FDA certification profile
The U.S. Food and Drug Administration (Food and Drug Administration) referred to as FDA, FDA is the United States government in the Ministry of health and human services (DHHS) and the Ministry of public health (PHS) set up one of the executive bodies. As a scientific management body, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radioactive products produced or imported in the United states. It was one of the first federal agencies to protect consumers. The institution is closely related to the lives of every American citizen. Internationally, FDA is recognized as one of the largest food and Drug Administration in the world. Many other countries promote and monitor the safety of their products by seeking and receiving help from the FDA.
FDA certification mark
FDA product certification range
1. food products;
2. medical device products;
3. cosmetics;
4. radiation and laser electronics (NTEK);
5. nutrition and health care products;
6. Chinese herbal medicine and patent medicine;
7. care and health care equipment;
8. canned food;
FDA certification for radiation and laser products
Our laser radiation, do electronic product certification, and the release of radiation of electronic products, including TV screen, antenna and microwave, diagnostic equipment and X light X light or laser products, such as CD-ROM and laser designator (1aser poin1cr)). Most releases of radiation electronic products are not considered as medical devices, unless the manufacturer or dealer claims that the product has medical function, the product must comply with the FDA specification for medical equipment. The main reason why the United States will regulate the release of radiation electronics is to prevent the health effects of consumers from using such products. Therefore, when applying for EDA certification, you need to provide information:
1. self conformity declaration form;
2. product registration;
3. test standard;
4.Product Repor1s;
5.Anllual Reports;
The annual report should each September 1st by mail to FDA, if not regularly updated product will be detained by customs clearance. If the owner fails to send the report promptly due to negligence and the product is detained, the customs may accept the relevant information from the supplier and then pass it through to the customs.
6. test records;
7. relevant records;
8. warning signs.
FDA certification data preparation
(a) the name of the product: the full name of the product;
(b) product model: detailed list of all products, models, varieties, or classification numbers that need to be tested;
(c) the intended use of the product: for example: home, office, factory, coal mine, ship, etc.;
(d): detailed parts list parts and types of products (Wu composition classification), the name of rating, manufacturer, for insulation materials, please provide raw materials.
(E) electrical performance: for electrical and electronic products, an electrical schematic (wiring diagram) and an electrical performance meter are provided;
(f) structure diagram: for most products, a product structure or explosion diagram, a burden list, etc. should be provided;
(g) photographs, instructions for use, safety, or installation instructions of the product. If the sample is not allowed to be broken, it is necessary to provide a laser head picture.
FDA certification process
1. submit application forms, samples and related materials;
2. test, issue report;
3. submit to FDA audit;
4. through the audit number, issuing.
FDA certification factory inspection
No factory inspection required.
FDA authentication cycle
The routine is 3-4 weeks. It can be expedited or expedited.
Tianjin FDA certification authority
As the FDA certification authority, ring detection is not only has a professional independent laboratories and a group of FDA certified engineers with rich experience, can provide customers with all-round and one-stop testing and certification services, and reached agreement with the United States, Britain, Germany and other 58 countries and regions, detection the report has international credibility. If you have a product that requires FDA certification, please contact the Engineer at 022-84819220.