Medical Device Product FDA Certification & Registration Us Fda Certificate
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FDA Certification & Registration,What is FDA certification & what is FDA registration?
Amazon US sells food, masks, cosmetics and other products. In addition to considering product packaging, transportation, pricing and marketing, merchants must also obtain approval from the U.S. Food and Drug Administration (FDA). Products registered with the FDA enter the U.S. market to avoid the risk of being “taken off the shelves”
1. What is FDA?
FDA is authorized by the U.S. Congress, the federal government, and
is the highest law enforcement agency specializing in food and drug
administration. Full name: Food and Drug Administration
Strictly speaking, there is no such thing as FDA certification, as the FDA itself has said. Generally speaking, the FDA certification mainly refers to the following three types: FDA registration, FDA testing and FDA approval.
① FDA registration: Companies that export food, drugs and medical devices to the United States must register with the FDA and list the company and products. Otherwise, customs will not clear customs. This is a mandatory requirement.
②FDA testing: FDA testing refers more to the safety testing of food contact materials, testing of product contact packaging, biocompatibility testing of medical products, clinical safety testing, etc.
③FDA approval: This type of approval is generally for drugs, which means the drug is allowed to be put on the market.
2. FDA Responsibilities
Ensure the safety of food, cosmetics, medical devices, laser
radiation products, tobacco, etc. produced or imported into the
United States
3. FDA control scope
List of product categories regulated by FDA (enumeration):
Food: dietary supplements, bottled water, food additives, baby formula, pet food, etc.; Cosmetics: cosmetic color additives, skin moisturizers and cleansers, nail polish, perfume, etc.;
Medical devices: masks, prescription drugs, over-the-counter drugs, human vaccines, dental equipment, surgical implants, prosthetics, etc. Laser radiation products: microwave ovens, X-ray equipment, sun lamps, etc.;
Veterinary products: livestock feed, pet food, veterinary drugs, etc.;
Tobacco products: cigarettes, cigarette tobacco, roll-your-own cigarettes, smokeless tobacco, etc.
······
4. What is FDA registration?
FDA registration is to register companies and enterprises and
obtain a registration number.
The FDA is divided into several categories: food, medical products, drugs, cosmetics, food contact materials, etc.
5. Several categories of FDA registration
1. Food FDA registration
There are some differences with FDA registration of medical devices.
①. There is no US dollar annual fee for food to be approved by FDA.
②.Update every even-numbered years
③. There is no public query method after the food FDA registration is successful. You need to log in with a user name and password to check.
Food FDA registration steps:
Step 1: Confirm whether the product falls within the scope of FDA food control
Step 2: Choose a US AGENT
Step 3: Prepare corporate English information and product English information
After the food is successfully registered, you will get the company's registration number. The fee includes registration and US agent services. The cycle is 3-5 working days.
2. Medical device FDA registration
It includes two parts: enterprise registration and product listing.
After registration is completed, enter the corresponding registration code, query code, or company name to query relevant information on FDA.
The fee includes two aspects. One is the FDA annual fee charged by the United States. This must be paid directly to the FDA finance in US dollars. The annual fee for the next year is renewed from October 1st to December 31st each year to maintain maintenance. The validity of FDA registration and the amount of the annual fee also vary from year to year. (The annual fee for Class I medical devices is currently US$5,546, rising by hundreds of US dollars on average every year)
The other is the agency fee charged (including company registration, product registration, and US agent).
After successful registration, there will be three numbers:
①. Medical device facility registration number Registration or FEI Number
②. Owner/Operator Number
③,Product registration number Listing Number
It is most cost-effective for companies to register with the FDA from October to December each year. If you register with the FDA after October 1, the registration number can be used until the end of the next year. If you pay the annual fee for one year, the registration number can be used for 3 more months. .
The FDA registration cycle is 1-2 weeks (after the registered enterprise successfully pays the annual fee to the US FDA), it will first have the owner/operator number and the product registration number, and it can be cleared directly. Equipment that has been registered but has not yet obtained a "Medical Device Facility Registration Number" can temporarily use this number as the "Medical Device Facility Registration Number" for export declaration. Among them, Registration or FEI Number needs to wait for FDA distribution.
3. Cosmetics registration
There are two types of FDA cosmetics registration: factory registration and product registration.
Factory registration: first apply for an account, submit registration after FDA confirmation, and wait for FDA approval, which takes 2 weeks.
Product registration: The prerequisite for product registration is to first register the factory and then submit the product ingredients. The cost of ingredient registration doubles with the ingredients.
After successful registration of cosmetics, you will obtain the enterprise registration number and CPIS product ingredient registration number (cosmetic registration is similar to food, you need to check it in the background and cannot be directly queried)
4. FDA test report of food contact materials
Step 1: Conduct testing according to FDA standards and obtain a testing report
Step 2: After receiving the test report, we will serve as your company's U.S. agent and go to the FDA database to check whether the corresponding standards meet the relevant requirements of the FDA. Then those who issue a certificate of compliance will eventually obtain an FDA certificate of compliance.
6. Validity period of FDA certification/FDA registration
Cosmetics FDA
After successful authentication, it will be permanently valid.
All cosmetics sold in the United States, whether locally manufactured or imported from abroad, must comply with regulations promulgated by the Law Administration and require the development of a voluntary cosmetics registration program.
Medical Device FDA
Valid for one year, renewed every October
The U.S. Food and Drug Administration (FDA) Modernization Act requires all companies engaged in the production, formulation, dissemination, synthesis, assembly, processing, or import and export of medical devices to register with the FDA.
Laser radiation FDA
Valid for one year, renewable every July
Laser categories include: laser pointers, laser demonstrations, laser displays, products containing laser units (DVD, CD-ROM, CD players, laser printers, etc.) safety protection and rescue products.
Drug FDA
Valid for one year, renewed every October
All facilities that manufacture drugs intended for use in the diagnosis, treatment, symptom relief, treatment, or disease of disease must register with the FDA and declare all of their ingredients.
Food FDA
Renewal every even-numbered years
All U.S. and non-U.S. businesses that manufacture, process, package or store food or materials for consumption in the United States must register with the U.S. Food and Drug Administration (FDA).
6. FDA certification process:
1. The applicant signs the "FDA Registration Quotation Contract"
and fills in the "FDA Registration Application Form";
2. The applicant will stamp the application form and contract and return it;
3. Send payment notification;
4. The applicant pays the registration fee;
5. Register with FDA;
6. The applicant receives FDA registration related information (FDA registration number, password, PIN code and other relevant information)
7. Acceptance of technical preliminary review applications
8. DMF data review
9. FDA inspection
10. FDA issues “approval letter”
Medical Device Product FDA Certification & Registration Us Fda Certificate
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