1, with the scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have the relevant professional qualifications or titles.
2, with the business scope and scale of operation of the business premises.
3, with the business scope and scale of operation of the storage conditions.
4, with the operation of medical devices and quality management system.
5, with the operation of medical devices appropriate professional guidance, technical training and after-sales service quality management organization or personnel.
Class II medical device refers to those medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
1, in order to ensure that the circulation and use of such medical devices comply with the relevant regulations and standards, it is necessary to carry out strict management and supervision of their business behavior.
2, therefore, enterprises or individuals dealing with Class II medical devices need to be filed and meet certain conditions.
These conditions may include, but are not limited to:
1, with the appropriate qualifications and qualifications, such as medical device business license or filing credentials, etc.;
2, with the appropriate quality management institutions or personnel to ensure the quality and safety of the medical devices;
3, with the appropriate storage conditions, such as warehouses, facilities, etc., in order to ensure that the medical devices are Proper storage;
4, with appropriate professional guidance, technical training and after-sales service quality management organization or personnel, to ensure the proper use and maintenance of medical devices.
In summary, enterprises or individuals operating Class II medical devices need to meet certain conditions and file. These conditions include having the appropriate qualifications and qualifications, quality management organizations or personnel, storage conditions, as well as professional guidance, technical training and after-sales service. Only by meeting these conditions and complying with relevant regulations and standards can the safe and effective circulation and use of Class II medical devices be ensured.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Chapter IV
Article 30
Provides that engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal government of the food and drug supervision and management department for the record and to submit its compliance with the conditions set out in Article 29 of the Regulations of the proof of information.