Distributor Licensing for Class Ⅱ MD

A. Legal Accordance

As required by Regulations for the Supervision and Administration of Medical Devices and Measures for the Supervision and Management of Medical Device Operation,an enterprise engaged in the operation of Class II medical devices shall apply for a permission from the municipal drug regulatory department divided into districts where it is located and obtain a credential for the business operator.

 

Those who engage in the business of medical device without filing will be confiscated of illegal income, medical devices that are illegally operated, and tools, equipment, raw materials and other items used in illegal production and operation,if the value of the medical devices illegally operated is less than 10,000 yuan, a fine of 50,000 yuan up to 100,000 yuan shall be imposed,if the value of the goods is over 10,000 yuan, a fine of not less than 10 times but not more than 20 times the value of the goods shall be imposed,If the circumstances are serious, the application for medical device license from relevant responsible persons and enterprises shall not be accepted within 5 years.

 

B. Documents provided by client

1. Copy of business license.

2.Copies of certificates of identity, educational background and professional title of legal representative, person in charge of the enterprise and quality person in charge.

3.Organization chart.

4.Geographical position and floor plans of the business premises and warehouses,documents proving the property rights of the premises or the lease agreement(with documents proving the property rights).

5.Operating equipment list

 

Note: for municipal administrative business ,requirements vary from place to place. For details, please refer to regional-level requirements.

 

C.  Professional Services from ZOOP

1. Compile the documents required for filing, submit it to the NMPA and in charge of the whole process until the license is obtained.

2. Guidance of QMS construction and system pre-examination and on-site pre-review.

 

D. Required Period

Expected period to obtain license for Class II :1-1.5 months

 

E. Service Flow Chart