Product dossier: prequalification of in vitro diagnostics programme

Review prequalification eligibility and scope

Confirm the programme accepts your device type and intended use.

Confirm device classification and intended use

State clinical purpose, specimen type, and target population.

Collect existing regulatory approvals and certificates

Include national approvals, CE marks, or equivalent evidence.

Assemble the device technical file

Gather device description, drawings, and design rationale.

Describe manufacturing process and quality controls

Summarize production steps, controls, and in-process checks.

List raw materials, suppliers, and critical components

Name key suppliers and specifications for critical inputs.

Compile analytical and clinical performance data

Include sensitivity/specificity, study summaries, and methods.

Summarize stability, storage and shelf-life testing

Provide conditions, expiry, and supporting test results.

Prepare labeling and instructions for use (IFU)

Include user-friendly IFU, intended audience, and local languages.

Document the quality management system

Provide ISO certificates or written QMS procedures.

Include manufacturing batch records and lot-release criteria

Attach example batch records and release test results.

Prepare risk management and safety documentation

Add risk analysis, mitigation, and residual risk statements.

Compile a post-market surveillance and vigilance plan

Outline how you will monitor and report performance after launch.

Create a clear dossier index and document map

List files, sections, and page references for reviewer ease.

Perform an internal completeness and quality check

Verify all signatures, dates, and required attachments are present.

Submit the dossier to the prequalification programme

Follow the programme’s submission portal and file format rules.

Confirm receipt and track the review timeline

Record reference numbers and expected response dates.