In order to implement the Regulations on the Supervision and Administration of Medical Devices, fully implement the medical device registrants (belowThe main responsibility of quality and safety, further strengthen the supervision and management of the production entrusted by the registrant, and effectively prevent and control the quality and safety risks of medical devices。The relevant notice is as follows:
First, 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。Commissioned by the registrant，It shall establish and improve a management organization that is compatible with the characteristics of the products and the scale of the enterprises to be commissioned，Fully perform product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring and product recall responsibilities，Regularly audit the operation of the quality management system of the entrusted production enterprise in accordance with the quality management standards of medical device production。
When the registrant only commissioned production, it shall also maintain the quality management ability of the product throughout the life cycle and maintain the integrity and effectiveness of the quality management system;Set up a management organization suitable for commissioned production，At least clarify the responsibilities of relevant departments such as technology, production, quality management, adverse event monitoring, and after-sales service，The quality control department shall be set up independently，Equipped with sufficient quantity and ability of full-time quality management personnel，And familiar with the product, with the corresponding professional knowledge of technical personnel，Ability to effectively monitor and control commissioned 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 capabilities matching factors such as the degree of product risk, market size and personal injury compensation standards through the purchase of commercial insurance。
(2) The registrant shall preferentially select enterprises with higher quality management level, larger production scale, good credit record, and higher production automation and information management level as the trustee。Before commissioning production, the registrant shall require the agent to submit a statement of credit status, and consult the public information of the regulatory authority to fully understand the credit status of the agent。
(3) For implantable medical devices，Registrants are encouraged to produce their own，It is really necessary to carry out commissioned production，During commissioned production activities，In principle, the registrant shall select personnel with experience in production quality management in relevant fields and familiar with product production process and quality control requirements to settle in the entrusted production enterprise，Provide on-site guidance and supervision for key links of production management and quality management，Ensure that production is organized in accordance with laws, regulations, normative documents, mandatory standards and registered product technical requirements。The job responsibilities of accredited personnel should be clearly defined in the quality agreement。The products in the List of Prohibited Medical Devices 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 Entrusted Production of Medical Devices" and in combination with the actual situation of the enterprise. 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 manufacturer。On the premise of meeting the requirements of relevant laws and regulations, the registrant can agree with the entrusted production enterprise in the quality agreement on the specific implementation of document control, procurement control, process control, inspection control, product release, change control, etc., but must clearly communicate and connect the requirements。
(5) The registrant shall, together with the entrusted production enterprise, convert the relevant requirements of the quality agreement into enforceable management documents related to entrusted production, and supervise the implementation of the entrusted production enterprise。Enterprises are encouraged to use controlled information systems to optimize management processes related to commissioned production and improve quality management efficiency。
The registrant and the entrusted production enterprise shall annually review the suitability, adequacy and effectiveness of the quality agreement and confirm that the relevant requirements of the quality agreement are consistent with the entrusted production management documents and the actual production situation。If any inconsistency is found, corrective measures shall be taken in a timely manner。
（六The registrant shall, together 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 product。For key procurement items or major raw materials，Such as animal-derived raw materials, outsourced sterilization processes, key components/components/components of active products, antigens and antibodies of in vitro diagnostic reagents, etc，Procured by an entrusted production enterprise，The registrant shall, by itself or jointly with the entrusted production enterprise, determine the procurement acceptance standards and review the relevant suppliers。
(7) The entrusted products share production sites or production equipment with other products (including different varieties, specifications, models, etc.)，The entrusted production enterprise shall be based on the principles of product quality risk management, risk control measures and overall balance of income，Establish a corresponding management system，Prevent possible product or material confusion, cross-contamination, misuse of process parameters and other risks。The registrant shall strengthen the supervision and guidance of the entrusted production enterprise to ensure that the relevant risk control measures are put in place。
(8) When the registrant entrusts production, it shall establish product listing release procedures, clarify release standards and conditions, review the production process records of medical devices, quality inspection results and production release documents of the entrusted manufacturer, and if the standards and conditions are met, the authorized release personnel can sign before listing。The product listing release shall be completed by the registrant itself, and shall not entrust other enterprises to list release。
The entrusted manufacturer shall establish production release procedures, clarify the standards and conditions for production release, audit the production process of medical devices, inspect the products, and confirm that the standards and conditions are met before production release。
