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FDA certification
I. Introduction to FDA
The Food and Drug Administration (FDA) is one of the implementing agencies set up by the U.S. government in the 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 foods, cosmetics, pharmaceuticals, biologics, medical devices and radiological products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function. FDA-approved foods, medicines, cosmetics and medical devices are safe and effective for the human body. In nearly one hundred countries such as the United States, only FDA-approved materials, devices, and technologies can be used for commercial clinical applications.
Two .FDA certification classification
We often say that the FDA certification, usually contains the following categories:
1. Food contact materials FDA testing
2. Laser product FDA registration
3. Medical Devices FDA registration
4. Cosmetics and daily necessities FDA test report
5. Food, Drugs, Cosmetics and Daily Use FDA Registration
Three .FDA certified certificate samples
Four .FDA certification FAQ
Question 1: FDA certificate issued by which agency?
A: The FDA registration is without a certificate, the product will register with the FDA, and the registration number will be obtained. The FDA will give the applicant a reply (signed by the FDA administrator), but no FDA certificate exists.
Question two: FDA need to specify the certification laboratory testing it?
A: The FDA is a law enforcement agency, not a service agency. If anyone says they are accredited laboratories under the FDA, then at least they mislead the consumer because the FDA has neither a public service certification body nor a laboratory nor a so-called "designated lab." The FDA, as the federal law enforcement agency, can not do such a thing as a judge or an athlete. The FDA will only certify the GMP quality of service testing labs and will issue a certificate of eligibility but will not "designate" to the public or recommend a particular family or agencies.
Question three: FDA registration must necessarily require an American agent?
A: Yes, Chinese applicants must nominate a U.S. citizen (company / community) as their agent for FDA registration. The agent is responsible for the process services in the United States and is the medium through which the FDA and the applicant can be contacted.
V. Why companies must pay attention to the FDA export certification of the United States
"Auto detainment" is a major measure administered by the U.S. Food and Drug Administration (FDA) on imported foodstuffs. In short, the goods that the FDA has declared as "automatic detainment" must arrive in the United States After passing the laboratory test, Fang will allow the release into the United States for sale.
Due to the small number of FDA personnel, it is impossible to carry out lot-by-lot inspection in the face of large quantities and large quantities of imported food products, medicines and cosmetics. Only 3-5% of the samples can be spot-checked. The spot-check sample If the sample is unqualified, the batch of products will be "detained" and disposed of. If the problems found in the inspection are general problems (such as trademark unqualified, etc.), the importer may be allowed to If the problems found in the inspection are related to the quality of hygiene, they are not allowed to be released or destroyed locally or transported back to the exporting country (region) by the importer and shall not be transhipped To other countries (regions) .In addition to spot checks there is a measure that the potential problems of imported products, customs clearance must be carried out when the inspection, rather than spot checks, which is the "automatic detention" measures, the FDA announced the right of a Product to take
The "automatic detention" can be based on the following reasons:
1. At least one sample found to be significantly harmful to human health, such as harmful elements, excessive pesticide residues, the presence of toxins, pathogenic microorganisms, chemical contamination, etc., violate the relevant provisions of low-acid canned food, or contain Declared the approved ingredients such as pigments.
2. If there is information or historical records, or received notice of the relevant departments of other countries, indicating that a country or region of products may cause harm to human health, and the FDA to assess the above sources to confirm that such products in The United States may also cause the same harm, Tony | lFDA also announced the automatic detention of such products, measures.
3. A number of samples tested failed, but no obvious harm to human health, such as deterioration of smell, inclusions, labeling unqualified, according to the following circumstances were the manufacturer, exporter or country (region) to declare to take "Automatic detention" measures:
(l) If a manufacturer or exporter exports to the United States product, 6 months at least three batches of the FDA inspection found problems, to be "detained", handled, and unqualified samples more than 25% of the samples were seized, The FDA will take "automatic detention" of such products exported to the United States by the manufacturer or exporter;
(2) If a country or region exports to the United States, 6 months at least 12 batches of the FDA inspection found problems, be "detained"
VI. FDA certified to do the most professional company
Shenzhen Central Granville detection is the most comprehensive FDA certification laboratory, with the United States agents and branches, FDA can quickly offer any product registration, and in the country established a large FDA testing laboratories, a variety of food contact Materials can be tested. Every year a large number of exports to the United States because of FDA certification issues stuck in the Customs, and even the goods were destroyed, causing huge losses, so if you have any exports to the United States business, may wish to ring ring Viagra professional FDA certified engineers, to help you Clear the obstacles, FDA professional contact: 4008-258-120
Seven .FDA certification of several types of distinction
FDA certification is usually divided into traditional FDA registration, FDA testing and FDA evaluation
FDA Registration Meaning: In order to ensure that the manufacturer's products are exported to the United States in line with the local FDA requirements, companies are required to declare the guarantee process. In fact, most of the FDA registrations have not been tested by a third party, but the company itself guarantees.
FDA testing: FDA testing refers more to the safety of food contact materials testing, biocompatibility testing of medical products, clinical safety testing.
FDA Evaluation: Cosmetics, for example, evaluate packaging and composition.
