How medical devices are classified according to abcd four classes

a, b, c, d, e, f classification standards, is to apply for a medical device license or production license site and personnel acceptance criteria.

It is recommended that you go to the official website of the local Food and Drug Administration, check the acceptance criteria in the application for a medical device license matters document, which has a specific introduction.

Specifically as follows:

Class A (disposable sterile and medical consumables): 6815, 6863, Class II 6864, 6865 (except Class B), 6866.

Class B (implantable, interventional and other high-risk products): Class III 6804, 6821-1, 6821-2, Class III 6821-3, Class III 6822 (except Class E), 6845, Class III 6822 (except Class E). Class III 6804, 6821-1, 6821-2, Class III 6821-3, Class III 6822 (except Class E), 6845, Class III 6846, Class III 6864, 6865-3, and 6877.

Class C (general medical equipment): 6821 (except Class B), Class II 6822, 6826, 6840, 6841, 6854, 6855, 6856, 6857, and 6858.

Class D (large-scale medical equipment): 6823, 6824, 6824, 6824, 6857, 6858. ): 6823, 6824, 6825, 6828, 6830, 6831, 6832, 6833, 6870.

Category E (dispensing category): corneal contact lenses (soft, rigid and plastic corneal contact lenses) and their care fluids.

Class F (general medical devices): In addition to Class A-E, other Class II medical devices in the "Classification of Medical Devices" (2002 edition) need to apply for a "Medical Device Operator's License" to operate.