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The three numbers after the successful registration of medical devices with the FDA

2023-11-27

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The mission is to assess the safety and effectiveness of medical devices before they are launched onto the market, and to ensure their safety after they are on the market. The public health goal is to enable patients and healthcare providers to have timely and continuous access to safe, effective and high-quality medical devices. 



FDA certification for medical devices includes the following types: 



The manufacturer has registered with the FDA. 



2. FDA registration of the product 



3. Product listing registration 



4. Product listing review and approval 



The FDA registration process takes 1-2 weeks (after the registered enterprise successfully pays the annual fee to the US FDA). 



FDA registration of medical devices: 



After registration is successful, there will be three numbers: 



Medical device facility registration number: Registration or FEI Number 



Owner/Operator Number 



Product registration number listing number 



First, the owner identification number, the product registration number, and the listing number can be directly cleared through customs. 



Facilities that have been registered but have not yet obtained the "Medical Device Facility Registration Number" can temporarily use this number as the "Medical Device Facility Registration Number" for export customs declaration.