Snapshot

The Marketing Authorization of In-Vitro Diagnostic Devices for Human Use pathway has been developed by the of Zambia.

This pathway can be used where In-Vitro Diagnostic Devices.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is All applications shall be evaluated within 180 working days from the date of receipt in the order of submission. The applicant shall be requested to provide additional data when required within 90 working days of such a request. .