Snapshot

The Registration of medical devices approved by a Stringent Regulatory Authority or prequalified by WHO/UNFPA pathway has been developed by the of Ethiopia.

This pathway can be used where In vitro diagnostic medical devices classified into Class A, B, C, and D; Class A being the devices with lowest risk and Class D being the devices with highest risk. .

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

Target time assessment is The aim of SRA/prequalified products route of application and assessment is to increase efficiencies and avoid duplication of effort and to reduce the time wasted to evaluate the products compliance with the EFDA‟s requirements by focusing on aspects where EFDA's evaluation brings added value. EFDA will review the filled information in eRIS and supportive documentation and then determine the product`s eligibility for SRA route of application. If the applicant intentionally submits misleading information (submitting a non-SRA application as SRA), that particular application will be rejected either during screening or evaluation stage. The applicants should submit all documentation required for registration of medical devices through full assessment pathway, but it takes shorter processing time as it will focus on verifying genuineness of submitted information. A product's approval by a Stringent Regulatory Authority/ prequalification provides a level of assurance relating to the quality, safety and performance in countries where the product is approved, but it may not always provide the same assurance level when the product is used in Ethiopia. Hence, whenever deemed necessary, the Authority may conduct a full assessment of the application and further information may be requested..