FDA Registration Service

What is FDA?

The U.S. Food and Drug Administration (FDA) is a federal agency under the U.S. Department of Health and Human Services. It is responsible for the regulation of food, drugs, biological products, medical devices, tobacco products, cosmetics, veterinary drugs and other products. Widely influential in the United States and globally, FDA is known as the "guardian of public health in America". With high credibility and professional standards recognized by experts and the public, FDA has become a critical guarantee for global consumers of food and medical products.

Our Services

We provide one-stop solutions including customs clearance certification, product testing and FDA registration for products entering the U.S. market.

01
Food FDA testing, food facility registration, import and export compliance services;
02
Physical and chemical testing of drug raw materials and formulations, microbial testing, analytical method development & validation, pharmaceutical packaging compatibility study, drug stability testing;
03
Cosmetic testing, cosmetic toxicological risk assessment;
04
Medical device safety testing, EMC & FCC testing, chemical characterization, MDSAP audit, 510(k) pre-review, medical device FDA listing approval;
05
Disposable medical mask & protective clothing FDA testing;
06
Laser product safety testing, EMC & FCC testing, FDA registration;
07
Food contact material FDA testing, safety evaluation, formula assessment of food-contact adhesives, colorants and lubricants.

FDA Regulated Product Scope

We offer comprehensive compliance services including certification, testing and FDA registration for all categories of goods exported to the United States.

Food
All exported food products, including health food, drinking water, food additives and infant food
Pharmaceuticals
Drug raw materials, pharmaceutical packaging, human vaccines, prescription and over-the-counter drugs
Cosmetics
Skin care products, color cosmetics, shampoo and daily beauty products
Medical Devices
Ventilators, endoscopes, wheelchairs, thermometers, blood pressure monitors, masks and protective garments
Laser & Radiation Products
Microwave ovens, CT equipment, X-ray devices and radiation-related products
Food Contact Materials
Raw materials and components in contact with food, such as plastic, metal, ceramic, glass and wooden articles
Veterinary Products
Livestock feed, pet food, veterinary medicines and related supplies

U.S. FDA Compliance Modes

FDA compliance is mainly divided into three types: ① FDA Registration ② FDA Testing ③ FDA Evaluation

01FDA Registration

Enterprises complete self-declaration and facility registration to meet U.S. import requirements. Most FDA registrations rely on company self-guarantee without mandatory third-party testing.
02FDA Testing

Mainly for food contact material safety testing, medical device biocompatibility testing and clinical safety assessment.
03FDA Evaluation

Typical for cosmetics, focusing on label review, ingredient listing and packaging compliance assessment.

FDA FAQs

QWho issues the FDA certificate?

A

FDA registration does not issue formal certificates. Registered facilities will obtain an official registration number and an FDA acknowledgment letter signed by an authorized official, while no physical FDA certificate is provided.
QIs a U.S. Agent mandatory for FDA registration?

A

Yes. Overseas manufacturers must appoint a U.S. resident agent (individual or entity) during registration. The U.S. Agent acts as an official liaison between the applicant and the FDA for local regulatory procedures.