Detailed process for Shenzhen to handle FDA testing

Different medical devices have different risk levels. According to the risk levels, the FDA can divide medical devices into three categories (I, II, and III). The larger the number, the higher the risk level. There are more than 1,700 types of FDA's medical device product catalog, and each medical device has clearly defined product classification and management requirements. All medical devices that want to be sold on the US market must first clarify the classification and management requirements of the products applying for listing.

The classification is not clear, this is the medical device of many enterprisesFDA certificationThe problems that can occur in the process are not clear between Type I and Type II. In addition to the unclear classification of categories, some customers do not understand the FDA control regulations. Many people think that after FDA certification, they will be fine, and they can clear customs without suspense, and don't care about product quality. Here we need to remind corporate customers that the US Customs often conducts temporary random inspections on products imported from China. If the quality of the exported products is poor, if the inspection fails, the FDA will penalize the exporter very severely, so this is also a need to pay attention to. Point.

Medical device processing FDA application cycle:

For products of different product categories, the application period is different.

For products under general control, except for GMP implementation, the period of company registration (Registration) and product listing (Listing) is about one week.

For PMA and PMN products, it is generally more than half a year.

FDA certification process for medical devices:

1. Consultation---The applicant provides product information pictures or describes the products and materials needed to apply for FDA

2. Quotation---Based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items to be tested, and quote the applicant

3. After the applicant confirms the quotation, fill in the test application form and test samples

4. Sample test-the test will be conducted in accordance with the applicable FDA test standards

5. Provide FDA test certification report after the test is completed

Shenzhen Liban Testing Technology Service Co., Ltd. is a comprehensive third-party organization integrating testing, inspection, certification and technical services. If you want to apply for FDA certification or want to know more information, please feel free to contact us!