When you make design changes to an existing medical device, requirements in most major markets indicate you must notify the regulatory authority of your change. Unlike other markets, Japan PMDA registrants must submit even minor device changes. Sometimes, manufacturers, especially foreign manufacturers, overlook requirements to submit Minor Change Notifications and/or Partial Modification Applications.
This whitepaper will identify key points for specific regulatory procedures to follow when notifying Japanese regulators of design changes to your device, as well as risks if you do not follow these submission procedures. You will learn:
- Key actions to consider for design changes
- An overview of reference guidance documents for design change notifications
- Detailed charts indicating when and how to notify PMDA
- What happens when you fail to notify PMDA of your design change
- Design change notification requirements under MDSAP
You will learn all this and more in this 15-page white paper.