Currently, the epidemic in China has been effectively controlled, but the virus has spread globally. The number of infections in European and American countries such as Japan, South Korea, and Italy continues to increase. In the next month, the global demand for masks will be expanded.
If masks imported from the United States are to be sold, they must obtain FDA certification before they can be sold in the US domestic market.
Q: What is FDA?
A: The US Food and Drug Administration (Food and Drug Administration) is referred to as FDA. According to regulations, all food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages and electronic products with an alcohol content of less than 7% that are produced in the United States or imported and sold in the United States must pass FDA inspection It can be sold on the market only after it is proven safe.
When these products arrive at the U.S. port, random inspections will be carried out on a batch-by-batch basis. The batch of products will only be released if the samples are qualified. If they are not qualified, the FDA has the right to inspect the manufacturers and prosecute the offenders. “Automatic detention” is also possible.
To put it simply, the US FDA registration is equivalent to China’s product filing. All ordinary consumer products exported to the US need to be FDA registered. This is to make your products legal in the US.
Q: FDA registration and testing, silly and unclear?
A: Strictly speaking, there is no name for FDA certification, this FDA itself has said. Generally speaking, FDA certification mainly refers to the following three types: FDA registration, FDA testing and FDA approval.
FDA registration: For companies that export food, drugs and medical devices to the United States, they must register with the FDA for company listing and product listing, otherwise the customs will not clear customs. This is a mandatory requirement.
FDA testing: FDA testing refers more to the safety testing of food contact materials, product contact packaging testing, biocompatibility testing of medical products, clinical safety testing, etc.
FDA Approval: This type of drug is generally targeted at more drugs, that is, this drug is allowed to be marketed;
Q: How to apply for the FDA certification of medical protective masks?
A: Medical devices exported to the United States must be FDA registered. There are two registration methods for medical masks in the United States. One is a Class I medical mask, which is a 510(K) exempt product. It only needs to be registered and product listing. The other is the common surgical mask (Surgical). Mask), this kind of mask is a non-510(K) exempt product in the FDA. Not only must the factory registration and product listing be carried out, but also 510(K) documents must be prepared and submitted to the FDA for review. Only after the review can it enter the US market.