Medical devices need to obtain a business license, with quality management personnel, with business premises, with business storage conditions, with the relevant business management system, with professional guidance, technical training.
1, the operation of medical devices need to obtain a business license, the scope of business must contain medical equipment sales.
2, 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 professional qualifications or titles.
3, with the business scope and scale of operation of the business, storage space.
4, with the business scope and scale of operation of the storage conditions, all entrusted to other medical equipment business enterprises can not set up storage.
5, with the operation of medical devices and quality management system.
6, with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations.
Legal basis:
Medical device registration is introduced in Article 3 of the "Code for Quality Management of Medical Devices" medical device registration means that the applicant for registration of medical devices (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements for medical device registration application, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, The drug regulatory authorities based on scientific knowledge, safety, effectiveness and quality control and other reviews, to decide whether to agree with the activities and management of its application.
Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management departments to submit the record information, drug supervision and management departments of the filing of information submitted to the record of the activities.
The above content refers to Baidu Encyclopedia - Medical Device Business Quality Management Standard