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CERTIFICATE OFCE (IVD) NOTIFICATION Ref. No.: RP 63502018BELGIUMOrder No.: RP 61592018Date: 28/03/2018TH IS TO CERT! FY T HAT. ACCORD ING TO THE COUNCIL DIRECTIVE 98/79/ EC, OBELISK S.A. (0. E.A.R.C.)
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How to fill out ofce ivd notification
How to fill out ofce ivd notification
01
To fill out the OFCE IVD notification, follow these steps:
02
Gather all necessary information about the in vitro diagnostic device.
03
Access the OFCE IVD notification form.
04
Provide the device manufacturer's details, including name, address, and contact information.
05
Enter the device name, intended purpose, and intended use.
06
Specify the device classification according to applicable regulations.
07
Provide a detailed description of the device and its components.
08
Include information on the target population and any special handling requirements.
09
Attach the device labeling, instructions for use, and any relevant technical documentation.
10
Submit the completed OFCE IVD notification form to the appropriate regulatory authority.
11
Keep a copy of the submitted notification for reference and future updates.
Who needs ofce ivd notification?
01
OFCE IVD notification is required for any entity or individual that intends to place in vitro diagnostic devices on the market in the jurisdiction governed by OFCE (Office Français de la Conformité des Étiquettes) regulations. This includes manufacturers, importers, and distributors of such devices.
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What is ofce ivd notification?
The OFCE IVD notification is a regulatory requirement for the notification of in vitro diagnostics (IVD) to the relevant authorities to ensure compliance with health and safety regulations.
Who is required to file ofce ivd notification?
Manufacturers and importers of in vitro diagnostic devices are required to file the OFCE IVD notification.
How to fill out ofce ivd notification?
To fill out the OFCE IVD notification, you must complete the designated form, providing details about the product, manufacturer information, and compliance with applicable regulations.
What is the purpose of ofce ivd notification?
The purpose of the OFCE IVD notification is to ensure that in vitro diagnostic products meet necessary safety and efficacy standards before they can be marketed.
What information must be reported on ofce ivd notification?
Information that must be reported includes the product name, intended use, manufacturer details, unique device identifier (UDI), and evidence of compliance with regulatory standards.
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