Guidelines for Quality Management of Surgical Robot Production in Beijing Inspection Guidelines (2025 Edition)
Release Date: April 3, 2025
The surgical robot, which refers to the auxiliary surgical equipment utilizing robotic technology, is a highly integrated medical device whose safety, effectiveness, and reliability are directly related to the life and health of patients. To strengthen the supervision of the production of surgical robots, this guideline combines the characteristics of surgical robot products and is based on the requirements of documents such as the “Regulations on the Quality Management of Medical Device Production,” “Guidelines for On-Site Inspection of Medical Device Production Quality Management,” “Appendix on Independent Software of Medical Device Production Quality Management,” and “Guidelines for On-Site Inspection of Independent Software in Medical Device Production Quality Management.” It supplements the special requirements for the production quality management system of surgical robots, aiming to help the medical device production regulatory personnel in Beijing enhance their understanding of surgical robot products and related production quality management, guide and standardize the supervision and inspection of surgical robot registrants and entrusted production enterprises (hereinafter referred to as “production enterprises”), and provide references for relevant production enterprises to carry out production management activities.
When the versions of the national laws, regulations, rules, standards, and inspection guidelines cited in this guideline change, the latest version in effect at that time shall prevail. With the continuous improvement of laws, regulations, rules, and mandatory standards, as well as the continuous development of technological capabilities and cognitive levels, the Beijing Drug Administration will, if necessary, re-study and revise this guideline to ensure that it continues to meet the requirements.
I. Institutions and Personnel
Surgical robot medical devices have high requirements for equipment and software. The assembly, debugging, inspection of equipment, and installation and maintenance of software are critical stages, and production enterprises should be equipped with appropriate personnel.
1. R&D Department. Production enterprises should confirm R&D personnel responsible for the design, development, algorithm research, and design verification and validation of surgical robots. R&D personnel should have relevant professional backgrounds or work experience and be familiar with cutting-edge technologies in the field of surgical robots.
2. Production Department. Production enterprises should confirm the number of production personnel according to the production scale. The production department is mainly responsible for the assembly and debugging of surgical robots. Production personnel should have backgrounds or work experience in electromechanical, software, automation, etc., and be familiar with the production processes, equipment operation, and quality control standards of relevant positions.
3. Quality Control Department. Production enterprises should confirm the number of quality control personnel according to the production scale, mainly responsible for the quality inspection of surgical robots. Quality control personnel should have backgrounds in electromechanical, software, automation, electronic information engineering, biomedicine, quality inspection, etc., and possess corresponding quality control experience and relevant professional knowledge, being able to proficiently use various testing equipment and tools.
4. After-Sales Service Department. Production enterprises should confirm the number of after-sales service personnel according to the sales scale, mainly responsible for the installation, debugging, maintenance, and troubleshooting of surgical robots. After-sales service personnel should have professional knowledge, good communication skills, and service awareness, being able to respond promptly to user needs.
II. Factory and Facilities
Production enterprises should have a working environment and infrastructure suitable for the production of surgical robots, with production capacity that meets the product’s production scale and quality management requirements.
1. The area, lighting, temperature, humidity, and ventilation conditions for production, inspection, and storage should meet production needs, equipped with facilities for pest control, rodent control, dust control, and static electricity prevention.
2. Necessary soundproof rooms, lead rooms, fluorescent rooms, as well as smoke exhaust ducts and sealed dust boxes should be equipped according to product characteristics.
3. Welding processes should be equipped with appropriate smoke exhaust and dust removal facilities to prevent pollution to the production environment; dust prevention facilities for gluing processes should be able to prevent pollution to the gluing process from the production environment.
4. The raw material warehouse should meet the special storage requirements for key raw materials such as optical tracking devices, infrared cameras, robotic arms, sensors, industrial computers, motors, and brakes. Storage of electronic components such as circuit boards should have anti-static measures and avoid direct sunlight.
III. Equipment
Production enterprises should equip relevant equipment and process equipment required for production and inspection according to the characteristics of surgical robot production and establish corresponding records. They should formulate relevant procedures for the operation, use, and maintenance of equipment and process equipment used in production and inspection, and keep corresponding records.
1. They should be equipped with production and inspection equipment and process equipment that match the surgical robots being produced. Important process equipment should be confirmed before first use, and regularly re-confirmed after use, keeping corresponding records. Inspection tools related to product precision control should be managed as important process equipment.
