What is the difference between FDA certification and FDA registration, FDA certification and FDA registration for laser products?
Time:2020-03-04
Views:984
What is the difference between FDA certification and FDA registration for laser products? First of all, there is no formal FDA certification. There are generally the following three names.
1, FDA approval, this is generally for more drugs, is to allow the drug on the market;
2, FDA registration, this kind of previous terrorism before, is the product to the FDA official website registration, some products need to be tested;
3.FDA testing, which is conducted according to the regulations published by the FDA, is conducted to see whether the product meets the requirements of the FDA regulations. This kind of testing is done by a third party, and the FDA itself does not do any testing. They are mainly responsible for making regulations and market regulation. The above three domestic products generally like to call the FDA certification.
Often said FDA certification refers to the FDA registration number, FDA registration will have a registration number, need to be used when customs clearance, and FDA only recognize this registration number, FDA certificate is usually a third party organization for customers, not the official FDA issued a form.
The US Food and Drug Administration (Food and Drug Administration) is FDA. FDA is one of the executive agencies established by the US Government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory body, the FDA‘s responsibility is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products manufactured or imported locally in the United States. It is one of the federal agencies with an early primary function is consumer protection. Therefore, FDA registration includes many product categories, and different product registration needs to submit different materials and requirements, such as the information that needs to be prepared for laser products.
1. Application form
2. Instructions (in English)
3. Circuit diagram (in English)
4. Positive and negative diagram and wiring diagram of PCB
5. List of components and BOM table
the laser pathway diagram
6. Tags.
7. Testing flow chart of quality assurance, production safety, and the whole process from production to warehousing
8. Inform the laser composition
Deeplight standard has rich experience in laser product certification test, and can provide customers with IEC60825 test report, US FDA21CFR1040.10 test report, China GB7247 laser test report.
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