In order to fully implement the main responsibility for the quality and safety of medical device registrants (hereinafter referred to as registrants) and effectively prevent and control the quality and safety risks of medical devices, the announcement makes the following requirements for registrants:
1. Strictly implement the main responsibility of medical device registrants
(1) The registrant shall fully implement the main responsibility for the quality and safety of medical devices, establish a quality management system covering the whole life cycle of medical devices and maintain effective operation. If the registrant entrusts production, it shall establish and improve a management organization suitable for the characteristics of the products entrusted and the scale of the enterprise, fully perform the responsibilities of product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring and product recall, and regularly review the operation of the quality management system of the entrusted production enterprise in accordance with the medical device production quality management standards.
When the registrant only entrusts production, it shall also maintain the quality management ability of the whole life cycle of the product, maintain the integrity and effectiveness of the quality management system; set up a management organization suitable for the entrusted production, and at least clarify the responsibilities of relevant departments such as technology, production, quality management, adverse event monitoring, after-sales service, etc., and the quality management department shall be set up independently, equipped with a sufficient number and ability of full-time quality management personnel, as well as familiar with products, Technicians with the appropriate expertise are able to effectively monitor and control contract production activities.
The registrant shall be able to bear the responsibility for the quality and safety of medical devices in accordance with the law, and encourage the establishment of liability compensation capacity that matches factors such as the degree of product risk, market size and personal injury compensation standard through the purchase of commercial insurance and other forms.
(2) The registrant shall give priority to enterprises with a high level of quality management, large production scale, good credit record, high degree of production automation and information management as the entrusted party. Before consignment production, the registrant shall require the entrusted party to submit a credit statement and consult the public information of the regulatory department to fully understand the credit status of the entrusted party.
(3) For implantable medical devices, if the registrant is encouraged to produce on his own, and it is really necessary to carry out commissioned production, during the entrusted production activities, the registrant shall, in principle, select personnel with production quality management experience in relevant fields and familiar with the product production process and quality control requirements to settle in the entrusted production enterprise, conduct on-site guidance and supervision of key aspects of production management and quality management, and ensure that production is organized in accordance with regulations, rules, normative documents, mandatory standards and registered product technical requirements. The job responsibilities of the resident personnel shall be specified in the quality agreement. The products in the "Catalogue of Medical Devices Prohibited from Commissioned Production" shall not be commissioned for production.
(4) The registrant shall sign a quality agreement with the entrusted manufacturer in accordance with the requirements of the "Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices" and in combination with the actual situation of the enterprise, and in principle, the validity period of the quality agreement shall not exceed the validity period of the product registration certificate and the production license of the entrusted production enterprise. On the premise of complying with the requirements of relevant laws and regulations, the registrant and the entrusted manufacturer may agree on the specific implementation methods of document control, procurement control, process control, inspection control, product release, change control, etc. in the quality agreement, but the communication and connection requirements must be clarified.
(5) The registrant shall, in conjunction with the entrusted production enterprise, transform the relevant requirements of the quality agreement into executable management documents related to entrusted production, and supervise the implementation of the entrusted production enterprise. Encourage enterprises to adopt controlled information systems to optimize the management process related to entrusted production and improve the efficiency of quality management.
The registrant and the entrusted production enterprise shall review the suitability, adequacy and effectiveness of the quality agreement every year, and confirm that the relevant requirements of the quality agreement are consistent with the entrusted production management documents and the actual production situation. Where inconsistencies are discovered, corrective measures shall be promptly employed.
(6) The registrant shall, in conjunction with the entrusted production enterprise, determine the management method of the purchased goods and suppliers according to the degree of impact of the purchased goods on the products. For key procurement items or main raw materials, such as animal-derived raw materials, outsourced sterilization processes, key components/components/assemblies of active products, antigens and antibodies for in vitro diagnostic reagents, etc., which are procured by the entrusted manufacturer, the registrant shall determine the procurement acceptance criteria and review the relevant suppliers on its own or in conjunction with the entrusted manufacturer.
