1. What is FDA registration?

 

FDA registration, can also be called FDA registration. Refers to cosmetics, medical equipment, food, laser, LED lamps and other products exported to the United States must be registered with the US Federal Food and Drug Administration, and to ensure that products meet the relevant US standards and health and safety requirements, some of which must also be issued Related tests can be successfully registered. For example, clinical categorical and tertiary medical products must provide 510K documents to register with the FDA.

 

 

Second, the common misunderstanding of FDA registration

 

1. FDA registration is different from CE certification. The mode of certification is different from the product certification + report certificate mode of CE certification. The FDA registration actually adopts the integrity declaration mode, that is, you are responsible for compliance with relevant standards and safety requirements. And register on the US federal website, if the product has an accident, then it must bear the corresponding responsibility. Therefore, FDA registration does not exist for the detection of samples and certificates for most products. Therefore, the online transmission is full of enthusiasm, wow haha obtained FDA certification and Quan Jian products obtained FDA certification, to show the safety of their products, is a misunderstanding, there is no FDA, it is a very high-end situation.

 

2. FDA registration validity period: FDA registration is valid for one year. If it is more than one year, it needs to be re-submitted for registration. The annual fee involved also needs to be re-paid.

 

3. Does the FDA have a certificate? : FDA registration In fact, all actions are registered online, there is no certificate. So what is the FDA certificate circulating in the market? In fact, they are all a self-declaration document issued by the agency to prove that the product has been registered as an FDA. Such as:

 

 

 

 

3. What is the difference between FDA registration, FDA testing, and FDA certification?

 

Can be understood like this,

 

FDA testing is generally for these types of products:

 

1. Two or three types of medical devices;

 

2. Cosmetics, daily necessities;

 

3. Food contact materials;

 

FDA registration is generally divided into:

 

Cosmetics

 

2. LED and laser products

 

3. Medical equipment

 

4. Food

 

5. Drugs

 

FDA certification is the collective name for FDA testing and FDA registration. Both can be called FDA certification. FDA certification is just a common language.

 

 

Fourth, the latest trend of FDA registration

 

 Recently, LED lights will be covered by the FDA. It is understood that after the implementation of this rule, LED light products will face a double "level check" review, in addition to customs clearance, customs clearance may also require FDA release. However, this change only involves the LED lamp itself, and does not involve the use of LED lights (such as lamps without the LED lamp itself).

According to industry insiders, LED lights are included in the FDA's regulatory scope, and the requirements for the export logistics industry will be more stringent. They need to be clear about the manufacturers and refuse to accept irregular products when receiving customer goods. At the same time, when providing customs clearance materials, it is necessary to provide the manufacturer information of the LED lamps together, including the manufacturer's name, address and contact number, so as to avoid delays in customs clearance.

It is reported that if you only use LED lights but do not have LED lights, you need to clearly mark them in the customs clearance materials.