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22 March 2021MEDICAL DEVICE GUIDANCE GN24: Guidance on the Change of Registrant Revision 1.4MEDICAL DEVICE GUIDANCE March 2021CONTENTS PREFACE ........................................................................................................
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How to fill out medical device guidance
How to fill out medical device guidance
01
Review the specific guidance document provided by the regulatory agency.
02
Identify the applicable sections related to your medical device.
03
Follow the instructions and recommendations provided in the guidance document.
04
Provide all required information and documentation as outlined in the guidance.
05
Submit the completed guidance document along with your medical device application.
Who needs medical device guidance?
01
Manufacturers of medical devices who are seeking regulatory approval for their products.
02
Regulatory consultants who assist companies in navigating the approval process.
03
Healthcare professionals who want to understand the regulations governing medical devices.
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What is medical device guidance?
Medical device guidance is a document issued by regulatory agencies to provide instructions, recommendations, or policy on the use and regulation of medical devices.
Who is required to file medical device guidance?
Manufacturers, importers, and distributors of medical devices are required to file medical device guidance.
How to fill out medical device guidance?
Medical device guidance can be filled out by providing detailed information about the device, its intended use, regulatory compliance, and any adverse events.
What is the purpose of medical device guidance?
The purpose of medical device guidance is to ensure the safety, effectiveness, and quality of medical devices for patients and healthcare providers.
What information must be reported on medical device guidance?
Information such as device description, intended use, risk assessment, clinical data, labeling, and post-market surveillance must be reported on medical device guidance.
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