Chapter 13, "Sales and After-Sales Service," introduces significant optimizations to the management responsibilities within the medical device distribution chain while maintaining continuity of core requirements. Through structural adjustments and content refinement, this chapter further reinforces the primary responsibilities of the registrant and the filing person.

I. Continuity and Optimization of Core Requirements

The new Article 116 maintains the basic requirements for sales records while adding a requirement to record the "Unique Device Identification (if available)." This change systematically aligns with UDI management requirements from preceding chapters, reflecting the regulatory authorities' systematic approach to advancing whole-lifecycle traceability management for medical devices. As crucial evidence of product distribution, the enhanced content of sales records will significantly improve the precise identification and traceability of medical devices during the distribution phase.

Articles 117 and 118 retain the original requirements for after-sales service, installation, and maintenance. This continuity underscores the regulatory authorities' ongoing emphasis on these core quality management requirements. The necessity of possessing appropriate after-sales service capabilities, establishing service systems, managing service records, defining installation requirements, clarifying acceptance criteria, and providing technical support – these foundational requirements continue to be stressed in the new regulations, indicating their enduring importance in ensuring medical device safety and effectiveness.

II. Adjustment and Deepening of Regulatory Focus

A significant change in the new regulations is the streamlined integration of original clauses. The deletion of the original Article 63, which contained specific requirements for supervising operating enterprises, does not signify a dilution of related responsibilities. Instead, it reflects an optimization of the regulatory approach – concentrating regulatory focus more squarely on responsible entities such as registrants and filing persons. Enterprises must still ensure compliance throughout the entire product sales process via a sound quality management system.

Concurrently, the new regulations integrate requirements concerning the handling of nonconforming products discovered after sale from the original "Control of Nonconforming Products" chapter, along with relevant customer feedback handling requirements, into the overall quality management system framework. This integration clarifies the internal logic of the quality management system, emphasizes the organic connection between after-sales service and quality management, and encourages enterprises to adopt a more systematic quality management mindset.

III. Implementation Priorities and Compliance Recommendations

Based on the characteristics of the new requirements, enterprises should prioritize advancing work in the following areas: First, ensure the robustness of the sales management system, particularly establishing mechanisms for accurately recording and managing UDI information. Second, continue maintaining the effective operation of the after-sales service system, ensuring service quality and record completeness. Third, pay special attention to quality control in specific segments such as installation and maintenance, providing adequate technical support to user units.

During implementation, it is recommended that enterprises use the release of the new regulations as an opportunity to conduct a systematic assessment of their existing sales and after-sales service systems. Although core requirements remain stable, enterprises should optimize and upgrade related processes by incorporating other new requirements from the quality management system, such as UDI management and whole-lifecycle quality management. Furthermore, training for relevant personnel should be strengthened to ensure they fully understand the quality requirements and possess the corresponding execution capabilities.

A comparison of the content of Chapter 13 between the old and new versions of the "Medical Device Production Quality Management Guifan" is appended below.