Instructions for use design: understanding international regulatory guidance for multi-country product launches
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionThe output of this work is a framework for human factors practitioners to quickly compare and contrast key similarities and differences across global labelling and IFU requirements when designing items that are intended for multi-country launches.

As advances in technology and globalization accelerate, many medical device manufacturers are looking to expand to new markets to launch their products. In efforts to keep research and development costs down, companies are seeking ways to develop labeling and instructions for use (IFUs) that can be easily translated while balancing regulatory requirements across local markets with minimal required updates. As part of this effort, human factors practitioners can aid medical device manufacturers with designing and developing the instructions for use and labelling efforts by ensuring that the human factors requirements are appropriate for the intended launch market(s).

This work reviews requirements for designing instructions for use and relevant labeling for human factors submissions for medical devices adhering to local regulatory guidance from areas around the globe. This analysis was based on harmonized global standards (ANSI/AAMI HE75:2009, 2018) and relevant local regulatory guidance where available from a subset the following agencies from the International Medical Device Regulators Forum (IMDRF):

• Australia - Therapeutic Goods Administration
• Brazil - National Health Surveillance Agency (ANVISA)
• Canada - Health Canada
• China - China Food and Drug Administration
• Europe - European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
• Japan - Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare
• Russia - Russian Ministry of Health
• Singapore - Health Sciences Authority
• South Korea - Ministry of Food and Drug Safety
• United Kingdom - UK Medicines and Healthcare products Regulatory Agency (MHRA)
• United States - U.S. Food and Drug Administration

In order to effectively compare and contrast regulatory guidance for labelling and IFUs, a list of key elements was iteratively created by team members from a global human factors and user experience (UX) research consultancy that has created, iterated on, and/or tested over 100 different sets of labelling / IFU content over the last 15+ years. Key elements include recommendations for

• Symbol formatting (size, color, shape)
• Text formatting
o Font
o Headings
o Capitalization
o Language & readability
• Content recommendations
o Name of instructions
o Purpose of product
o Proper disposal of materials
o Proper storage
o Images
• Flow & organization
o Placement of specific content (e.g., warnings, purpose, etc.)
o Page layout
o Step by step instructions
• IFU format (digital, print, etc.)