FDA certification

I. Introduction to FDA

The Food and Drug Administration (FDA) is one of the implementing agencies established by the US government in the Department of Health and Human Services (DHHS) and the Ministry of Public Health (PHS). As a scientific management agency, the FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biological agents, medical equipment and radiological products produced or imported by the United States. It is one of the first federal agencies to protect consumers as the primary function. FDA-certified foods, medicines, cosmetics and medical devices are safe and effective for the human body. Nearly 100 countries in the United States, only through the FDA approved materials, equipment and technology in order to commercialize clinical applications.
 

II. Classification of FDA certification

We often say that FDA certification, usually contains the following categories:

1. FDA contact for food contact materials

2. Laser product FDA registration

3. Medical equipment FDA registration

4. Cosmetics and daily necessities FDA test report

5. Food, pharmaceuticals, cosmetics and daily necessities FDA registration

3.FDA certified certificate samples

 IV. FDA Certification Frequently Asked Questions

        Question 1: Which agency is the FDA certificate issued?

        A: FDA registration is no certificate, the product through the FDA registration, will obtain the registration number, FDA will give the applicant a reply (with the FDA Chief Executive signed), but there is no FDA certificate said.

Question 2: Does FDA need to specify a certified laboratory test?

A: The FDA is a law enforcement agency, not a service organization. If someone says they are an accredited laboratory of the FDA, he is at least misleading to the consumer because the FDA has neither a public service-oriented certification body and a laboratory, nor a so-called "designated laboratory." FDA as a federal law enforcement agency, can not engage in both the referee and when the athletes. The FDA will only approve the GMP quality of the service testing laboratory, qualify a certificate of competency, but will not "designate" or recommend a particular one or more.

Question 3: Does FDA registration require an American agent?

A: Yes, the Chinese applicant must appoint an American citizen (company / association) as its agent when conducting an FDA registration. The agent is responsible for the process service in the United States and is the medium for contacting the FDA and the applicant.

5. Why companies must pay attention to export to the US FDA certification

      "Automatic detention" is the US Food and Drug Administration (FDA) on the implementation of imported food management of a major measure, in short, is the FDA announced as "automatic detention" of goods, arrived in the US port, must be the United States After the laboratory inspection, the party allowed to release into the United States sales.
       As the FDA staff less, in the face of imported food, medicine, cosmetics and other product specifications, the number of large situation, it is impossible to carry out batch inspection, but only a random check, the general sampling rate of 3-5%, spot checks If the sample is unqualified, the batch will be subject to the following conditions: If the problem found in the inspection is a general problem (such as a trademark failure, etc.), the importer may be allowed to If the problems found in the inspection are related to the quality of the hygiene, it shall not be allowed to be released or destroyed locally or returned by the importer to the exporting country (region) and shall not be transported if the inspection is carried out. To other countries (regions). In addition to sampling there is a measure, that is, for the existence of potential problems of imported products, entry must be carried out by batch inspection, rather than spot checks, this is the "automatic detention" measures, FDA announced a Product taken

   "Automatic detention", the measures can be based on the following reasons:
1. At least one sample has been found to have a significant hazard to human health, such as harmful elements, excessive pesticide residues, toxins, pathogenic microorganisms, chemical contamination, etc., in violation of the relevant provisions of low-acid canned food, Declare the approved ingredients such as pigments.
2. If there is information or historical records, or received notice from the relevant departments of other countries, indicating that a country or region of the product may be harmful to human health, and the FDA on the above sources to assess, confirm that such products in The United States may also cause the same harm, lFDA can also be announced on such products to take "automatic detention" measures.
3. Many samples have been tested for failure, but there is no obvious harm to human health, such as metamorphic odor, inclusions, labels, etc., according to the following circumstances, manufacturers, exporters or countries (regions) announced to take "Automatic detention" measures:
(l) If a manufacturer or exporter of the US product, 6 months at least three batches of goods were FDA inspection problems, be "detained", processing, and substandard samples exceeded 25% of the sample was seized, The FDA will be the manufacturer or exporter of such products to the United States to take "automatic detention" measures;
(2) If a country or region of the US products, 6 months at least 12 batches of goods were FDA inspection problems, be "detained"

6.FDA certification is currently the most professional company

     Shenzhen, the ring test is the most comprehensive FDA certification laboratory, with US agents and branch offices, can quickly offer any product FDA registration, and in the country to establish a large FDA testing laboratories, a variety of food contact Materials can be tested. Every year a large number of US exports of products because of FDA certification problems and was stuck in the customs, and even the goods were destroyed, resulting in huge losses, so if you have any export to the US business, may wish to consult the ring test professional FDA certification engineers, first help you Clear the obstacles, FDA professional contact: 4008-258-120

Seven different types of FDA certification

    FDA certification is usually divided into traditional FDA registries, FDA testing and FDA assessment

    FDA registration meaning: In order to ensure that manufacturers of products exported to the United States in line with local FDA requirements, requiring enterprises to do self-declaration guarantee process, in fact, most of the FDA registration did not go through third-party testing, but the enterprise itself.

    FDA testing: FDA testing more refers to the safety of food contact materials testing, medical products, biocompatibility testing, clinical safety testing.

    FDA assessment: to cosmetics, for example, mainly to assess the packaging and composition notes.