Entry checklist

Organisation and authority

• Identify the responsible organisation, manufacturer and authorised contact.
• Provide written authority if an agent is entering for someone else.
• Confirm that you may supply the reports and proposed public images.
• Use a contact who can answer questions throughout the review.

Product identity and scope

• Name the product, brand, model or formulation and relevant software version.
• Describe intended use, users and the setting.
• Identify at least one market in which the product is available for lawful supply.
• Choose one principal category and list any proposed covered models.
• Identify earlier entries and explain material changes.

Claims and evidence

• Quote each principal claim as used in product information.
• Link each claim to the relevant file, pages, product version and finding.
• Explain methods, conditions, populations and limitations as appropriate.
• Distinguish direct product evidence from ingredient, component or earlier-version material.
• Include relevant contrary findings and explain unresolved gaps.
• Complete the additional checklist for the chosen category.

Quality and use

• Supply current labelling or instructions and relevant warnings.
• Provide relevant quality, risk, maintenance and market material.
• Disclose recalls, restrictions and other material product concerns.
• Explain evidence about usability, accessibility and important user tasks.
• Describe the baseline for claimed improvements and relevant lifecycle arrangements.

Files and demonstrations

• Check that reports are legible, complete enough to assess and versioned.
• Provide English explanations and relevant translated passages where needed.
• Keep within 20 attachments and 250 MB: 25 MB per PDF and 10 MB per image.
• Use a stable video or demonstration link with limited review access.
• Remove unnecessary personal information; do not submit patient records or production credentials.

Before pressing Submit

Check the proposed public product information separately from private evidence. Confirm the rules, authority and declarations. Entry is free; no payment or sample shipment is required. Save the receipt and reference after submission.

A receipt does not mean the entry has been accepted or awarded. Reviews normally take about 90 calendar days from acceptance of a complete, eligible entry. Your account shows requests and timing.

View category guidance · Use the evidence worksheet · Enter your product