Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)

The 1^st draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) has been prepared to enhance timely access to WHO-prequalified products in countries, to ensure that the product in countries is the same as the one which is WHO-prequalified and to provide a model for regulatory information exchange between countries. The draft document has been updated based on the informal consultation with experts from the National Regulatory Authorities which was conducted in November 2019 during the WHO Workshop on Collaborative Registration Procedure for Diagnostics.

We are now publishing this draft to get the feedback from a broad audience of relevant government authorities, manufacturers, and other experts.

DEADLINE for submission of comment: 15 July 2020.

You could download the document directly by clicking on the following link:

Collaborative procedure for IVDs for PC

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Comment form

Please send comments to: gunlud@who.int.