The disposable sterile protective cover belongs to several types of medical devices. How to register?
According to the Regulations on the Supervision and Administration of Medical Devices, medical devices are divided into three categories according to the degree of risk:
Class I medical devices
Class II medical devices
Class III medical devices
How many types of medical devices do disposable sterile protective covers belong to?
According to the Classification Catalogue of Medical Devices, disposable sterile protective covers belong to Class II medical devices.
How to register disposable sterile protective cover?
1. Registration system: disposable sterile protective cover belongs to Class II medical devices, which can be marketed only after going through approval procedures such as medical device registration certificate.
Requirements for Class II medical device registration
1. The enterprise has obtained industrial and commercial registration in accordance with relevant regulations;
2. The declared products have been determined to be Class II medical devices;
3. The technical requirements for the medical device products to be applied for have been prepared and passed the pre evaluation.