Yes.
According to the People's Republic of China *** and the State Council Decree No. 650 Regulations on the Supervision and Administration of Medical Devices (Violation of the provisions of this regulation constitutes a crime, shall be investigated for criminal responsibility according to law; caused personal, property or other damage, shall bear the responsibility for compensation according to law.)
Chapter III Medical Device Production ?
Article 32
Medical equipment business enterprises, the use of units to purchase medical devices, shall check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second, third class medical device wholesale business and the third class medical device retail business enterprises, should also establish a sales record system.
Record matters include:
1, the name, model, specifications, quantity of medical devices;
2, the production batch number of medical devices, the expiration date, the date of sale;
3, the name of the manufacturer;
4, the name of the supplier or the purchaser, address and contact information;
5, the relevant license Proof of document number, etc.
6, purchase inspection records and sales records should be true, and in accordance with the State Council food and drug supervision and management department of the period to be preserved. The state encourages the use of advanced technical means to record.
Article 33
Transportation and storage of medical devices shall comply with the requirements of medical device instructions and labeling; temperature, humidity and other environmental conditions have special requirements, shall take appropriate measures to ensure the safety and effectiveness of medical devices.
Article 34
Medical devices should be used with the medical equipment, the number of varieties of storage space and conditions appropriate to the use of medical devices.
Medical equipment use units should strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices.
Article 35
Medical device use units for reuse of medical devices, shall be in accordance with the provisions of the State Council department in charge of health planning and management of sterilization.
Disposable medical devices shall not be reused, the used shall be destroyed and recorded in accordance with relevant state regulations.
Article 36
Medical device use units need regular inspection, testing, calibration, maintenance, maintenance of medical devices, shall be in accordance with the requirements of the product specification for inspection, testing, calibration, maintenance, maintenance and record, timely analysis, evaluation, to ensure that the medical device is in good condition, to ensure the use of quality.
The use of large medical devices for a long period of time, should be used to establish a file, record its use, maintenance, transfer, actual use of time and other matters. Record-keeping period shall not be less than five years after the termination of the specified period of use of medical devices.
Extended information:
On the production of medical devices (Medical Device Supervision and Administration Regulations)
Article 22
Engaged in the production of Class II and Class III medical devices, the manufacturer shall apply to the food and drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government for production authorization and submit its compliance with the conditions of the provisions of Article 20 of the Ordinance to prove the information as well as the production of medical devices registration certificate.
Acceptance of applications for production authorization of food and drug supervision and management department shall accept the application within 30 working days from the date of application for review, in accordance with the State Council food and drug supervision and management departments to develop the requirements of the quality management standard for the production of medical devices for verification.
To meet the prescribed conditions, permission is granted and issued to the production of medical devices license; do not meet the prescribed conditions, not licensed and the reasons in writing. Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.
Article 23
Medical device production quality management standards should be on the design and development of medical devices, production equipment conditions, raw material procurement, production process control, enterprise organization and staffing and other matters affecting the safety and effectiveness of medical devices to make clear provisions.
Article 24
Medical device manufacturers shall, in accordance with the requirements of the quality management standard for the production of medical devices, establish and improve the production of medical devices and ensure the effective operation of the quality management system; strictly in accordance with the registered or filed by the technical requirements of the product to organize the production to ensure that the medical device meets the mandatory standards as well as registered or filed by the technical requirements of the product. Technical requirements.
Medical device manufacturers should regularly on the operation of the quality management system for self-examination, and to the seat of the provincial, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department to submit a self-examination report.
Chinese People's **** and the official website of the central government of the state - medical equipment supervision and management regulations (State Council Decree No. 650)