2. An inventory of important process equipment should be established, including the name of the process equipment, equipment number, main functions, maintenance frequency, and other information.
3. Operators of special inspection equipment (such as coordinate measuring machines, visual dimension inspection equipment) should receive training in equipment operation and keep corresponding records.
IV. Design and Development
Production enterprises should conduct design and development and document management according to the design and development control procedures.
1. Production enterprises should establish design and development control procedures based on the characteristics of surgical robot products and document them, planning and controlling the design and development process of surgical robots.
2. The design and development documents of production enterprises should be reviewed or approved within the specified time period according to the task plan.
3. During the transition of design and development, verification and confirmation of production and inspection process equipment and tools, as well as special processes, should be conducted.
4. Key verification and confirmation should be conducted for software involved in the production and use of surgical robots (including but not limited to independent software, dedicated software, embedded software, etc.), as well as key raw materials such as robotic arms. The software development process should comply with the requirements of the “Appendix on Independent Software of Medical Device Production Quality Management,” including functional testing, performance testing, compatibility testing, etc. Additionally, attention should be paid to whether parameters such as precision and speed in the design and development output performance meet relevant functional and safety requirements, and whether the process parameters in the production operation guidance documents can effectively guide the production process.
5. If there are design changes during the design and development process (such as design changes based on type inspection results or changes in raw materials), they should be managed according to design change requirements; design changes after the surgical robot product has obtained registration certificates should be managed according to the change process specified in the enterprise’s production quality management system, and should be reviewed, verified, and confirmed before the change takes effect. The risks arising from the changes should be fully assessed regarding their impact on product safety and effectiveness, and if necessary, an application for product registration change should be submitted.
V. Procurement
Production enterprises should establish procurement processes, material classification, and procurement record requirements that are suitable for key materials of surgical robots, and have the capability for supplier management, procurement verification and confirmation, and safety and effectiveness support analysis of core components that comply with the product’s key materials.
1. Material classification management. Procurement of relevant raw materials should be classified based on their support level for the overall safety and effectiveness of the device and the degree of quality safety risk. Key raw materials such as robotic arms, optical tracking devices, end effectors, industrial computers, sensors, and magnetic field generators should be managed as important raw materials, with a focus on whether mechanical performance, electrical safety, electromagnetic compatibility, and reliability meet product design requirements.
2. Supplier management. Production enterprises should manage suppliers with reference to the “Supplier Audit Guidelines for Medical Device Production Enterprises” issued by the former State Food and Drug Administration. For purchased products that involve the safety of the final product, records of supplier control should be kept.
VI. Production Management
Based on the production characteristics of surgical robot products, production enterprises should focus on the following aspects during the production management process.
1. Confirmation and record-keeping should be conducted for key processes or special processes involved in the production of surgical robots, such as calibration, welding, and engraving, including verification, confirmation plans, methods, operators, result evaluations, and re-confirmation.
2. Production records should maintain traceability. When different production tools with the same name are used in different production processes, the different tools used should be identified.
3. Management requirements should be established for electronic data related to the inspection process of surgical robots, including the establishment of data archives, storage paths, storage time, storage media, anti-tampering, and data backup.
4. Protective requirements for products and their components should be specified, such as contamination protection, static electricity protection, dust protection, corrosion protection, and transportation protection. Protective measures include but are not limited to labeling, handling, packaging, storage, and protection.
5. If the production of surgical robot products also involves the production of independent software, it should comply with the relevant production management requirements of the “Appendix on Independent Software of Medical Device Production Quality Management.”
VII. Quality Control
Production enterprises should determine quality control requirements throughout the entire product realization process, including procurement, production processes, and finished product inspection, based on regulatory requirements, risk management requirements, product technical requirements, characteristics of surgical robot products, production scale, process characteristics, and quality management capabilities. The following aspects should be focused on in quality control:
1. Environmental parameters such as temperature and humidity in the inspection room/area should be controlled to avoid adverse effects on equipment precision detection.
2. Incoming inspection, process inspection, and finished product inspection procedures should be formulated based on mandatory standards, registered product technical requirements, product delivery requirements, and internal control standards of the enterprise, ensuring that each product meets acceptance criteria.
