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Form AEC-483 1/74 10 CFR 31 U.S. ATOMIC ENERGY COMMISSION Form Approved Budget Bureau No. 38RO 160 REGISTRATION CERTIFICATE-IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section 31.11
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How to fill out in-vitro registration certificate for
How to fill out in-vitro registration certificate for:
01
Provide your personal information, such as your full name, date of birth, and contact details.
02
Include information about the in-vitro diagnostic medical device you are registering, such as its name, purpose, manufacturer, and intended use.
03
Specify the regulatory authorization obtained for the device, including any certifications or approvals.
04
Provide details about the establishment where the device is manufactured or imported, including its name, address, and contact information.
05
Include information about the product's labeling, instructions for use, and any additional documents required by the regulatory authorities.
06
Sign and date the registration certificate form to confirm the accuracy of the information provided.
Who needs an in-vitro registration certificate for:
01
Manufacturers or importers of in-vitro diagnostic medical devices who intend to sell their products in a specific country or market.
02
Distributors or resellers who handle or sell in-vitro diagnostic medical devices and need to ensure compliance with regulatory requirements.
03
Regulatory authorities who require manufacturers or importers to obtain a registration certificate as evidence of compliance with applicable regulations and standards.
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What is in-vitro registration certificate for?
In-vitro registration certificate is for ensuring that in-vitro diagnostic medical devices comply with the relevant regulations and standards.
Who is required to file in-vitro registration certificate for?
Manufacturers, importers or distributors of in-vitro diagnostic medical devices are required to file for in-vitro registration certificate.
How to fill out in-vitro registration certificate for?
The in-vitro registration certificate can be filled out online on the relevant regulatory authority's website with all the required information about the manufacturer, the device, and its intended use.
What is the purpose of in-vitro registration certificate for?
The purpose of in-vitro registration certificate is to ensure the safety and efficacy of in-vitro diagnostic medical devices for use in healthcare settings.
What information must be reported on in-vitro registration certificate for?
The information that must be reported on in-vitro registration certificate includes details about the manufacturer, device specifications, intended use, and compliance with regulatory standards.
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