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Class 1 medical FDA registration-FDA registration agency

An FDA registration number is required for the export of Class I medical devices to the United States. TCT third-party testing agencies can apply for Class I medical device FDA registration and Class II exemption 510KFDA registration. For the FDA registration of Class I medical devices, such as spectacle lenses, spectacle frames, sunglasses, etc., you only need to apply for registration after paying the annual fee. For Class II medical devices, such as dental treatment equipment, surgical gloves, etc., a 510(k) pre-market assessment must be submitted before registration. Let’s follow the editor to learn more about the details of the first-class medical FDA registration.

How to register with FDA for Class 1 medical device products?

Step 1: Determine the classification of the product?

Step 2: Choose an American agent (TCT testing agency can provide American service)

The third step: registration preparation (1 type products directly to the factory registration and product listing; 2 types of products need to prepare 510 (k) documents)

Step 4: Submit 510(k) documents to FDA for document review

Step 5: Carry out factory registration and product listing

The registration process of ClassI medical devices

–Sign the contract and pay the down payment

–Apply for FDA annual fee payment, and the factory pays the FDA annual fee

-Carry out factory registration product listing

–Obtain account operation number and product listing number

–Pay the balance

–The FDA system automatically assigns the factory registration number (automatically assigned within 90 days)

Precautions for class 1 medical FDA registration:

  1. Product code confirmation needs to be judged and confirmed based on product performance, expected use, usage scenarios and other information. Wrong code selection will lead to risks such as seizure of goods, fines, and blacklisting;
  2. New domestic enterprises need to apply for Dun and Bradstreet Number (DUNS) to China Dun & Bradstreet to create a DFUF account;
  3. After successful FDA registration (medical device companies), annual fees and FURLS account information update will be required from October 1st to December 31st every year. The annual fee varies from year to year, and the official announcement of the actual degree shall prevail; the 2022 annuity is 5672 US dollars .
  4. Regarding the US FDA registration service fee, the listing fee for a type of product is about 8K. If it is the second type of product that needs to submit 510K, and the third type requires PMA pre-marketing license, the cost is positively related to the complexity of the product and the risk.

Class 1 medical FDA registration process consulting TCT third-party testing agency, FDA is a law enforcement agency, not a service agency. If someone says that they are accredited laboratories under the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories, nor so-called “designated laboratories.” The FDA, as a federal law enforcement agency, cannot engage in such things as both a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of conformity if they are qualified, but will not “designate” or recommend a specific one or several to the public.