Medical Device Operation Permit Application in China

There are three classes of medical devices. For Class I, the company should have related business scope; as for Class II, the company would need to apply for operation record; and for Class III, the company should apply for operation permit.

1. Get the company registered with business scope of “sales of Class II medical devices”.

2. At least one employee with a medical or pharmaceutical degree or above (resumes, copies of licenses, and proof of education).

3. A regular warehouse with an area of over 45㎡ and a total area of over 100㎡.

4. A copy of the property certificate and the original lease agreement (rented in the name of the company).

5. Supplier needs to provide: a copy of business license, product registration certificate, quality assurance certificate, authorization letter (stamped with official seal).

6. Business license with official seal, etc.

We need to check the registration certificate of Class III medical device products first, to provide more detailed information for your reference.

1. Get the company registered with business scope of “sales of Class III medical devices”.

2. Personnel: A total of 9 positions are set up in ordinary Class III medical devices operating enterprises, including legal representative, enterprise leader, quality manager, quality manager of institute management, inspector, sales, after-sales, warehouse management, and computer management. These positions can be held concurrently, but at least 3 personnel, with documents such as the original and the copy of identification certificates and academic certificates.  Meanwhile, the quality manager must have 3 years of management experience and medical related academic.

If the company would operate in vitro diagnostic reagent, implants and interventional medical devices, contact lens or other special medical devices, there are more requirements for the personnel. Please contact our professional consultants for more information.

2. Medical device management software (requires purchasement invoice).

3. A copy of the property certificate and the original lease agreement (rented in the name of the company).

4. Supplier needs to provide: original and duplicate copies of registration certificate and supplier related qualifications (business license, medical device registration certificate), stamped with official seal (provide manufacturer or general agent registration certificate).

5. Enterprise management system, after-sales service system, employee training system.

6. Business license with official seal, etc.

We are able to provide registration address for our clients who would like to engage in medical device operation business but have not rented office yet. With our almost 20 years industry experience and abundant resources, we will help you go through the process smoothly.