Green Circle Speaks Cross-Border]-Article: How to Classify Medical Devices and Successfully Apply for FDA Registration

Medical device exporters to the United States must comply with the mandatory requirement of FDA registration. Otherwise, the goods will be detained and will not be able to clear customs smoothly. Below are the detailed requirements and procedures for FDA registration:

I. FDA medical device certification requirements:
The U.S. Food and Drug Administration (FDA) Modernization Act requires that all companies engaged in the manufacture, compounding, distribution, synthesis, assembly, processing, or importation or exportation of medical devices must register and list their products with the FDA. In addition, non-U.S. companies must submit to the FDA the name, address, and telephone number of a U.S. agent who will communicate with the FDA. It must also designate a U.S. agent who is responsible for emergency and routine communications. A U.S. Agent is an individual or organization in the U.S. or with a place of business in the U.S. that a foreign manufacturer designates as a registered agent for the purpose of FDA registration.

Classification of medical devices by FDA:
Currently, FDA registration of medical devices is divided into three categories:
(1) Class I medical devices: products with the lowest risk level, most of which can be registered directly, e.g. eyeglasses, swabs, etc;
(2) Class II medical devices: products with higher risk levels, most Class II products and a small number of Class I high-risk products are required to obtain a pre-market notification 510(K) first, and get the 510k number before registration and filing, e.g., contact lenses, medical masks;
(3) Class III medical devices: Products with the highest risk level require pre-market approval (PMA - Pre-Market Approval), e.g., artificial heart, cochlear implants, etc. The higher the risk level, the more difficult it is to obtain approval. The higher the risk level, the more difficult it is to obtain approval.

Medical device FDA registration process:
Medical devices vary according to their different classifications, risk levels and specific conditions:
Medical device FDA clearance requires manufacturers to follow stringent regulatory requirements to ensure the quality, safety and efficacy of their products. First.

1. It is necessary to judge the [medical device classification] to determine which category your medical device belongs to, as the FDA has different regulatory requirements for different types of medical devices.
2. Completion of subsequent applications based on medical device classification, e.g., pre-market notification application
   510(k), Premarket Approval (PMA), and other testing/approvals.
3. Apply for DUNS Dunn & Bradstreet code;
4. Fill out the application form, provide product-related information, and complete the product listing;
5. Submission of data for FDA review;
6. FDA approved and received FDA registration number.

*After the registration is completed, the FDA will conduct post-marketing surveillance and monitoring of the medical device, including review and approval, quality management system, adverse event reporting, and periodic audits and inspections.

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