On January 15, 2025, the National Medical Products Administration (NMPA) released the "Medical Device Production Quality Management Guīfàn (Revised Draft for Comments)". This represents the most significant revision since the implementation of the 2014 version and will have a profound impact on the medical device industry. To help companies better understand the regulatory changes, our company has specifically organized this comparison between the old and new versions.

Analysis of Core Changes in the General Provisions

1. More Comprehensive Legal Basis

Article 1 of the new regulation expands the list of laws and regulations it is based upon, adding the "Measures for the Administration of Medical Device Registration and Filing" and the "Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing" as specified references. This indicates the close connection between the new regulation and the overall legal system for medical device supervision, reflecting systematic and consistent regulatory requirements.

2. Significantly Expanded Scope of Application

Article 2 of the new regulation extends the scope of application from merely "medical device manufacturing enterprises" to "medical device registrants, filing persons, and entrusted manufacturing enterprises". It also emphasizes that this Guīfàn must be complied with throughout the entire lifecycle activities of the medical device. This change is significant: firstly, it clarifies the responsible entities, establishing registrants and filing persons as the ultimate responsible parties for product quality, meaning they are accountable for quality even when production is entrusted; secondly, it achieves a whole-process supervision system, ensuring no regulatory gaps in any link; finally, it adapts to industry models, aligning with the current trend of specialized division of labor within the industry and clarifying the boundaries of quality responsibilities for all parties in entrusted production relationships.

3. More Specific System Requirements

Article 3 of the new regulation explicitly includes activities such as "entrusted production, external cooperation processing, and entrusted testing" within the quality management system requirements. This addition emphasizes that the quality management system established by enterprises must comprehensively cover various external collaboration models, and quality requirements cannot be reduced due to outsourcing.

4. Strengthened Risk Management Requirements

Article 4 of the new regulation changes "measures" for risk management to "control measures". This reflects a higher requirement for the effectiveness and execution of risk management, meaning not only must risk measures be taken, but it must also be ensured that these measures can effectively control risks and have practical results.

5. New Principle of Good Faith and Integrity

Article 5 is a new clause concerning integrity. This explicitly writes the principle of integrity into the regulation, reflecting the regulatory authorities' high level of concern regarding industry integrity issues and providing a direct basis for addressing behaviors such as data falsification and false records.

Impact on Enterprises and Response Suggestions

The changes in Chapter 1 of the new regulation reveal a fundamental shift in the mindset behind medical device supervision: moving from control solely over the production link to quality management across the entire lifecycle, and from compliance checks to substantive risk control.

Therefore, enterprises should: redefine quality responsibilities (registrants/filing persons should reassess their quality responsibilities); improve their management systems (ensure the quality management system covers all outsourcing and collaboration links); strengthen risk control (enhance the verification of the effectiveness of risk control measures); and establish an integrity culture (internally emphasize the principle of integrity and establish mechanisms to prevent falsification).

As the general provisions, the changes in Chapter 1 of the revised draft "Medical Device Production Quality Management Guīfàn" clearly convey the direction and expectations of the regulators. Enterprises should deeply understand the regulatory intent behind these changes, prepare in advance, and elevate quality management from "compliance" requirements to "substantive" assurance. Only then can they maintain competitiveness and ensure product safety and effectiveness in an increasingly strict regulatory environment.