1, should have with the business scope to match the business premises and warehouse, and the area has specific requirements. Divided into two cases, if the operation of the implantation of interventional products, then the business area is not less than sixty square meters, the warehouse is not less than thirty square meters, if the business scope contains in vitro diagnostic reagents, the area of the business premises should be compatible with the scale of operation, and not less than one hundred square meters, then the area of the warehouse it is not less than sixty square meters, the low-temperature refrigeration shall not be less than twenty cubic meters, this kind of This is generally the case with a third-party cold storage more, self-built due to cost reasons is very little,
2, should have a nationally recognized, and business products related to the professional staff on duty.
3, should have and business products related to the possession of technical personnel with secondary education or above.
4, with the operation of medical devices and the appropriate quality management system.
5. With the operation of medical devices, adapted to the professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support.
Application for a license to operate Class III medical devices need to submit the following materials:
1, product risk analysis information;
2, product technical requirements;
3, product inspection reports;
4, clinical evaluation information;
5, product manuals and labeling samples;
6, with product Development, production-related quality management system documents;
7, to prove that the product safety, effective and other information required.
Medical device registrant, the filer shall fulfill the following obligations:
1, the establishment of quality management system compatible with the product and maintain effective operation;
2, the development of post-marketing research and risk management plan and ensure the effective implementation;
3, according to the law, to carry out the monitoring of adverse events and reevaluation;
4, the establishment and implementation of the product Traceability and recall system;
5, the State Council drug supervision and management department of other obligations.
The country has a strict classification of medical devices, and Class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, refers to the implantation of the human body, used to support, maintain life, its safety, effectiveness must be strictly controlled medical devices.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 30 Engaged in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment, and professional and technical personnel;
(b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
(c) to ensure that the quality of medical devices management system;
(d) with the production of medical devices compatible with the after-sales service capabilities;
(e) in line with the requirements of product development, production process documentation.