1, with an office area of not less than 40m2; (business building or facade shop);

2. The warehouse area shall not be less than15m2; (Our company can provide it) (Three kinds of in vitro diagnostic reagents need to be frozen);

3. If there are three types of disposable goods, the total office address and warehouse area should not be less than160m2;

If the warehousing is entrusted to a third-party logistics company, a logistics company with medical device licensing qualification is needed.

There are requirements for personnel who record the operation of Class II medical devices:

1. Personnel with technical titles of medical devices, medicine and pharmacy 1 person, responsible for quality.

2.2 people with high school education or above, as a quality administrator;

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Application materials required for medical device business record certificate:

1. Operation Record of Class II Medical Devices

2. Copy of business license and organization code certificate

3 copies of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality.

4. Description of organization and department settings

5. Description of business scope and mode of operation;

6. A copy of the geographical location map, floor plan, house title certificate or house lease certificate of the business premises and warehouse address;

7. Catalogue of operating facilities and equipment;

8. Manage the quality management system and work