3. The finished product inspection should generally cover the inspection items and methods that need regular control in the registered product technical requirements. If not covered, it should be explained in the finished product inspection procedures, which can be conducted through raw material inspection or process inspection, or through periodic inspection or by entrusting third-party inspection agencies.
In principle, the performance inspection items for navigation-type surgical robots should at least include the precision of the device system under navigation guidance; the performance inspection items for master-slave operation-type surgical robots generally should include: operational distance accuracy, operational distance repeatability, master-slave operation posture accuracy, operational posture repeatability, master-slave control delay time, and other indicators; non-master-slave operation surgical robots should refer to the relevant inspection items set for master-slave operation surgical robots.
4. Software that affects the detection results (such as software used for laser trackers, coordinate measuring machines, visual measurement instruments, etc.) should be confirmed before use and managed by designated personnel, with access permissions such as account passwords set; when software changes, version updates, or computer virus infections occur, the enterprise should conduct re-confirmation.
5. For frequently used and easily damaged equipment and process equipment, such as coordinate measuring machines, precision testing phantoms, reference standards, etc., in addition to regular measurement/calibration, a periodic verification procedure should be established based on actual conditions, specifying the verification cycle, verification items, and verification methods, and keeping records.
6. The quality control requirements for software included in surgical robot products, such as surgical planning software, navigation and positioning software, and operation control software, should be implemented according to the relevant provisions in the “Appendix on Independent Software of Medical Device Production Quality Management.” Key attention should be paid to the real-time and high-precision control of related software, image processing and 3D reconstruction, robot path planning and obstacle avoidance, redundant emergency stop, remote control signal delay, data security and privacy protection, as well as management in aspects such as human-computer interaction interface, algorithm verification and clinical compliance, AI-assisted decision-making, virtual model simulation, and interdisciplinary development.
VIII. Sales and After-Sales Service
1. The sales records of production enterprises should document the specifications, models, and other relevant information of optional components, and remain consistent with the registered product technical requirements, traceable to the included independent software and software components.
2. The transportation methods for surgical robots are divided into whole transportation and split transportation based on size. Production enterprises should take corresponding packaging and protection measures to ensure that products are not damaged during transportation. Whole transportation should consider the impact of vibrations during transportation on equipment precision; split transportation should consider the impact of on-site installation and debugging activities on the precision of equipment (such as robotic arms).
3. For activities involving installation, enterprises should prepare operation guidance documents for medical device installation and acceptance criteria after installation and debugging, clarifying management requirements for installation and debugging. Relevant requirements should at least cover product safety, system functionality, and related precision testing, and clearly specify relevant testing methods and the equipment or process equipment used.
4. Production enterprises should provide professional training to the users of surgical robots, covering at least the basic operation of surgical robots, applicable scope, and methods for addressing issues.
IX. Adverse Event Monitoring, Analysis, and Improvement
1. Adverse Event Monitoring
Production enterprises should establish a medical device adverse event monitoring system and procedural documents according to relevant regulatory requirements, designate a specialized institution, and equip dedicated personnel for management (such as formulating job descriptions for medical device adverse event monitoring, organizational charts, clarifying the main responsibilities of monitoring departments and personnel, etc.). For adverse events occurring after the market launch of surgical robot products, such as significant navigation deviations, poor communication between devices, inaccurate monitoring data, component detachment, abnormal operation, unexpected movements, and data transmission delays, timely collection, investigation, analysis, evaluation, and handling should be conducted according to relevant requirements.
Production enterprises should monitor the safety of surgical robot products after market launch and manage risks, reporting relevant event investigations, analyses, evaluations, and product risk control situations to the drug supervision and management department as required, and keeping relevant work records and archives.
2. Analysis and Improvement
Production enterprises should regularly review and analyze historical data, including product quality, customer complaints, maintenance and repair, evaluate the results of the analysis, promptly identify adverse trends, and propose whether corrective and preventive measures are needed, or whether re-confirmation or re-validation measures should be taken, and complete rectifications in a timely and effective manner.
References
1.YY/T 1901-2023 “Requirements and Test Methods for Orthopedic Surgical Navigation Equipment Utilizing Robotic Technology”
2.YY9706.277-2023 “Medical Electrical Equipment Part 2-77: Special Requirements for Basic Safety and Basic Performance of Auxiliary Surgical Equipment Utilizing Robotic Technology”
3.YY/T 1712—2021 “Auxiliary Surgical Equipment and Systems Utilizing Robotic Technology”