Important information for prospective applicants

One dossier must be submitted for EACH product. If the product is manufactured at more than one manufacturing site, one dossier must be submitted for EACH manufacturing site.

Applicants must additionally demonstrate that the product complies with the complete list of required specifications provided in the relevant WHO IMD-PQS Performance Specification and associated Verification Protocol(s), included in the information pack that the applicant will receive from the IMD-PQS Secretariat in the case of a favorable response to a pre-submission.

In addition to the documentation and information provided in the application dossier, applicants may be required to test products using one of three types of laboratory testing, and/or field testing.

All documents submitted as a part of the application must adhere to file name conventions as described in Annex 3 of the WHO IMD-PQS Guidelines for Prequalification Holders, and in the prequalification information pack.

Generic list of supporting documents required for a prequalification application

To be submitted via the WHO ePQS portal:

• Completed Application Review Template, including the required indications that the product successfully meets the category and product criteria as set out in the relevant Product Specifications and Verification Protocols. Application Review Templates are provided in the drop-down menus at the bottom of this page.
• Cover letter, in English, expressing interest in participating in  WHO prequalification and confirming that the information submitted in the product dossier is "true and correct".
• A comprehensive set of photographs including a three-quarter view of the product, external surfaces of the unit, and interior layout (where relevant).
• Certified copies of all type-approvals obtained for the product and/or its components, including CE marking and similar.
• Certified copies of the legal manufacturer's ISO certificates, as specified in the relevant WHO IMD-PQS performance specification(s).
  • If you are a product reseller applying for prequalification, you must provide your own ISO certificated and those of the original product manufacturer as well.
• Laboratory test report(s) proving conformity with the relevant WHO IMD-PQS performance specification(s) and verification protocol(s).
• Signed copy of the WHO IMD-PQS Terms & Conditions.
• IF REQUIRED - Field testing report(s) according to the relevant WHO IMD-PQS verification protocol(s).
• IF REQUIRED - Details of the compatible solar power system, according to the relevant WHO IMD-PQS performance specification(s).

In addition, to be sent by postal / delivery courrier:

• IF REQUIRED - Production-run products for testing, as per the relevant WHO-IMD PQS equipment performance specification: categories E006, E008, E010 and E013 only.

Application Review Templates

The IMD-PQS Application Review Template is a Microsoft Excel (.xls) document intended to collect and record and track information about the products compliance with each of the required product specifications as laid out in the relevant product specification, and the communication exchanges between the applicant and the IMD-PQS Secretariat that will take place throughout the dossier review process.

The IMD-PQS Secretariat will provide the relevant template(s) to applicants via the WHO ePQS platform if, following pre-submission, the Secretariat deems the product or device eligible for prequalification evaluation.

The Application Review Templates for each sub-category of product are available for download in the drop down menus here below: