Drugdu.com expert's response:

To obtain a Class III Medical Device Operating License, you would need to follow a specific process and meet certain requirements. Here is a general outline of the steps in English:

1.Prepare Application Materials: Gather all necessary documents, including the "Application Form for Medical Device Operating License" (signed by the legal representative or stamped with the company seal), proof of identity, education, and appointment documents for the legal representative. Also, provide copies of the "Pre-Approval Notice for Enterprise Name" or "Business License" issued by the Administration for Industry and Commerce. Additionally, submit proof of property or lease agreements with the lessor's property certificate, as well as layout plans of the business premises and warehouse.

2.Submit Application Materials: Submit the prepared application materials to the local Food and Drug Administration or Market Regulatory Department.

3.Review and Onsite Inspection: The local Food and Drug Administration or Market Regulatory Department will review the submitted materials and may conduct an onsite inspection to ensure compliance with relevant regulations and standards.

4.Issuance of License: If the application is approved, the relevant department will issue the Class III Medical Device Operating License.

During the process, you must also ensure that you meet specific conditions, such as having business premises and warehouses that match the scope of your operations, with specific area requirements based on regulations. Additionally, you need to have on-staff personnel with relevant professional backgrounds recognized by the state, as well as technical personnel with secondary education or above related to the products you operate. You must also possess a quality management system that is compatible with the medical devices you operate and can be effectively implemented. Furthermore, you must have the ability to provide professional guidance, technical training, and after-sales service related to the medical devices you operate.

Please note that the specific procedures and requirements may vary depending on the region and specific circumstances. Therefore, it is recommended to consult the local Food and Drug Administration or Market Regulatory Department for accurate information before applying.