Home » Medical Equipment » What certifications are required for medical devices exported to the United States?
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
II. Definition and Management Classification 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.
III. Market Access of Medical Device Products in the United States
The FDA defines medical devices as instruments, apparatuses, implements, machines, implants, in vitro reagents or other similar articles intended for diagnosing disease/conditions in humans/animals or for disease monitoring, alleviation, treatment or prevention. The US classifies medical devices into three categories: Class I as general control products, Class II requiring special controls to ensure safety/effectiveness, and Class III products requiring Premarket Approval (PMA) before market entry.
IV. Quality System of Medical Devices in the United States
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.
V. Post - marketing Management of Medical Devices in the United States
In 1987, FDA issued Good Manufacturing Practice (GMP) for medical devices, and in 1997 published new GMP regulations renamed Quality System Regulation (QSR). This requires all medical device manufacturers to establish and maintain a complete quality management system.
VI. Clinical Trial Application
South Korea: Revise the International Standards for Medical Device Exports
The management of medical devices in the United States began with the Food, Drug, and Act in 1938. In 1976, the US Congress passed the amendment to the Federal Food, Drug, and Cosmetic Act, strengthening the supervision and management of medical devices and establishing a classification management method for medical devices. In 1990, the US Congress passed and the President signed the Medical Device Safety Act. The US Food and Drug Administration (FDA) is responsible for the comprehensive supervision and management of products such as drugs, foods, cosmetics, medical devices, and veterinary drugs.
Both Section 520(g) of the FD&C Act and the Medical Device Safety Act contain Investigational Device Exemption (IDE) provisions for medical device clinical studies. IDE aims to promote invention/development of new devices, covering regulations for conducting clinical research.
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