Application Submission

1. Manufacturer information

1.1 Manufacturer

For the purpose of male circumcision devices (MCDs) devices prequalification, WHO uses the following definition of "manufacturer": "any natural or legal person with responsibility for design and/or manufacture of an MCD with the intention of making the MCD available for use, under his or her name; whether or not such a medical device is designed and/or manufactured by that person him- or herself or on his or her behalf by another person(s).

Note: The person or company who represents themselves as the manufacturer on the product label, is the legal manufacturer for the product, even if that person or company organizes for another party to carry out manufacturing tasks on their behalf. However, the original equipment manufacturer must be disclosed. WHO accepts only MCD prequalification applications directly from the manufacturer.

1.1.1 When answering questions relating to the manufacturer, provide details for the entity that meets the above WHO definition of a manufacturer. This manufacturer is responsible for the product that is the subject of this WHO prequalification application.

1.1.2 When a manufacturer applies for prequalification of an MCD for the first time, the manufacturer is assigned a three-digit manufacturer identification number. If this manufacturer has previously had a manufacturer identification number assigned, this number should be entered in this sub-section. If this is the first prequalification application for this manufacturer, then "000" should be entered.

1.1 3 If the responsible manufacturer is owned by another company, the name of the parent company should be provided here.

Note: If WHO agrees to proceed with prequalification assessment for this product you will be required to provide detailed manufacturing information, such as the actual sites for production, quality control, assembly, labelling, etc., as part of your product dossier submission. If this product is subsequently prequalified, only the production sites detailed in the application form and the dossier submission will be considered to be prequalified.

1.2 Authorized contacts for the manufacturer

The "authorized contacts for the manufacturer" are two people explicitly designated by the manufacturer to represent that manufacturer for the purposes of the WHO prequalification process. These two authorized representatives will be the primary contact points for WHO in relation to this prequalification application. Therefore, please ensure that all contact details provided are current. WHO suggests that the manufacturer should ensure that the product manager/marketing and the technical/manufacturing functions of the manufacturer are covered by the two selected authorized contacts. A letter from the manufacturer stating that these two people are authorized to represent the manufacturer for the purposes of prequalification must be attached to the pre-submission form. 

4. Commercial and regulatory status

4.1 Regulatory status of product

4.1.1 Provide details of all current regulatory approvals for this product.

4.1.2 A regulatory authority (sometimes also called a "competent authority") is a government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with legal requirements. "Regulatory approval" means that the regulatory authority officially permits supply of this medical device in the country/region under its authority. "Type of regulatory approval" refers to the relevant sections of the legislation that have been applied to the product for regulatory approval. Generally the details of the legislation applied for regulatory approval should be included on the certificate that demonstrates that the product is approved for supply.

Note: Do not include certification information relating to ISO 13485:2016 Medical devices ‒ Quality management systems ‒ Requirements for regulatory purposes here. Questions relating to ISO 13485:2016 are addressed in Section 8 of the application form.

4.2 Commercial agreements

WHO recognizes that certain companies purchase finalized or semi- finalized products from other manufacturers and then "re-brand" these products to represent themselves as the manufacturer.

In line with the WHO definition of a manufacturer, a "re-branded" product is the responsibility of the persons who represents themselves as the manufacturer on the product label, even though they may have limited control over the actual activities carried out by the original manufacturer.

WHO considers a "re-branded" product to be one that is identical in every respect to the product manufactured by the original manufacturer, except that the product is labelled to represent the "re-brander" as the manufacturer, and/or is labelled with a "re-branded" product name and identifier.

While such arrangements may increase the commercial reach of the original product manufacturer and the "re-branded" manufacturer, they do introduce the risk that testing facilities, who are not aware of the "re-branded" status of a product, may use identical products in their testing algorithms for initial and confirmatory testing.

To minimize this risk, WHO has made the decision to give original product manufacturers priority to enter the prequalification assessment scheme. Prequalification applications for "rebranded" products will be considered on a case-by-case basis and may not be accepted for prequalification assessment if the original product has already undergone prequalification.

In all situations where WHO does agree to undertake prequalification assessment for a "rebranded" product, the original product manufacturer and the "re-branded" product manufacturer must know that WHO will disclose this commercial arrangement.

7.1.1 List all sites that are involved in the manufacture of this product. Include all stages of manufacture (e.g. design, production, warehousing, quality control and release for supply).

Note: List all stages of manufacture, including the manufacturing activities that are located at the site of the responsible manufacturer (see section 1.1 for the definition of the responsible manufacturer). If your product is successfully prequalified, only product manufactured at the sites that have been presented in this application form will be considered to be prequalified.

7.2.1 List all key suppliers which supply products/components/services for the manufacture of this product.

Note: WHO must be notified of all variations made to this product. This includes changes of key suppliers and products/components/services provided by key suppliers.