Recently, NMPA conducted unannounced inspections of four enterprises and found the following major deficiencies in their quality management systems, which will be divided into several major aspects:
Organization personnel：The person in charge of the enterprise and other relevant management personnel are not familiar with the regulations and cannot make judgment and deal with the problems arising in production management and quality management. At the same time, the enterprises do not have insufficient training of employees on relevant laws and regulations, and the relevant personnel have insufficient ability to recognize product production compliance risks and quality and safety risks. Therefore, the enterprises do not comply with the clause of Good Manufacturing Practice for Medical Device that the personnel engaged in work affecting product quality should be trained to meet the requirements of their positions, with relevant theoretical knowledge and practical skills requirements.
Equipment： The main deficiencies are the issues such as the lack of equipment required for the production of medical protective clothing on site. Enterprises should be equipped with production equipment that matches the products manufactured and the scale of production, and ensure the requirements for effective operation.
Manufacturing management：Specific findings include unreasonable production times in the records; inaccurate information in the material receipt records, the accuracy of sterilization records, etc., which do not meet the requirement that all products should have manufacturing records and be traceable.
Non-conformity control: Failure to dispose of nonconforming products stacked at the site of the raw material warehouse in accordance with the nonconforming product control program, mixing of multiple varieties and specifications, no quantity records, and inability to provide nonconforming product disposal orders.
Design development: Failure to identify mechanism molding as a special process (critical control point) in the process flow diagram; inconsistency between the number displayed on the ammeter of the ultrasonic (acoustic) wave generator of the production equipment in the clean room and the process requirements in the work instructions; failure to provide quality standards for raw materials and a series of other issues. Design and development outputs should meet input requirements, including requirements for relevant information needed for procurement, production and service, and product technical requirements.
Procurement: The number of items shown on the enterprise’s stock cards did not correspond to the number of items actually remaining in the warehouse, and it was not possible to account for the flow of the discrepant portion of the items. In addition, the enterprise was only able to provide the agreement signed with some suppliers, and the agreement did not make relevant provisions on the legality and selection criteria of raw materials in accordance with the technical requirements of the registered products, and the enterprise failed to provide the relevant information on raw material investigation and informed consent. Enterprises should sign quality agreements with major raw material suppliers to clarify the requirements of the quality responsibility borne by both parties. The above issues are not in line with the requirements that procurement records should be traceable.
Quality control: Enterprises have not been developed uniform inspection rules according to product technical requirement, some of the performance indicators of PTR in the production process and release of finished products are not tested. Enterprises should be based on mandatory standards and technical requirements for registration or filing of products to develop product inspection procedures, and issue the corresponding inspection report or certificate requirements. After reviewing the product inspection report, it was found that the report does not record the unit of the number of incoming units, raw materials, original product lot number and production date and other issues, which can not be traced. Products should have batch inspection records and traceability requirements.
Adverse event monitoring, analysis and improvement：Enterprises did not fill in the enterprise product registration information in the enterprise adverse event monitoring system, nor evaluate the adverse events in the system, nor report them by a person in the marketing department in accordance with the requirements of the enterprise adverse event monitoring procedures. Some enterprises have not reported the evaluation results in the system in accordance with the requirement of reporting the evaluation results of serious injury adverse events within 45 working days in the Management Measures of the Monitoring and Reevaluation of Medical Device Adverse Events, although they have provided the paper evaluation materials of serious injury adverse events. The enterprise has not passed the medical device adverse event investigation, analysis, evaluation known by national medical device adverse event monitoring information system, nor take risk control measures, nor release risk information and other disposal requirements. These are not in line with the requirements mentioned in the Good Manufacturing Practice for Medical Device that should establish a medical device adverse event monitoring system in accordance with the requirements of relevant laws and regulations, carry out adverse event monitoring and re-evaluation work, and maintain relevant records.
The quality management system of the above four enterprises has serious defects and does not comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices. The enterprises have confirmed the defects of the above quality management system.
The relevant provincial regulatory departments shall, in accordance with the provisions of Article 72 of the Regulations for the Supervision and Administration of Medical Devices, take control measures in accordance with the law to order the suspension of production; for the defects suspected of violating the Regulations for the Supervision and Administration of Medical Devices, related measures shall be dealt with in accordance with the law; and order the enterprise to assess the safety risk of the product, and if it is likely to lead to a potential safety hazard, recall the relevant products in accordance with the Administrative Measures on Recall for Medical Device. Enterprises to complete all the findings rectification and tested by the provincial regulatory department qualified before resuming production.
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