1, with the business scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant academic qualifications or titles;
2, with the business scope and scale of operation of the business, storage place;
3, with the business scope and scale of operation of the storage conditions, all Commissioned other medical device business enterprise storage can not set up a warehouse;
4, with the operation of medical devices appropriate quality management system;
5, with the operation of medical devices appropriate guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations.
The process of applying for a medical device license is as follows:
1, the operator of the business enterprise license application form for medical devices, qualification certificates, business license or business name pre-approval of a copy of the supporting documents to the municipal people's government in the location of the application for a license to operate;
2, the staff accept the information. And within 30 working days for review, if necessary, the organization verification;
3, in line with the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, do not permit and give reasons in writing.
In summary, do medical devices need to apply for relevant documents, sales of medical devices need to apply for sales-related qualifications.
Legal basis:
"Supervision and Administration of Medical Devices Regulations" Article 31
Engaged in the production of Class I medical devices shall be located in the municipal people's government responsible for the supervision and management of pharmaceuticals for the record, in the submission of the relevant information in line with the conditions set out in Article 30 of the Regulations that is completed for the record.
Medical device recorders to produce their own Class I medical devices, in accordance with the provisions of Article XV of the Regulations for the product record and submit the conditions in accordance with the provisions of Article 30 of the Regulations, that is, to complete the production of the record.