Snapshot

The Registration of medical devices including in-vitro diagnostics under WHO Collaborative Registration Procedure (CRP) pathway has been developed by the of Nigeria.

This pathway can be used where medical devices including in-vitro diagnostics under WHO Collaborative Registration Procedure (CRP).

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 1. The applicant submits the application for national registration of the WHO prequalified IVDs and non-IVDs to NAFDAC and informs the authority of its interest in following the Procedure by completing the expression of interest reproduced in Appendix 3, Part A. If the applicant for national registration is not the same as the WHO PQ holder, the WHO PQ holder confirms to the NRA and WHO/PQT by an authorization letter (as per the form annexed to Appendix 3, Part A) that the applicant is acting for, or pursuant to rights derived from, the WHO PQ holder and that the PQ holder agrees with the application of the Procedure in the country concerned. 2. The WHO PQ holder/applicant informs WHO/PQT about the submission of its application to the NAFDAC (by providing a copy of completed Appendix 3, Part A) and, for each product, provides WHO/PQT with its written consent to share the product-related information and documentation, under confidential cover, with NAFDAC. The WHO PQ holder completes and signs the consent form reproduced in Appendix 2 and submits it to WHO/PQT. 3. NAFDAC will inform WHO/PQT and the applicant of its consent to apply the Procedure to the application for registration of the product, on the understanding that the application is accepted as complete, or of its refusal by completing and signing Part B of Appendix 3. 4. Within 30 calendar days of receipt of the WHO PQ holder’s consent, WHO/PQT will provide NAFDAC with product-related information and documentation, and provides additional explanations, if requested, through the restricted-access website, and subject to the obligations of confidentiality and restrictions on use in place between WHO/PQT and NAFDAC. 5. NAFDAC will use the product-related information and documentation provided by WHO/PQT and by the applicant, at its discretion, to come to its conclusion about national registration and makes its decision on the registration within 60 working days (≈ 90 calendar days) of regulatory time. 6. Within 20 working days (≈30 calendar days) of having taken its decision, NAFDAC will informs WHO/PQT and the applicant of this decision, together with an indication of the dates of submission and registration and, if applicable, any deviations from the WHO PQ conclusions and the reasons for such deviations, through the restricted- access website. This report is provided to WHO/PQT by completing Part C of Appendix 3..