Snapshot

The Accelerated Registration for IVDs through CRPs pathway has been developed by the of Tanzania.

This pathway can be used where Covers medical devices, including IVDs, implants, and high-risk devices. Focused on evaluating: Analytical and clinical performance. Local relevance and safety. Expedited review for products addressing urgent public health needs. Applies to new and imported medical devices, as well as locally manufactured products seeking market authorization. A medical devices are considered to be low risk devices, and Class D are high risk devices. Invitro diagnostic devices since they don’t come in contact with the patient and they achieve their functions by detecting the presence of infection from the sample which have corrected from human or animal, their main risk once used is the implications of the results they produce. Diagnostic devices that give test results of a diseases which have low personal risk and low public risk of propagation of those diseases are in Class A, while the ones which detect the presence of infection of a diseases which have high personal and public health risks are in Class D. Classification rules of medical devices and Invitro diagnostic devices are stipulated under Annex I of Medical Devices Registration Guidelines and Invitro Diagnostic Guidelines..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .