The first step in the prequalification process for a male circumcision device (MCD) is the submission to WHO by the manufacturer, preferably electronically, of the application form and the requisite attachments (authorization letter and instructions for use), for review.
A completed application form provides summary information about the product, its regulatory version and the manufacturer. The details provided in this form will inform WHO in its decision on whether or not the product submitted is eligible for prequalification assessment. It is also used to determine the regulatory version intended for prequalification and to plan for each of the components of the prequalification assessment process.
The drop-down boxes below detail the information to be included in each part of the application form. The section numbers referred to are those used in the application form.
The two steps described below must be followed when submitting a prequalification application.
An electronic copy of the completed application form, instructions for use (package insert), and a letter from the manufacturer naming the person/s who is/are authorized to represent the manufacturer, must be e-mailed to: email@example.com.
A hard copy of the completed application form (including the signature of the authorized contact person for the manufacturer), instructions for use, and letter from the manufacturer naming the person/s who is/are authorized to represent the manufacturer must be posted to:
WHO Prequalification Unit: male circumcision devices
World Health Organization
20, Avenue Appia
1211 Geneva 27
Note: Manufacturers must not submit a product dossier with the application form. Dossiers that are submitted without a formal request from WHO will be returned to the manufacturer without review. Dossier submission is on invitation only.
The prequalification application form and supporting documentation will be reviewed by WHO against the established eligibility criteria to determine the product's eligibility for prequalification assessment. WHO may request additional information and/or clarifications to assist it in the eligibility decision. The manufacturer must provide WHO with the information and/or clarifications requested within the deadlines prescribed by WHO.
WHO will inform the manufacturer in writing of its decision concerning whether or not the product is eligible for prequalification assessment. If a product is found to be eligible for prequalification assessment, WHO will request the manufacturer to complete, sign and return to WHO a letter of agreement, which will serve:
- as an agreement between WHO and the manufacturer on the participation of the product in the prequalification assessment process
- the manufacturer's acceptance of, and commitment to comply with, the provisions of the prequalification assessment process.
A prequalification dossier screening and assessment fee will also be payable by the manufacturer. Assessment cannot be initiated until the manufacturer has provided a signed and completed letter of agreement, and proof of payment the applicable prequalification fee. LINK TO FEES?