The export has become an important business activity. However, to enter the markets of different countries, it is necessary to follow their respective regulations and standards. This article will analyze in detailMedical EquipmentWhat certifications are required for medical devices, as well as the US management system for medical devices.for containers exported to the USI. Legislation and Competent Authorities of Medical Devices in the United States

The definition of medical devices by the US FDA includes instruments, equipment, appliances, devices, implants, in - vitro reagents or other similar or related items intended for the diagnosis of diseases or other conditions in humans or animals, or for the monitoring, alleviation, treatment or prevention of diseases. The United States classifies medical devices into three categories: Class I is a general control product, Class II requires special controls to ensure its safety and effectiveness, and Class III products need to go through the Pre - market Approval (PMA) procedure before they can be approved to enter the market.Cosmetics & Personal CareThe ways for medical devices to enter the US market are: exemption; 510(k); PMA. 510(k) is the Pre - market Notification, which proves that the product is substantially equivalent to a legally marketed product. PMA refers to Pre - market Approval, providing sufficient and effective evidence to prove that the medical device can ensure the safety and effectiveness of the product according to its designed and produced intended use.

The FDA promulgated the Good Manufacturing Practice for Medical Devices (GMP) in 1987 and announced a new GMP specification in 1997, which was renamed the Quality System Regulation for Medical Devices (QSR). This specification requires all medical device manufacturers to establish and maintain a complete and effective quality management system.

The United States implements a mandatory post - marketing monitoring system for medical devices. The FDA mainly conducts post - marketing supervision by inspecting the quality systems of enterprises. The quality systems of Class II and Class III products are inspected every two years, and the quality system of Class I products is inspected every four years. If there are potential hazards or problems are found, the FDA can inspect the enterprise at any time.

Article 520(g) of the US Federal Food, Drug, and Cosmetic Act and the Medical Device Safety Act both have the Investigational Device Exemption (IDE) clause, which puts forward requirements for clinical research on medical devices. IDE is to promote the invention and development of new medical devices, and it covers the regulations for conducting clinical research on medical devices.

South Korea: Revise the International Standards for Medical Device Exports

美國食品、藥品和化妝品法520(g)條和醫(yī)療器械安全法都有”研究器械豁免（Investigational Device Exemption，IDE）”法條，對醫(yī)療器械臨床研究提出了要求。IDE是為了促進發(fā)明和發(fā)展新的醫(yī)療器械，它涵蓋了進行醫(yī)療器械臨床研究的規(guī)定。