In an effort to support access to quality, safe and Performance IVDs in South Africa, SAHPRA Medical Devices Unit would like to propose Participation in the WHO Collaborative Registration Procedure (CRP)for new product registration and post-registration amendments for IVDs.
WHO CRP is a voluntary process whereby any applicant agrees to share with the WHO CRP and NRA participants the assessment reports developed during the WHO prequalification, or the applicant agrees to submit to both the WHO and NRA CRP participants the same IVD product application data package for Evaluation.
Procedure
The procedure is to be governed by a memorandum of understanding (MoU) between the NRA participant (e.g. SAHPRA) and WHO.
In South Africa, the WHO CRP will only apply to those applicants whose establishments have already been licensed by SAHPRA.
This procedure will focus on Manufacturers and distributors.
More Details can be found on the following link: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/facilitated-product-introduction/collaborative-registration-procedure/crp-for-who-prequalified-in-vitro-diagnostics
How to apply for the WHO - CRP
