Medical network - on April 10, recently, the liaoning province food and drug administration issued "the provincial medical planted instruments use operation link violation behavior rectification work plan, decided to throughout the province to carry out the rectification of action for six months. 

 

This regulation aims to resolutely correct parts business unit using the possible existence of acceptance and use of medical planted instruments record is not complete, cannot achieve the traceability, etc, to crack down on unlicensed operation and management, products of use without registration and beyond management violation behavior. 

 

, according to the plan, the regulation mainly in business processes and the use of two aspects. 

 

In business, focusing on the following nine aspects 

 

1. Whether the products obtained the registration certificate of medical equipment, qualified certificate whether is complete; 

 

2. Medical equipment management (production) permit (production) scope is covering the product; 

 

3. Whether to set up and appropriate to the scope of business and business scale of quality management organization or the quality manager; 

 

4. If equipped with medical, college degree or above in related majors, and trained personnel; 

 

5. Computer information management can guarantee the product traceability; 

 

6. Whether to establish a review for ins and outs of stock checking and accepting, and sales and the return of the goods or the nonconforming product management system; 

 

7. For ins and outs of receiving inspection records, check records, sales records and return record is true and accurate, and conforms to the traceability requirements; 

 

For 8. For clinical selection of unused returned to the management of the medical devices, can ensure the quality and safety, and is consistent with the enterprise management system; 

 

9. Do you have a manual in Chinese imports, the Chinese label. 

 

In the use of focusing on the following ten aspects 

 

1. Whether to set up medical device quality management agencies or quality management personnel; 

 

2. Whether the establishment covers the whole process of quality management of medical device industry quality management system; 

 

3. Check the purchasing management system or a file, whether for medical equipment purchasing unified management; 

 

4. Use the product whether the registration certificate of medical equipment, qualified certificate whether is complete; 

 

5. The upstream suppliers of medical equipment management (production) permit (production) scope is covering the product; 

 

6. Incoming inspection record whether meet the requirements of the traceability; 

 

7. Whether to build using the record and ensure the record forever; 

 

8. Medical planted instruments are consistent with the actual usage, the use of the system, using the record whether meet the traceability requirements; 

 

9. The key technical parameters such as medical planted instruments is closely related to the quality and safety of information (such as product bar code, etc.) should record the cases; 

 

10. Whether to establish a system for monitoring adverse events related, whether to determine organization, personnel, such as the discovery of adverse events, the report is related to workflow, and to carry out the monitoring work. 

 

Document requirements, check varieties to achieve 100% coverage checking type, 100% coverage of implantable medical device operation enterprise and use the unit, 100% coverage using units involved in the department of medical planted instruments. 

 

Alleged violation, have to initiate an investigation; Illegal if the circumstances are serious, already affect the product quality and safety, should be in accordance with the law must be closed for holiday; Case investigation results must be open to the society; Illegal problems relating to the related department to transfer in time.