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Medical DevicesPost Market Surveillance Application FormDirective NSAI File numberMDD (93/42/EEC) 252.___.___ AIMD (90/385/EEC) 253.___.___ MDR (2017/745) 745.___.___This NSAI post market surveillance
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How to fill out medical devices significant change

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How to fill out medical devices significant change

01
Step 1: Start by gathering all necessary information about the significant change in the medical device.
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Step 2: Identify the exact nature of the change and determine whether it qualifies as a significant change.
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Step 3: Review the regulations and guidelines provided by the relevant regulatory authorities to understand the requirements for filling out the significant change form.
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Step 4: Fill out the significant change form accurately and completely, providing all required information and supporting documentation.
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Step 5: Double-check the form for any errors or missing information before submitting it.
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Step 6: Submit the filled-out significant change form to the appropriate regulatory authority according to their specified submission process.
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Step 7: Await feedback from the regulatory authority regarding the acceptance or rejection of the significant change.
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Step 8: If the change is accepted, update the necessary documentation and proceed with implementing the change in the medical device.
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Step 9: If the change is rejected, carefully review the feedback provided by the regulatory authority and make the necessary modifications before resubmitting.

Who needs medical devices significant change?

01
Manufacturers of medical devices who are planning to make significant changes to their products need to fill out the medical devices significant change form.
02
Regulatory authorities require the submission of the significant change form as part of the approval process to ensure the safety and effectiveness of the modified medical device.
03
Healthcare professionals and patients who rely on medical devices also benefit from the significant change process, as it helps maintain the quality and reliability of the devices they use.

What is Medical Devices Significant Change Application ... Form?

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Medical Devices Significant Change Application ... template instructions

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A significant change in medical devices refers to alterations that could affect the safety, effectiveness, performance, or intended use of the device. This may include modifications in design, materials, manufacturing processes, labeling, or indications for use.
Manufacturers, importers, and distributors of medical devices are required to file a notification of significant change, ensuring compliance with regulatory requirements.
To fill out a medical devices significant change, manufacturers must complete the official form provided by the regulatory authority, including details about the change, its impact on the device, and any supporting data or documentation.
The purpose of filing a medical devices significant change is to inform regulatory authorities about modifications that may impact the device's safety and effectiveness, ensuring ongoing compliance with regulatory standards.
Reported information should include a description of the change, rationale for the modification, potential effects on device performance, and any necessary supporting documentation.
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