Chapter 12 is a newly added independent chapter. This chapter systematically regulates medical device entrusted production activities, clarifying the respective quality responsibilities of the entrusting party and the entrusted party. It reflects the regulatory authorities' attention to and standardization of the increasing division of labor within the industry and the development of new industry models.

I. Restructuring and Clarification of the Responsibility System

Article 105 of the new regulation establishes the basic framework for the quality management system of entrusted production. It requires that the entrusting party's quality management system must cover the entire lifecycle of the medical device, while the entrusted party's system needs to include content related to the entrusted production activities. This provision fundamentally clarifies the registrant's position as the ultimate responsible entity for product quality, eliminating the possibility of transferring statutory responsibilities through an entrustment agreement. Simultaneously, it requires both parties to establish effective communication mechanisms to ensure the effective connection and operation of their respective quality management systems.

Article 106 further strengthens the primary quality responsibility of the entrusting party, explicitly stating that the entrusting party cannot transfer obligations and responsibilities that it should legally fulfill through an agreement. This clause ensures that under the entrusted production model, product quality responsibility remains clear and unambiguous, providing a clear basis for regulatory accountability. Furthermore, the clause stipulates that the entrusted manufacturer must not re-entrust the production of the entrusted products, effectively preventing quality risks arising from multi-layer subcontracting.

II. Refinement of Whole-Process Control Requirements

During the implementation of entrusted production, the new regulation introduces specific and stringent management requirements. Article 107 requires the entrusting party to conduct an on-site assessment of the entrusted party before production and to perform regular on-site audits and evaluations after production commences, establishing a continuous supervision mechanism. This ongoing supervision requirement ensures that the entrusted party consistently maintains production conditions and quality assurance capabilities that comply with regulatory requirements.

Regarding personnel allocation, Article 108 sets clear requirements for both parties. The entrusting party needs to equip itself with a sufficient number and competent full-time quality management personnel, as well as technical personnel familiar with the product, to ensure effective guidance and supervision of the entrusted production activities. Key personnel of the entrusted party must be familiar with the specific details of the entrusted production product, ensuring professionalism and specificity during the production process.

III. Strengthening Control of Key Links

Quality control during the production transfer phase receives special attention. Article 109 requires the entrusting and entrusted parties to jointly plan and complete production transfer activities, ensuring the effective transfer of product technical requirements, production processes, etc., and requires the execution of trial production and process validation and verification activities. This regulation ensures a smooth transition from R&D to production, effectively preventing quality risks during the technology transfer process.

The change control requirements reflect the philosophy of whole-process quality management. Article 110 establishes a two-way change control mechanism, requiring the entrusting party to promptly notify the entrusted party of design changes, procurement changes, etc., while also requiring the entrusted party to promptly provide feedback on change requests. This two-way communication mechanism ensures that any changes potentially affecting product quality are handled promptly and effectively.

IV. Improvement of Release Responsibility and Anomaly Handling Mechanisms

The dual control mechanism for release management is a significant innovation in this revision. Article 111 clarifies the dual requirements for the entrusting party to establish a product market release procedure and the entrusted party to establish a production release procedure. It specifically emphasizes that product market release must be completed by the registrant itself and must not be delegated to another enterprise. This provision ensures that the registrant always holds the final release authority for the product, safeguarding the ultimate attribution of product quality responsibility at the institutional level.

The establishment of an anomaly handling mechanism provides institutional safeguards for quality risk control. Article 112 requires the entrusted party to promptly report deviations, changes, and anomalies that may affect product quality to the entrusting party and retain handling records. This requirement ensures the timely discovery and effective handling of quality issues, preventing the escalation and spread of quality risks.

V. Regulation of Outsourced Processing and Entrusted R&D

The new regulation explicitly standardizes outsourced processing and entrusted R&D activities for the first time. Articles 114 and 115 require enterprises to establish outsourced processing control procedures and to manage the outsourced processor at least according to the requirements for supplier management. These provisions bring outsourced processing within the scope of standardized management, ensuring quality control throughout the entire product realization process.

The requirements for entrusted R&D activities reflect the emphasis on the design and development phase. Article 113 clarifies the entrusting party's responsibility to assess the R&D capability of the entrusted party, requires signing an agreement that clearly defines the scope of entrustment and responsibilities, and emphasizes that the entrusting party bears corresponding responsibility for the process and results of the entrusted design and development. This provision ensures the standardization and effectiveness of entrusted R&D activities.

VI. Implementation Suggestions and Response Strategies

Facing the new regulation requirements, it is recommended that enterprises immediately undertake the following tasks: First, systematically review existing entrusted production partnerships and assess compliance gaps against the new regulation requirements. Second, establish and improve a sound document system for entrusted production quality management, particularly quality agreements, management procedures, and record documents. Third, strengthen the construction of the entrusted production management team, equipping it with sufficient quality management and technical personnel. Finally, establish a comprehensive supervision mechanism for entrusted production, including regular audits, performance evaluations, and continuous improvement.

For entrusted manufacturers, the focus should be on improving and perfecting the quality management system adapted to entrusted production, strengthening personnel training to ensure possession of the technical capabilities and quality assurance capabilities required for entrusted production. Simultaneously, establish effective communication mechanisms with the entrusting party to ensure the timely transmission and handling of quality information.

The addition of Chapter 12 reflects the further improvement of the medical device regulatory system, providing clear legal basis and operational guidelines for entrusted production and outsourced processing. Through systematic institutional design, the new regulation both meets the needs of industrial development and ensures product quality and safety. Enterprises should seize this opportunity to optimize resource allocation, enhance product quality levels, and strengthen market competitiveness by standardizing entrusted production management.

Attached at the end is the content of Chapter 12 of the new "Medical Device Production Quality Management Guifan".