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E013: Injection Devices for Therapeutic Uses

E013: Injection Devices for Therapeutic Uses

The products listed in this new section include single-use Re-use prevention (RUP) syringes for therapeutic use. All prequalified syringes in this category comply with ISO 7886-4 – Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature.

Guidelines for safe delivery of immunization injection and safe disposal of used syringes and needles can be found in WHO's Immunization in practice: Module 4: Ensuring safe injections.

The performance specification and or verification protocol for this category are currently under development by WHO IMD-PQS for this category. For guidance at the current time, manufacturers and suppliers may refer to to ISO 7886-4 – Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature.

E013 PRODUCT DATA SHEETS: Category E013 product data sheets are available for view, download and comparison here.

Syringe Prequalification Submission Guidance: Video Module 1

This module explains the revised procedural framework for immunization device prequalification. We walk through key process updates designed to help manufacturers and resellers meet current WHO performance, quality, and safety requirements to achieve and maintain prequalified status.

Link: Click on the image below.

Copy: https://www.youtube.com/watch?v=LQM_JEXDxJA 

 

 

 

 

 

 

 

 

 

 

Syringe Prequalification Submission Guidance: Video Module 2

In this second module, the focus shifts to the Application Review Template. This template serves as the primary traceability document for the entire submission process. Manufacturers, resellers, and reviewers rely on the template to support clear, complete, and successful dossier submissions and reviews.

Link: Click on the image below.

Copy: https://www.youtube.com/watch?v=GzcS9IZFAAY