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DTi is a domestic third-party testing and certification organization, provides a one-stop solution for FDA certification, with an experienced engineering/business team, With more than 12 years of testing experience, we provide a full range of testing and certification needs. Service Hotline: 139-2372-2641.

What is FDA certification

The U.S. Food and Drug Administration (FDA) for short, FDA is one of the executive agencies established by the U.S. Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA's role is to ensure the safety of food, cosmetics, drugs, biological agents, medical devices, and radiological products that are domestically produced or imported into the United States. It is one of the earliest federal agencies whose primary function is to protect consumers.

FDA classification

FDA testing of food contact materials;

FDA registration of laser products;

FDA registration of medical devices;

Cosmetics and daily necessities FDA test report;

FDA registration for food, drugs, cosmetics and daily necessities.

The difference between FDA certification and registration/testing

FDA approval: generally for more drugs, allowing drugs to be marketed;

FDA registration: The product is registered on the FDA official website first, and some products need to be tested;

FDA testing: Do testing according to FDA's published regulations to see if it complies with FDA regulations.

Note: The testing is done by a third party. The FDA itself does not do any testing. They are mainly responsible for formulating regulations and market supervision.

FDA application process

Enterprise registration: fill in the registration application form, and the FDA confirms the release of the enterprise serial number;

Product registration: Medical device products are divided into 3 categories according to the degree of safety risk:

Class 1 medical device listing control;

Category 2 Market Access Recognition (i.e. 510(k) Recognition);

Category 3 PMA pre-market approval.

Entrusted agent: "FDA Registration and Notification Entrustment Agreement" (signed by the legal representative and stamped with the company's official seal)

provide information:

Enterprise legal person business license;

Business legal person code certificate, association legal person registration certificate, etc. (copy with company seal);

Qualification certificate or production license certificate within the validity period (copy with company seal);

"FDA Registration Application Form" (one in Chinese and one in English, with the company's official seal);

Additional documents required to be submitted by FDA;

Company profile (establishment time, economic performance, technical strength, main production varieties and their performance, asset status).

Payment: Registration and listing are free, 510(K) and PMA need to be paid according to the fees published by FDA online;

Registration: After the fee is charged, the FDA will complete the registration within 60 working days;

Announcement: The FDA website announces the registration status, and the FDA of 510(K) and PMA will send another approval letter.

Service Advantage

DTi testing is an independent third-party testing organization in China. It has CNAS/CMA qualifications/technical team/has accumulated many years of experience in the field of FDA certification. It can provide you with more professional and reliable FDA certification according to the latest control requirements of FDA certification. Detection service.