Bringing Class I Medical Devices to Market
Class I devices are the fastest and easiest to bring to market since they present the lowest amount of risk to the patient and are rarely critical to life-sustaining care. The majority of Class I devices are exempt from FDA requirements for Premarket Notification (510k) and Premarket Approval (PMA).
Class I devices are not exempt from FDA general controls, a series of commands which applies to Class I, II, and III medical devices. The provisions of this act address adulteration, misbranding, device registration, records, and good manufacturing practices. Medical device manufacturers who fall into Class A are still required to implement a quality management system and follow standards to ensure a quality product.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
