Post-prequalification Procedures and Fees: Prequalified MCDs
Male circumcision devices (MCDs) submitted for prequalification assessment and that meet WHO prequalification requirements are included in the WHO List of Prequalified MCDs. In order to maintain the prequalification status of a product the manufacturer must, within any applicable deadlines:
- fulfil prequalification commitments
- submit an annual report for the product
- report changes relating to the product
- meet post-market surveillance obligations
- open the manufacturing site(s) for re-inspection
- ensure the ongoing compliance of the product with WHO prequalification technical specifications.
Fulfilment of prequalification commitments
Commitments to prequalification must be fulfilled by the manufacturer within the agreed deadlines in order to keep the prequalification status of the product. Failure to meet prequalification commitments within the agreed deadlines will lead to delisting of the product(s) from the WHO List of Prequalified MCDs.
For all prequalified MCDs, the manufacturer must submit to WHO an annual report — in the format prescribed by WHO, and every year follow prequalification — that details sales data and all categories of complaints in a summarized form.
The manufacturer will receive a letter from WHO requesting submission of the annual report, together with the prescribed report format.
The report for the previous calendar year must be submitted no later than 28 February. The information provided in the annual report will inform WHO's decision on the frequency of re-inspections.
WHO prequalifies an MCD as it is submitted to and assessed by WHO at a particular point in time. To meet WHO prequalification requirements, the manufacturer must establish, maintain and implement a procedure for categorizing and documenting any changes to the product and/or the quality management system (QMS). This procedure must be available as part of the product dossier and during the inspection of the manufacturing site(s).
Changes that must be reported to WHO are as follows:
- changes to the prequalified product or its design, labelling or manufacture
- changes to the QMS under which the product was designed and manufactured
- other reportable administrative changes.
To determine whether a change to the product, including its design, labelling and manufacture, or to the QMS, requires reporting to WHO, the manufacturer should evaluate the potential effect this change may have on the safety, quality or performance of the product.
Post-market surveillance of a prequalified MCD must be undertaken in order to monitor the product's continued compliance with WHO prequalification requirements. This must include proactive collection of information on quality, safety and performance of the MCD after it has been prequalified, as well as reactive reporting for the notification and evaluation of complaints, enabling appropriate action to be taken.
Routine re-inspection is carried out to ensure continued compliance with prequalification requirements. Routine re-inspections typically take place every three and up to five years after prequalification of a product, unless an earlier re-inspection is deemed necessary by WHO.
Ongoing compliance with technical specifications
The purpose of the WHO Prequalification Technical Specifications Series is to provide technical guidance to manufacturers of MCDs seeking WHO prequalification. Manufacturers must comply with the requirements laid down in the relevant publication in this series. For products prequalified before the relevant publication is issued, a transition period will apply.
Manufacturers must comply with the relevant technical specifications as outlined in the aforementioned series within three years from their publication. Compliance will be verified during the re-inspection. Failure to do so will result in the delisting of the product from the WHO List of Prequalified MCDs.
Reporting and communication of outcomes after delisting or suspension of a product
If a prequalified product is suspended or delisted, at any time and for any reason, such suspension or delisting will not prejudice or otherwise affect WHO’s rights to use, publish, issue, share with with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (in each case, in accordance with relevant provisions of this document, including provisions regarding the protection of any commercially-sensitive information of the manufacturer) any outcomes, reports, notices and/or results — whether in draft or final form, and whether positive or negative — arising from or relating to the prequalification assessment process, including without limitation any WHO Notices of Concern, WHO Notices of Suspension, WHO information notices for users and/or manufacturer-issued field safety notices.
Change assessment fee product and payment process
WHO will review the change documentation (i.e. the completed change report form and suporting documentation) submitted by the manufacturer to determine the type and level of assessment required which, in turn, will determine whether change assessment fees are payable. When applicable, the change assessment fee is US$ 3000, paid in one instalment. The change assessment fee will contribute to cover the costs associated with the change assessmentand dissemination of the change information.WHO will issue an invoice to the manufacturer to request payment of the change assessment fee. The change assessment process will not start unless WHO has first received the full amount of the change assessment fee, as well as written evidence of the payment thereof. Failure to pay the change assessment fee within the defined timelines will result in cancellation of the change request application. Payment of the change assessment fee does not, however, guarantee that the product will be prequalified or the change accepted by
Exemption from payment of change assessment fee
The change assessment fee is applicable in certain cases. WHO does not charge fees for the assessment of administrative changes or for certain abridged reviews.
Exemption from fee payment is determined by WHO on a case-by-case basis, depending on the extent of the required assessment work. The manufacturer will be informed in writing if an exemption is applicable.
Post-market surveillance of in vitro diagnostics (2015) (also applicable to MCDs)