Guangdong Province to start medical equipment business license acceptance criteria when abolished

Hello, this is not issued to determine the need for the relevant departments to introduce new provisions of the old will be repealed, is still in effect in 2012 issued by the "Guangdong Province to start the implementation of standards for the acceptance of medical equipment business enterprises". If you want to apply for the relevant qualifications, please follow the above provisions in detail to operate on it.

Appendix:

A. The standard paragraphs 1 to 20 for the general requirements, "classification management" in the paragraphs for the special requirements. Inspection and acceptance, the general and specialized requirements of the applicable provisions of all must comply. There is more than one does not meet the requirements of the acceptance is judged to be unqualified.

II. Classification of management categories in accordance with the "Classification of Medical Devices Catalog" (2002 edition):

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

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

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

Category D (large medical equipment category): 6823, 6824, 6825, 6828, 6830, 6831, 6832, 6833, 6870.

Category E (fitting category): corneal contact lenses (soft, rigid, 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 Catalogue of Medical Devices (2002 edition) that require application for a Medical Device Operator's License.

Three, the standard implementation terms "on the high not low" principle, for example:

At the same time operating A, B class, the warehouse shall be 200 square meters, the personnel shall be B class requirements.

At the same time the operation of C, D and not entrusted to the distribution, the warehouse needs 40 square meters.

At the same time all categories of business, the warehouse shall be 200 square meters, personnel, equipment and systems shall be B + E requirements.

And so on.

In vitro diagnostic reagent category warehouse shall not be with the ordinary two or three categories of warehouse **** there.

Four, this standard and the appendix said "above", including this number.