Hello! If it is only for personal use the beauty instrument is not need to apply for FDA registration. However, if the product is exported to the United States, it is required to be registered with the FDA according to local regulations.
An FDA medical device registration/certification
The U.S. Food and Drug Administration (FDA) requires that all firms engaged in the production, formulation, dissemination, synthesis, assembly, processing, or import/export of medical devices:
(1) be registered with the FDA. >register with the FDA;
(2) product listing;
(3) In addition, non-U.S. companies must designate a U.S. agent to communicate with the FDA on their behalf.
Second, medical device classification
Currently, the FDA is divided into three categories for the registration of medical devices:
(1) a class of medical devices
These are the products with the lowest risk level, and most of them can be registered and listed directly, for example: Eyeglasses, swabs, etc.
(2) Class II medical devices
Higher risk products, most Class II products and a small number of Class I high-risk products need to obtain a pre-market notification 510(k), to get the 510(k) number to be able to carry out the registration of the listing, such as
(3) Class III medical devices
The products with the highest risk level need to do Pre-Market Approval (PMA: Pre-Market Approval), e.g., artificial heart, cochlear implant, etc. The higher the risk level, the more important it is to get approval. The higher the risk level, the more difficult it is to obtain approval.
Three, FDA registration process
1. Need to determine the medical device classification to which the mask belongs to your company, to determine your company's medical device belongs to a class, the U.S. FDA on different types of medical devices have different regulatory requirements;
2. Classification of medical devices, to complete the subsequent application work, such as: application for pre-market notification 510 (k), pre-market application for PMA (Premarket Approval) and other testing/approval content;
3. Application for DUNS Dunn & Bradstreet DUNS code;
4. Fill out the application form, provide product-related information, and complete the product listing;
5. Submit the information to the FDA for review;
6. FDA review and approval, and obtain the FDA registration number.
*After the registration is completed, the FDA will carry out market supervision and regulation of medical devices after they are marketed, including review and approval, quality management system, adverse event reporting, periodic audits and inspections.
To learn more about FDA medical device registration/certification, you can contact us at #Registrar Corp
.