Attaining prequalification is challenging for some manufacturers given the rapidly evolving medical devices landscape and increasing regulatory requirements, WHO can, however, provide advice on meeting prequalification requirements and, in some cases organize specialized technical assistance if the product in question is needed urgently by countries and procurers.

Technical advice

Technical advice can be sought at any time in relation to any product that is eligible for prequalification. Advice can be provided as a written response or during a meeting (e.g. in videoconference or one-to-one).

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Pre-submission meetings

Pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicines assessors who will be involved in assessing their product.

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Specialized technical assistance

WHO provides specialized technical assistance to manufacturers of in-vitro diagnostic medical devices (IVDs) which are of interest to WHO and other UN agencies.

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