After eleven years, the National Medical Products Administration (NMPA) published on November 4, 2025 a new edition of the Good Manufacturing Practice (GMP) for Medical Devices, officially replacing the 2014 version. The new regulation will enter into force on November 1, 2026, with a one-year transition period.

With this measure, as stated by the NMPA, the objective is to comprehensively strengthen the quality management systems of medical device companies and promote their overall improvement. This revision represents a historical update, forming part of the Chinese government’s broader regulatory modernization program aimed at strengthening the medical device sector.

While aligning more closely with major international frameworks—such as ISO 13485:2016, Regulation (EU) 2017/745, and the 21 CFR Part 820—the new GMP still retain distinctive elements reflecting the priorities of the Chinese regulatory environment.

What changes in the new GMP?

The updated GMP are structured into 15 chapters and 132 articles, representing a significant expansion of the regulatory scope compared with the 2014 version.

Among the most notable additions are three new chapters dedicated to:

• Quality Assurance

• Verification and Validation

• Contract Manufacturing and Outsourcing

The overall regulatory framework reflects a deeper integration of risk management concepts and requirements for building robust quality systems, also incorporating aspects related to digitalization and intelligent manufacturing.

The five key directions of the reform

Lifecycle risk management

Risk-based thinking becomes a structural principle. The NMPA requires consistency from research and development through post-market surveillance, with documented, risk-proportionate, and verifiable controls.

Strengthening the Quality Assurance System

The new approach focuses on stability, repeatability, and control of manufacturing processes.
The role of management in overseeing the Quality Management System (QMS) is reinforced, aligning with international best practices.

Advanced governance of contract manufacturing

China is increasing management requirements for emerging business models, such as contract manufacturing. Responsibilities across each operational phase are defined more clearly to ensure high safety standards across the entire production chain.

Validation and verification as inspection pillars

Process validation, change control, and conformity verification become high-priority areas for inspections.
Particular attention is given to special processes and critical outputs.

Digitalization and intelligent manufacturing

The new GMP encourage the structured adoption of Artificial Intelligence and decision-support algorithms, integrated information systems, and the Unique Device Identification (UDI) system to enable advanced traceability.

Implications for manufacturers

The new GMP represent a paradigm shift in NMPA inspections. The regulatory approach moves from simple document verification to a deeper, practical, evidence-based method, assessing how GMP requirements are actually integrated into daily operations.

Foreign manufacturers should consider that:

• Registrations will increasingly reference Chinese GMP requirements, even for imported devices.

• Chinese GMP will need to become an integral part of the company’s QMS, rather than a separate appendix.

• Traceability of requirements must be demonstrable, with clear mappings between GMP articles, implemented controls, and records.

• Outsourcing responsibilities will be closely scrutinized, including evidence of supervision over partners, even those located outside China.

• Digitalization may become a competitive advantage, particularly during inspections.

In summary, compliance in China is evolving into a dynamic, evidence-based system. Authorities increasingly expect concrete examples of risk management, full traceability of design control decisions, and robust management of changes and validations.

For companies operating in the Chinese market, reviewing and updating the Quality Management System according to the new GMP guidance will be essential to ensure continuity, compliance, and regulatory credibility.

Complife can support your Medical Devices in entering the Chinese market while ensuring full compliance with NMPA regulations.

Source:
Announcement of the NMPA on the Release of the Good Manufacturing Practice for Medical Devices ([2025] No. 107).