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Approved by GAO U.S. NUCLEAR REGULATORY COMMISSION NRC Form 483 176 0 CFR 31 38R0160 I REGISTRATION CERTIFICATE IN VITO TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE I Section 31.11 of 10

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What is registration certificate for in-vitro?

Registration certificate for in-vitro is a document that confirms the registration of in-vitro diagnostic medical devices with the regulatory authorities.

Who is required to file registration certificate for in-vitro?

Manufacturers and importers of in-vitro diagnostic medical devices are required to file the registration certificate.

How to fill out registration certificate for in-vitro?

The registration certificate for in-vitro can be filled out online on the regulatory authority's website, with information about the device, its intended use, and manufacturer/importer details.

What is the purpose of registration certificate for in-vitro?

The purpose of the registration certificate for in-vitro is to ensure the safety and effectiveness of in-vitro diagnostic medical devices in the market.

What information must be reported on registration certificate for in-vitro?

Information such as device name, intended use, manufacturer details, risk classification, and testing data must be reported on the registration certificate.

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