonization of registration and regulatory requirements, is an important mandate of WHO to avoid duplication and excessive costs related to registration.  Nevertheless, WHO takes the view of strengthening the capacity of countries to undertake their own national registration procedures. Therefore, it is recommended to manufacturers to submit for national registration in the country they are interested marketing in.


review of WHO policy

For a review of the WHO policy process for TB diagnostics, please see this presentation by Gilpin et al. [link]





prequalification of WHO 2

For WHO Prequalification of Diagnostics Program, see:





For the US FDA regulatory process for diagnostics, see:




health canada

For Health Canada regulatory process for diagnostics, see:




EU commision

For Conformité Européenne (CE Mark) process, see:




india medical device

For Drug Controller General of India (DCGI) regulatory approval in India, see:





For the China Food and Drug Administration (CFDA) regulatory process for medical devices, see:





For Japan pharmaceuticals and Medical Devices Agency (PMDA) regulatory process, see:





For Australia Therapeutic Goods Administration regulatory process for diagnostics, see:




SA regulation

For South Africa Department of Health regulations on medical related products, see






For Brazilian Health Surveillance Agency (ANVISA) regulation on health related products, see:


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