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       In 2020, the National Bureau conducted unannounced 宝龙娱乐最新官网s on 89 medical device manufacturers, including 44 IVD companies, 16 sterile product companies, 11 active device companies, 9 implant product companies, 3 denture companies, and 3 independent software company and 3 other companies. The reasons for unannounced 宝龙娱乐最新官网s are compliance 宝龙娱乐最新官网s, special 宝龙娱乐最新官网s, unqualified random 宝龙娱乐最新官网s, complaints and reports, and occurrence of adverse events. The result of the 宝龙娱乐最新官网 was that 63 enterprises were rectified within a time limit, 12 stopped 宝龙娱乐最新官网 for rectification, 8 had stopped 宝龙娱乐最新官网 before the 宝龙娱乐最新官网 and 1 was written off. Among them, 687 failed 宝龙娱乐最新官网s were mainly concentrated in 宝龙娱乐最新官网 management, plant and facilities, equipment and quality 宝龙娱乐最新官网.
In view of the unqualified items of medical device unannounced 宝龙娱乐最新官网s in 2020, the main problems are analyzed as follows:

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• The enterprise is not equipped with full-time inspectors suitable for the products produced;

• The person in charge of 宝龙娱乐最新官网 and quality is concurrently responsible for each other, and at the same time is responsible for product approval and release;

• The 宝龙娱乐最新官网 technicians and full-time inspectors have not carried out training that meets the 宝龙娱乐最新官网 of their positions, and have not seen training content and training 宝龙娱乐最新官网.

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• The plant and facilities cannot meet the 宝龙娱乐最新官网 of product 宝龙娱乐最新官网;

• The exhaust air from the air-conditioning system in the positive 宝龙娱乐最新官网 room is directly discharged into the air-conditioning mezzanine, and the exhaust duct has no filter device. The positive 宝龙娱乐最新官网 room is not maintained negative pressure with the adjacent corridor and other 宝龙娱乐最新官网 rooms;

• The working shoes are cleaned and dried in an operation room in a 10,000-grade clean area. There is no corresponding risk 宝龙娱乐最新官网 method. The gas generated in this process is directly discharged outside, and there is no filter device at the return air outlet;

• Inadequate warehouse management;

• The process water manufacturing equipment is leaking, and a large amount of debris is piled up in the compressed air machine room.

3. Equipment

• The equipment operating parameters specified in the process regulations are inconsistent with the confirmation report and actual 宝龙娱乐最新官网 宝龙娱乐最新官网 parameters;

• The speed range of the automatic drug coating machine has not been verified after adjustment, and the company has not specified the reconfirmation cycle;

• The maintenance of the independent software development and testing environment is not documented, and there are no 宝龙娱乐最新官网 for regular verification, updates and upgrades;

• Lack of equipment usage and maintenance regulations and 宝龙娱乐最新官网.

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• The standard operating procedures for 宝龙娱乐最新官网 of semi-finished products lack preparation methods for positive reference and positive reference nucleic acid extraction and dilution;

• Incomplete 宝龙娱乐最新官网 of some documents and un宝龙娱乐最新官网led modification;

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• Unable to provide design and development output document 宝龙娱乐最新官网, and the design and development output data is inconsistent with the input 宝龙娱乐最新官网;

• Design change management is not in place;

• The company failed to provide review 宝龙娱乐最新官网 of design changes during the product renewal registration phase.

6. Procurement

• Fail to purchase raw materials in accordance with the established "procurement 宝龙娱乐最新官网 procedures", fail to clarify the quality responsibilities of both parties with the main raw material supplier, and the purchase 宝龙娱乐最新官网 cannot meet the traceability 宝龙娱乐最新官网;

• The supplier list does not include major raw material suppliers, fails to provide supplier review reports, review 宝龙娱乐最新官网, and incomplete review 宝龙娱乐最新官网, etc.;

• The 宝龙娱乐最新官网 of incoming materials is not strict.

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• The enterprise fails to organize 宝龙娱乐最新官网 in accordance with the registered process and 宝龙娱乐最新官网 process regulations;

• The 宝龙娱乐最新官网 宝龙娱乐最新官网 are missing or incomplete or inconsistent with regulations, and the 宝龙娱乐最新官网 宝龙娱乐最新官网 cannot meet the traceability 宝龙娱乐最新官网;

• The intermediate products in the 宝龙娱乐最新官网 process have no status mark, and no 宝龙娱乐最新官网 status is marked along with the work order;

• The special process is not identified or confirmed, and the verification parameters are inconsistent with the actual operation.

8. Quality 宝龙娱乐最新官网

• Some 宝龙娱乐最新官网 items and 宝龙娱乐最新官网 methods in the factory 宝龙娱乐最新官网 procedures are inconsistent with product registration standards or technical 宝龙娱乐最新官网;

• The "Product Release Procedure" has not been established, and the product release conditions and release standards have not been specified;

• A manufacturer of sterile products does not have the ability and conditions to detect sterility and positive 宝龙娱乐最新官网s;

• The 宝龙娱乐最新官网 level of the initial contamination of bacteria and particulate contamination of the product has not been established, and the storage conditions and 宝龙娱乐最新官网 of the intermediate product have not been clarified;

• It is not possible to provide a report that summarizes and analyzes the trends of various testing 宝龙娱乐最新官网 on a regular basis;

• Record traceability issues, such as testing 宝龙娱乐最新官网 that cannot meet traceability 宝龙娱乐最新官网; the generation and use of quality 宝龙娱乐最新官网 beads in IVD companies cannot be traced; random 宝龙娱乐最新官网 of a batch of batch 宝龙娱乐最新官网 宝龙娱乐最新官网 does not see irradiation sterilization 宝龙娱乐最新官网, but the products have been sold.

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• The company claims that its products cannot be reworked, but it still retains the content of rework of nonconforming products in its "Control Procedures for Nonconforming Products".

• There are 28 unqualified products with sprayed waste in the outer bag in a batch record of the company, and the company has reworked, but no rework record has been seen;

• The actual rectification measures are inconsistent with the review 宝龙娱乐最新官网.

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• Failure to establish an adverse event monitoring system in accordance with current regulations;

• Failure to implement the recall work in accordance with the required recall plan;

• Failure to evaluate the effectiveness of the rectification measures for the identified problems, which does not meet the 宝龙娱乐最新官网 of the company's "Corrective and Preventive Measures Control Procedures".

      The above are the main problems of unqualified medical device unannounced 宝龙娱乐最新官网s in 2020. It is recommended that companies further enhance their awareness of quality management and risk management; strengthen legal training, continuously improve the quality and level of quality management personnel, and improve the ability to identify risks and 宝龙娱乐最新官网 risks; strengthen Self-宝龙娱乐最新官网 of the system, continuous improvement and perfection of the quality management system.