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Medical labelling checklist

Medical labelling checklist

Systematically verify medical device labelling compliance with comprehensive regulatory checkpoints for FDA and international requirements.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
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or Download template as PDF
Medical labelling checklist

Systematically verify medical device labelling compliance with comprehensive regulatory checkpoints for FDA and international requirements.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

Ensure complete regulatory compliance with our medical labelling checklist template designed specifically for healthcare product manufacturers and compliance officers. This template transforms complex labelling requirements into a systematic verification process, helping you avoid costly errors and potential regulatory actions. Studies show that over 50% of medication use errors are associated with poor labels, highlighting the critical importance of thorough labelling review processes.

We created this template to help you track all required elements—from proper identification markers and warnings to language requirements and symbol usage—providing a documented trail of your compliance efforts. Use this checklist to standardize your labelling review process, train new team members, and demonstrate your commitment to patient safety through proper labelling practices.

Related categories

Created by

Author Name Inioluwa Ademuwagun
Preview of the template
Entity
Product Information
Drug/Device Name
Dosage
Expiry Date
Lot Number
Usage Instructions
Usage Instructions
Regulatory Compliance
Regulatory Compliance

Frequently asked questions

How can I ensure my medical device labelling remains compliant when regulations change?

The checklist includes a regulatory tracking section where you can document the specific standards and regulations referenced during review. Set up automated alerts for regulatory changes affecting your products, and schedule immediate reviews when new requirements are published. The template’s modular design allows you to quickly incorporate new compliance elements as regulations evolve.

How does the medical labelling checklist help with UDI compliance?

The checklist includes specific verification points for UDI placement, format, content, and durability requirements. It helps you confirm that the UDI is machine-readable, human-readable, and contains all required data elements. The template also addresses UDI database submission requirements and helps track implementation deadlines for different device classes, ensuring complete compliance with this critical identification system.

How does this checklist help with symbol usage on medical device labels?

You use the checklist to verify that each symbol meets ISO 15223-1 standards and explain them clearly in the documentation. You confirm that symbols are the correct size, clearly visible, and comply with regulatory requirements.

Author
Inioluwa Ademuwagun
Inioluwa is a freelance content writer with a passion for words and everything marketing. She has worked closely with B2B SaaS and e-commerce brands creating product-led content. She loves to read fiction and would describe herself as an introverted nerd who desires to travel around the world. She currently doing that with her words till she can with her eyes
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.