Medical devices refer to the instruments, equipment, appliances, materials or other articles used alone or in combination with the human body, including the required software. The functions of medical devices used on human body surface and in vivo are not obtained by means of pharmacology, immunology or metabolism, but these means may participate in and play a certain auxiliary role;

Its use is intended to achieve the following intended purposes:

（1） Prevention, diagnosis, treatment, monitoring and mitigation of diseases;

（2） Diagnosis, treatment, monitoring, mitigation and compensation of injuries or disabilities;

（3） Research, replacement and regulation of anatomical or physiological processes;

（4） Pregnancy control.

The following is an introduction to the certification services required for the export of medical device products to the U.S. market:

What is FDA certification?

The English abbreviation of the foodanddrugadministration (FDA) is an international medical audit authority authorized by the U.S. Congress or the federal government, which is a high law enforcement agency specializing in food and drug management. FDA is a government health control monitoring agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals committed to protecting, promoting and improving national health. Food, drugs, cosmetics and medical devices certified by FDA are safe and effective for human body. In nearly 100 countries such as the United States, only the materials, devices and technologies approved by FDA can be commercially applied in clinical practice.

FDA approved category:

1. FDA registration of laser products;

2. FDA inspection of food contact materials;

3. FDA registration of cosmetics;

4. FDA registration of medical devices;

5. FDA registration of food and drugs;

According to different risk levels, FDA classifies medical devices into three categories (I, II and III), and category III has the highest risk level. FDA clearly defines the product classification and management requirements of each medical device. At present, there are more than 1700 kinds of FDA medical device product catalogs. If any medical device wants to enter the U.S. market, it must first clarify the classification and management requirements of the products applied for listing.

(1) Class I medical devices: low risk (regulatory control type: basic control) products must meet the general requirements, and most of them can be registered directly without submitting a product safety and Effectiveness Report;

The application cycle is about 7-10 working days; Data: FDA medical application form, basic product information, product instructions, and US dollar official fee payment;

(2) Class II of class II medical devices: medium risk (regulatory control type: basic control and special control) products must meet the functional standards;

Most of the products that need to submit fda510 (k) (PMN market pre release notice) to FDA before registration can be registered and legally marketed after approval; The application cycle is more than half a year; 510 (k) only the product is demonstrated in writing, and does not involve the on-site audit of the factory quality system FDA GMP qsr820 before approval;

(3) Class III of class III medical devices: the most stringent control of high risks (regulatory control type: basic control and pre marketing approval), which must be approved before listing;

Most of them need to apply for FDA PMA market pre launch approval before product registration and legal marketing; The application cycle is more than one year; Before approval, FDA will conduct on-site review of FDA GMP qsr820 quality system for the manufacturer, and the PMA application for the product can be approved only after passing the review.

FDA is famous for its rigorous approval of medical devices and is a typical representative of zero tolerance, which has won great reputation and trust worldwide. To some extent, the approval of medical devices by FDA means that the products have obtained the highest level of safety and effectiveness certification. The PMA audit must be supported by sufficient scientific evidence to ensure that its intended use is safe and effective, which is a further upgrade of the original FDA audit specifications. PMA is the most stringent medical device regulatory approval project of FDA.

The above is the introduction of the testing and certification services required for the export of medical devices to the United States. If you have relevant medical device products that need to be certified for export to the United States, you can contact the Shenzhen Zhongqi inspection agency to obtain detailed cost quotation, cycle and other information!