The record keeping period of product marketing release and production release shall meet the relevant requirements of medical device production quality management norms。
(9) The registrant shall, in conjunction with the entrusted production enterprise, clarify the communication mechanism for corrective and preventive measures, the responsibilities and disposal requirements of both parties in the quality agreement, and develop corrective and preventive control procedures appropriate to product risks。The product quality conformity has a significant decrease trend，Consecutive batches of intermediate or finished products are unqualified，When the risk events in post-listing risk management exceed the acceptable criteria and other trend, systemic and sudden problems，The registrant shall, together with the entrusted production enterprise, investigate and analyze the problems found，Develop and review corrective and preventive action plan，Implement relevant measures and evaluate their effectiveness。
(10) The registrant shall strengthen the ability of change control, jointly with the entrusted production enterprise, establish a sound change control procedure, and do a good job of change evaluation, verification or confirmation。For the introduction or change of outsourcing suppliers such as commissioned research and development, production process outsourcing and service outsourcing, risk assessment should be conducted to determine whether the relevant changes affect the effective operation of the quality management system and do a good job of change control。
(11) The registrant of commissioned production shall comply with the provisions of the Measures for the Management of Adverse Event Monitoring and ReEvaluation of Medical Devices，Combine product risk characteristics，In terms of system construction, institutional staffing, information collection and reporting, incident investigation and disposal, risk research and evaluation，Allocate sufficient resources, improve the mechanism and strengthen the capacity，Effectively assume responsibility for monitoring adverse events of medical devices，In the quality agreement, the responsibilities and obligations of the entrusted parties in the investigation and disposal of adverse events are agreed。The adverse event monitoring responsibility that the registrant should perform as stipulated in the Regulations on the Supervision and Administration of Medical Devices and other regulations shall not be transferred to the entrusted manufacturer through the quality agreement。
Second, effectively strengthen the registration management of medical device commissioned production
(12) Production commissioned by the registrant (applicant)，The relevant processes of entrusted production of the entrusted production enterprise shall be clearly included in the quality management system of the registrant in the quality management system，In addition, the "Quality Management System Document-Measurement, analysis and improvement procedures of Quality management System" submitted in the registration application shall cover the procedures and related materials of the entrusting party for the measurement, analysis and improvement of the entrusted party。
When carrying out the verification of the registered quality management system, it should focus on the establishment of the quality management organization of the enterprise, the key personnel of the quality system and the performance of their duties, the signing of the quality agreement, the entrusted research and development and the entrusted production management。Involving domestic cross-regional commissioned production，In principle, the verification of the registered quality management system shall be carried out by the drug regulatory department of the place where the registrant (applicant) is located on its own or jointly entrusted to the drug regulatory department of the place where the manufacturing enterprise is located，Conduct a comprehensive inspection of the quality management system operation of the registered (applicant) and the entrusted production enterprises。Under special circumstances, the drug regulatory department of the place where the registrant (applicant) is located is indeed unable to send inspectors，The local drug regulatory department of the entrusted manufacturing enterprise may be entrusted to verify the entrusted manufacturing enterprise，The drug regulatory department of the place where the registrant (applicant) is located shall examine and confirm the verification report of the entrusted manufacturing enterprise in combination with the verification of the registrant (applicant) system。
(13) Application for registration or renewal of registration involving domestic commissioned production，The registration and approval department shall record the entrusted production address and indicate "(entrusted production)" in the production address column of the medical device registration certificate.，At the same time, note the name of the entrusted production enterprise and the unified social credit code in the remarks column，Note form: "Entrusted production enterprise:XXXX Company;Unified social credit code:XXXX”。Where the change registration involves the registrant's commissioned production, it shall also indicate the relevance of the commissioned production in the change registration document in accordance with the above methodsInformation, and the change information will be updated in the corresponding fields of the production address and remarks of the registration certificate, in accordance with the national drug supervision numberSubmitted according to the data collection requirements of the sharing platform。The registrant and the provincial drug supervision and administration department where the entrusted production enterprise is located shall promptly record the relevant information of the entrusted production in the enterprise credit file。
If the name of the production enterprise is changed in character only, there is no need to apply for the change of the record, and the revised registration certificate shall be issued when the registration is renewed。
各The provincial drug regulatory department shall organize the registration certificate of commissioned production that has been issued within the administrative region to comb, and find that the relevant information is not marked in accordance with the above requirements, shall urge the registrant to apply to the original registration department for marking in a timely manner, and complete the marking within 3 months from the date of implementation of this announcement。
