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UKCA DECLARATION OF CONFORMITYThe manufacturer or his nominated representative established in the community; ROCK FALL UK LTD, WIMSEY WAY, ALFRETON, DERBYSHIRE, DE55 4LS, UNITED KINGDOM Declares that
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How to fill out annex to device listingfor

01
Obtain an updated device listing form from the appropriate regulatory agency.
02
Verify if any new devices need to be added to the listing.
03
Fill out the form with accurate and detailed information for each device being added.
04
Include any necessary documentation or supporting materials as required.
05
Submit the completed annex to device listing form to the regulatory agency for review and approval.

Who needs annex to device listingfor?

01
Manufacturers of medical devices who are required to maintain an updated listing of their devices with the regulatory agency.
02
Companies seeking regulatory approval for new medical devices that need to be added to the official listing.
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The annex to device listing is a supplementary document required for providing detailed information on medical devices that are registered for sale. It includes specific data about the device's characteristics, indications for use, and manufacturing details.
Manufacturers and distributors of medical devices are required to file the annex to device listing to ensure compliance with regulatory standards and to provide necessary details about their products.
To fill out the annex to device listing, you need to provide accurate and detailed information about the device, including its name, classification, intended use, labeling, and any other relevant specifications as required by regulations.
The purpose of the annex to device listing is to ensure that regulatory authorities have comprehensive information on each medical device, facilitating safety assessments and market surveillance.
The information required includes the device name, model number, manufacturer details, intended use, risk classification, labeling information, and any significant changes since the last registration.
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