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 III medical devices shall apply for a permission from the municipal drug regulatory department divided into districts where it is located and obtain a business license.
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.
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.Basic information and function description of the computer information management system.
6.Operating equipment list
Notes: 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 whole set of documents required for license application(except QMS preparation and on-site service).
2.Assist in building the quality management system and pre-review the quality management system on site.
3.Full services from site planning to the construction of QMS and license application.
D. Required Period
Expected period to obtain license for Class III : 1-3 months.
E. Service Flow Chart