（十四）境内If the production address of medical devices is changed and the production scope of the entrusted production enterprise can cover the entrusted production varieties, and the production license is not changed, registration shall be handledWhen filing a certificate change, a statement issued by the drug regulatory department where the entrusted manufacturer is located shall be submitted。
If the registrant no longer engages in commissioned production, it shall promptly reduce the commissioned production address to the original registration department;The entrusted manufacturer shall promptly report the relevant situation to the local provincial drug regulatory department。
Third, continue to strengthen the supervision and management of commissioned production
(15) The provincial drug supervision and administration department shall effectively implement the territorial supervision responsibility，Through collecting registration certificate information of commissioned production, urging enterprises to report production varieties, receiving cross-regional production varieties notification and other ways and means，Comprehensively sort out and master the number of various types of registrants and entrusted production enterprises in the administrative region，In accordance with risk management principles，We will strengthen targeted oversight。
The provincial drug supervision and administration department where the registrant is located shall continue to pay attention to the registrant's quality management ability for the whole life cycle of medical devices, the evaluation and control ability of the entrusted manufacturing enterprise, and the change management ability, and verify the information provided by the registrant in combination with the inspection of the entrusted manufacturing enterprise。The provincial drug supervision and administration department where the entrusted manufacturing enterprise is locatedIt shall continue to pay attention to the production and quality management of the entrusted products, and urge the entrusted production enterprises to comply with laws, regulations, normative documents, mandatory standards, registered product technical requirements and entrusted production quality cooperationDiscuss and carry out production activities。
(16) Where the registrant changes from self-production to commissioned production, or changes the commissioned production enterprise, it shall promptly report to the provincial drug regulatory department where the registrant is located。The provincial drug regulatory department where the registrant is located shall conduct a comprehensive inspection of the quality management system of the registrant and the entrusted production enterprise, and the inspection of the entrusted production enterprise may be carried out jointly with the provincial drug regulatory department where the entrusted production enterprise is located。
(17) Drug regulatory departments at all levels shall deeply understand the complexity and particularity of the supervision of registrant entrusted production, scientifically equip regulatory resources, and enrich regulatory means。
In areas where registrants of commissioned production are relatively concentrated, the provincial drug supervision and administration department shall, in combination with the development of supervision work, regularly supervise the entrusted production of registrantsConduct special consultation, analyze the results of supervision and inspection and product sampling, and comprehensively investigate the enterprise quality management system and product qualityWe will take targeted prevention and control measures to eliminate systemic and regional risks。
Encourage drug supervision and administration departments to explore the two sites of registrants and entrusted manufacturers to carry out supervision and inspection simultaneously, connect the inspection site through information means such as remote network, communicate inspection information in a timely manner, and unify the inspection scale。
(18) The State Food and Drug Administration continues to promote the construction of medical device variety files and credit files, and promotes the interconnection of registrant entrusted production information by standardizing the registration certificate entrusted production information annotation;The provincial drug supervision and administration department shall realize the information interconnection of the whole chain of medical device supervision within the administrative area，Collect review and approval, registration quality management system verification, production licensing, supervision and inspection, enterprise reports, supervision and sampling, illegal behavior investigation and other information，Continuously update and improve the credit files of registrants and entrusted production enterprises，And according to the requirements of the State Drug Administration pushed to the national drug regulatory data sharing platform，Cross-provincial regulatory information sharing will be gradually realized。
Involving cross-regional commissioned production，The provincial drug supervision and administration department where the registrant and the entrusted production enterprise are located shall comply with the requirements of the "Measures for the Supervision and Administration of Medical Device Production" and "Opinions on Strengthening the collaborative supervision of Cross-regional Entrusted Production of Medical Devices"， Timely reporting of supervisory information such as enterprise production varieties, inspection results and responsibility interviews。
(19) Where the quality management system of the registrant or the entrusted production enterprise is found to be not operating effectively during supervision and inspection, the provincial drug regulatory department shall order it to rectify within a time limit;Where the registrant and the entrusted manufacturing enterprise fail to take effective measures to eliminate the existing quality and safety risks, the provincial drug regulatory department shall promptly take measures such as warning and responsibility interview, and when necessary, the registrant and the provincial drug regulatory department where the entrusted manufacturing enterprise is located may conduct joint responsibility interview。
The registrant and the entrusted manufacturer seriously violated the quality management standards for medical device production，After comprehensive study and judgment, it is considered that the product is safe and effective，Potentially harmful to human health，Provincial drug regulatory departments may take emergency control measures to suspend production, operation and use，And strictly in accordance with the "medical device supervision and Administration Regulations" Article 86 of the punishment。
(20) This Announcement shall take effect as of June 1, 2024。
State Drug Administration
April 2, 2024
