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Application Submission

Application Submission

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.

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. 

2. Product information

2.1 Product name and product/catalogue number

2.1.1 Only one male circumcision device is permitted per application. Provide the name for one product only.

2.1.2 Provide the product kit size and product/catalogue number. If the product is available in multiple kit sizes, provide this information for each individual product kit size.

2.1.3 If accessories are provided with the device, provide the name and product/catalogue number for each accessory.

Note: WHO must be notified of variations made to this product after prequalification.

2.2 Current instructions for use

Provide document control details for the instructions for use documentation relevant to this product. Attach to the application form a copy of the English language version of the instructions for use (package insert).

2.3 Storage conditions and shelf-life

The storage conditions must be clearly specified by the manufacturer. Shelf-life upon manufacture is the period of time — from when the product is released for supply until the expiry date — during which the product performance is assured by the manufacturer.

2.3.1 If there are any other specified storage conditions applicable to this product, also provide details of these storage requirements.

3. Independent clinical studies

An "independent clinical study" is a study that has been carried out by an impartial centre of excellence that has no professional or personal interests in the manufacturer or the product.

Note: The manufacturer should ensure that any independent clinical study are carried out by centres that have the capability of performing scientifically sound studies for the product in question. 

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.

5. Quality management system

An effective quality management system (QMS) is a key consideration for all manufacturers of male circumcision devices (MCDs). Therefore, MCD submitted for prequalification assessment must be manufactured under an appropriate QMS. The quality management standard ISO 13485:2016 Medical devices ‒ Quality management systems ‒ Requirements for regulatory purposes is considered to be a benchmark in quality management for the manufacturers of MCDs by regulatory agencies throughout the world. WHO bases its MCD prequalification assessment and inspection process on the requirements of this internationally recognized quality management standard.

5.1.1 ‒ 5.1.6 Provide information about the manufacturer's quality management system used for the manufacture of this product.

6. ISO 13485:2016 certification

6.1.1 If the manufacturer holds ISO 13485:2016 Medical devices ‒ Quality management systems ‒ Requirements for regulatory purposes certification for the manufacture of this product, then provide details of this certification here. This certification must cover the manufacturer taking responsibility for the product, and all sites involved in the manufacture of the product.

Note: You will be required to provide evidence of all quality management system claims as part of your product dossier submission.

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.

This declaration must be completed before WHO will consider your application for WHO prequalification assessment.

Submission procedure

The two steps described below must be followed when submitting a prequalification application.

Step 1

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: diagnostics@who.int.

Step 2

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
MHP/RPQ/PQT
World Health Organization
20, Avenue Appia
1211 Geneva 27
Switzerland.

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.

Following submission

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?