(7) If the entrusted products share production sites or production equipment with other products (including different varieties, specifications, models, etc.), the entrusted production enterprise shall establish a corresponding management system based on the principles of product quality risk management, risk control measures and overall balance of benefits, so as to prevent possible risks such as product or material confusion, cross-contamination, and misuse of process parameters. The registrant shall strengthen the supervision and guidance of the entrusted production enterprises to ensure that relevant risk control measures are in place.
(8) When the registrant entrusts production, it shall establish product release procedures, clarify the release standards and conditions, review the production process records, quality inspection results and production release documents of the entrusted production enterprise of the medical device, and if the standards and conditions are met, it can only be listed after being signed by the authorized release personnel. The release of products on the market shall be completed by the registrant himself/herself, and other enterprises shall not be entrusted to release the product.
The entrusted production enterprise shall establish production release procedures, clarify the standards and conditions for production release, review the production process of medical devices, inspect the products, and confirm that they meet the standards and conditions before they can be produced and released.
The record retention period for product marketing release and production release shall comply with the relevant requirements of medical device manufacturing quality management practices.
(9) The registrant shall, in conjunction with the entrusted production enterprise, clarify the communication mechanism for corrective and preventive measures, the responsibilities of both parties and the disposal requirements in the quality agreement, and formulate corrective and preventive control procedures appropriate to the product risk. In the event of a trending, systematic or sudden problem such as a significant decrease in product quality compliance, unqualified intermediate products or finished products in successive batches, and risk events in post-marketing risk management exceeding the acceptable criteria, the registrant shall jointly investigate and analyze the problems found with the entrusted manufacturer, formulate and review the corrective and preventive action plan, implement relevant measures and evaluate the effectiveness of the measures.
(10) The registrant shall strengthen the change control capability, establish and improve the change control procedures in conjunction with the entrusted production enterprises, and do a good job in the assessment, verification or confirmation of the change. For the introduction or change of outsourcing suppliers such as commissioned R&D, production process outsourcing and service outsourcing, it shall be determined through risk assessment whether the relevant changes affect the effective operation of the quality management system, and change control shall be done.
(11) The registrant of the entrusted production shall, in accordance with the provisions of the "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices" and other provisions, combine the risk characteristics of the product, allocate sufficient resources, improve the mechanism, strengthen the ability in the construction of the institutional system, institutional staffing, information collection and reporting, event investigation and disposal, risk research and evaluation, etc., and effectively assume the responsibility of monitoring the adverse events of medical devices, and stipulate in the quality agreement the responsibilities and obligations of both parties in the investigation and disposal of adverse events. The adverse event monitoring responsibilities that registrants should perform under the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations shall not be transferred to the entrusted manufacturer through quality agreements.
2. Effectively strengthen the registration management of entrusted production of medical devices
(12) If the registrant (applicant) entrusts production, it shall clearly include the relevant processes of the entrusted production enterprise in the quality management system document of the registered person in the coverage of the quality management system of the registrant, and cover the procedures and related materials for the entrusting party to measure, analyze and improve the entrusted party in the "quality management system document - measurement, analysis and improvement procedures of the quality management system" submitted by the registration declaration.
(13) If the production address of a medical device in China is changed and the production scope of the entrusted production enterprise can cover the entrusted production varieties, and does not involve a change in the production license, a statement issued by the drug regulatory department where the entrusted production enterprise is located shall be submitted when filing for the change of registration certificate.
If the registrant no longer engages in commissioned production, it shall promptly reduce the entrusted production address to the original registration department, and the entrusted manufacturer shall promptly report the relevant situation to the local provincial drug regulatory department.
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Download the relevant file templates
1. Record form for commissioned production of medical devices
2. Contract for commissioned production of medical devices
3. Self-assurance statement on the authenticity of the application materials for the record of entrusted production of medical devices
4. The document template of the quality management system of the third class of medical device wholesale enterprises
5. Quality management system document template for Class I and Class II medical device wholesale enterprises
6. Quality management system document template for Class I and Class II medical device chain management enterprises
7. Quality management system document template for Class I and Class II medical device retail enterprises
8. Complete template of quality records of medical device manufacturers
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