I. Introduction to FDA
The Food and Drug Administration (FDA) is one of the implementing agencies set up by the U.S. government in the 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 foods, cosmetics, pharmaceuticals, biologics, medical devices and radiological products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function. FDA-approved foods, medicines, cosmetics and medical devices are safe and effective for the human body. In nearly one hundred countries such as the United States, only FDA-approved materials, devices, and technologies can be used for commercial clinical applications.
Two .FDA certification classification
We often say that the FDA certification, usually contains the following categories:
1. Food contact materials FDA testing
2. Laser product FDA registration
3. Medical Devices FDA registration
4. Cosmetics and daily necessities FDA test report
5. Food, Drugs, Cosmetics and Daily Use FDA Registration
Three .FDA certified certificate samples
Four .FDA certification FAQ
Question 1: FDA certificate issued by which agency?
A: The FDA registration is without a certificate, the product will register with the FDA, and the registration number will be obtained. The FDA will give the applicant a reply (signed by the FDA administrator), but no FDA certificate exists.
Question two: FDA need to specify the certification laboratory testing it?
A: The FDA is a law enforcement agency, not a service agency. If anyone says they are accredited laboratories under the FDA, then at least they mislead the consumer because the FDA has neither a public service certification body nor a laboratory nor a so-called "designated lab." The FDA, as the federal law enforcement agency, can not do such a thing as a judge or an athlete. The FDA will only certify the GMP quality of service testing labs and will issue a certificate of eligibility but will not "designate" to the public or recommend a particular family or agencies.
Question three: FDA registration must necessarily require an American agent?
A: Yes, Chinese applicants must nominate a U.S. citizen (company / community) as their agent for FDA registration. The agent is responsible for the process services in the United States and is the medium through which the FDA and the applicant can be contacted.
V. Why companies must pay attention to the FDA export certification of the United States
"Auto detainment" is a major measure administered by the U.S. Food and Drug Administration (FDA) on imported foodstuffs. In short, the goods that the FDA has declared as "automatic detainment" must arrive in the United States After passing the laboratory test, Fang will allow the release into the United States for sale.
Due to the small number of FDA personnel, it is impossible to carry out lot-by-lot inspection in the face of large quantities and large quantities of imported food products, medicines and cosmetics. Only 3-5% of the samples can be spot-checked. The spot-check sample If the sample is unqualified, the batch of products will be "detained" and disposed of. If the problems found in the inspection are general problems (such as trademark unqualified, etc.), the importer may be allowed to If the problems found in the inspection are related to the quality of hygiene, they are not allowed to be released or destroyed locally or transported back to the exporting country (region) by the importer and shall not be transhipped To other countries (regions) .In addition to spot checks there is a measure that the potential problems of imported products, customs clearance must be carried out when the inspection, rather than spot checks, which is the "automatic detention" measures, the FDA announced the right of a Product to take
The "automatic detention" can be based on the following reasons:
1. At least one sample found to be significantly harmful to human health, such as harmful elements, excessive pesticide residues, the presence of toxins, pathogenic microorganisms, chemical contamination, etc., violate the relevant provisions of low-acid canned food, or contain Declared the approved ingredients such as pigments.
2. If there is information or historical records, or received notice of the relevant departments of other countries, indicating that a country or region of products may cause harm to human health, and the FDA to assess the above sources to confirm that such products in The United States may also cause the same harm, Tony | lFDA also announced the automatic detention of such products, measures.
3. A number of samples tested failed, but no obvious harm to human health, such as deterioration of smell, inclusions, labeling unqualified, according to the following circumstances were the manufacturer, exporter or country (region) to declare to take "Automatic detention" measures:
(l) If a manufacturer or exporter exports to the United States product, 6 months at least three batches of the FDA inspection found problems, to be "detained", handled, and unqualified samples more than 25% of the samples were seized, The FDA will take "automatic detention" of such products exported to the United States by the manufacturer or exporter;
(2) If a country or region exports to the United States, 6 months at least 12 batches of the FDA inspection found problems, be "detained"
VI. FDA certified to do the most professional company
Shenzhen Central Granville detection is the most comprehensive FDA certification laboratory, with the United States agents and branches, FDA can quickly offer any product registration, and in the country established a large FDA testing laboratories, a variety of food contact Materials can be tested. Every year a large number of exports to the United States because of FDA certification issues stuck in the Customs, and even the goods were destroyed, causing huge losses, so if you have any exports to the United States business, may wish to ring ring Viagra professional FDA certified engineers, to help you Clear the obstacles, FDA professional contact: 4008-258-120
Seven .FDA certification of several types of distinction
FDA certification is usually divided into traditional FDA registration, FDA testing and FDA evaluation
FDA Registration Meaning: In order to ensure that the manufacturer's products are exported to the United States in line with the local FDA requirements, companies are required to declare the guarantee process. In fact, most of the FDA registrations have not been tested by a third party, but the company itself guarantees.
FDA testing: FDA testing refers more to the safety of food contact materials testing, biocompatibility testing of medical products, clinical safety testing.
FDA Evaluation: Cosmetics, for example, evaluate packaging and composition.