China NMPA Issues New GMP (Good Manufacturing Practice) for Medical Devices

China’s National Medical Products Administration (NMPA) issued the new “Good Manufacturing Practice for Medical Devices” on November 4, 2025. The updated framework introduces more detailed and stringent requirements for quality management, personnel qualifications, and supply chain control. It also brings outsourced R&D, contract manufacturing, external processing, and entrusted testing fully into the scope of the quality management system.

At a Glance: 2025 GMP for Medical Devices

• Effective date: November 1, 2026, replacing the 2014 GMP in full.
• Scope expansion: Coverage now spans the entire product lifecycle, including outsourced R&D, contract manufacturing, external processing, and entrusted testing.
• Structural update: Reorganized into 15 chapters and 132 articles with more prescriptive requirements.
• Compliance impact: Strengthened expectations for quality assurance, personnel qualifications, facility controls, supplier management, and digital documentation.
• Applicability: Overseas manufacturers and Chinese contract manufacturers must achieve full alignment.
• Regulatory Support: Contact Cisema’s regulatory experts today for interpretation and implementation guidance.

Continue reading for a detailed explanation of the key updates, or click to view the GMP 2014 vs. GMP 2025 comparison table.

Key Changes in China Medical Device GMP 2025

The 2025 GMP introduces a significant upgrade to China’s medical device regulatory framework, setting clearer expectations across the full product lifecycle and raising baseline requirements for quality systems, personnel, facilities, and oversight of external partners.

The following sections summarize the main regulatory changes and highlight priority preparation steps for overseas manufacturers.

Stronger Quality Assurance and Risk Management Expectations

The new GMP introduces a dedicated quality assurance chapter and more prescriptive expectations for lifecycle risk control. These additions require manufacturers to reassess their quality assurance systems and ensure that risk management practices cover all stages of the device lifecycle.

Key changes include:

• A standalone chapter on Quality Assurance (Articles 7–13).
• Requirements to establish a complete quality assurance system spanning design, development, production, distribution, and after-sales service.
• Formal change control procedures requiring risk assessment, review and approval, and verification when necessary.
• Lifecycle risk management based on continuous collection of risk information and regular risk management reviews.

Manufacturers should confirm that their QA structure, change-control processes, and risk management documentation support these expanded controls.

Higher Qualification Requirements For Key Personnel

The 2025 GMP increases competency thresholds for essential roles, particularly within quality and production. Companies working with Chinese facilities or contract manufacturers must ensure key positions meet updated academic and experience criteria.

The regulation requires:

• A management representative for Class II and III devices with a relevant bachelor’s degree or mid-level technical title and at least three years of relevant experience.
• Equivalent qualifications for the head of quality management.
• Full-time staffing for the legal representative, management representative, and quality lead.
• The heads of production and quality management do not hold dual roles.

A review of current staffing profiles and targeted upskilling or recruitment may be necessary to meet these expectations.

Enhanced Facility and Environmental Control Requirements

The updated GMP introduces more detailed requirements for facility layout, environmental parameters, and access control, which may require physical adjustments or re-qualification activities.

Key requirements include:

• Defined cleanroom pressure differentials (>10 Pa between clean and non-clean areas; >5 Pa between clean areas of different grades).
• Production areas must be suitable for the product type and scale to prevent mix-ups and contamination.
• IT systems capable of supporting controlled production and quality processes.
• Production, testing, and storage areas cannot be used as passageways for unrelated personnel.

Manufacturers should assess facility layouts, cleanroom performance, and IT systems to determine upgrade needs.

Stricter Lifecycle Controls for Equipment and Instruments

The regulation formalizes lifecycle management requirements for equipment and measuring instruments, ensuring they remain suitable for use over time.

The regulation requires:

• Documented management from procurement through installation and qualification
• Regular calibration or verification covering actual operating ranges
• Clear status identification to prevent misuse
• Re-qualification after modifications or major repairs

Companies should review equipment files, calibration programs, and change-control procedures to align with these strengthened expectations.

Enhanced Digital Documentation and Data Integrity Requirements

The 2025 GMP requires manufacturers to demonstrate that digital systems supporting production and quality activities are secure, traceable, and reliably maintained.

Key provisions include:

• Formal recognition of electronic records and electronic signatures.
• User access controls with full logging of changes and deletions.
• Data backup obligations and guaranteed readability throughout the retention period.
• Controlled procedures for drafting, approving, updating, and retiring documents.

Manufacturers should verify that electronic systems support audit trails, secure access rights, and compliant document control workflows.

Clearer Design and Development Controls

Design and development controls are now more clearly defined, with stronger expectations for oversight of outsourced activities. These updates are particularly relevant for registrants relying on external design partners.

The regulation emphasizes:

• End-to-end design controls, including planning, inputs, outputs, verification, validation, and documentation.
• Design transfer requirements to ensure that R&D outputs can be reliably scaled to commercial production.
• Oversight of outsourced design, with the contracting company responsible for the contractor’s capabilities and output quality.

Companies should review design control procedures, update design transfer protocols, and validate oversight mechanisms for outsourced R&D partners.

Risk-Based Supplier and Procurement Management Requirements

Supplier management follows a more structured, risk-based approach, with clearer obligations for classification, quality agreements, and change notifications.

The new GMP requires:

• Categorized management of purchasing items based on product quality impact.
• Detailed quality agreements specifying technical requirements and quality responsibilities.
• Advance notice from suppliers regarding changes to critical materials or processes.
• On-site audits conducted according to risk aassessment.

Manufacturers should upgrade supplier evaluation and auditing programs, implement category-based classification, and ensure quality agreements meet Chinese requirements.

Defined Roles and Responsibilities in Contract Manufacturing

The new GMP provides clearer delineation of responsibilities between registrants, record holders, and contracted manufacturers, reinforcing accountability across the supply chain.

Key clarifications include:

• Mandatory, detailed quality agreements defining roles and responsibilities.
• Two-way oversight including on-site evaluations, periodic audits, and prompt deviation reporting.
• Separate release responsibilities: the contracted manufacturer handles production release; the registrant or record holder handles market release. Sub-delegation is prohibited.

Companies should review contract manufacturing agreements, ensure responsibilities are clearly assigned, and establish consistent communication and escalation processes.

Recommended Transition Timeline

The following phased approach can help overseas companies manage the workload - upgrade systems, align procedures, and prepare documentation  - to effectively and ensure readiness by the 2026 deadline.

Preparation phase (now–end of 2025):

• Establish a dedicated GMP transition team
• Conduct detailed gap analysis and training
• Develop an implementation roadmap with resource allocation.

Implementation phase (January–September 2026):

• Update QMS procedures, including supplier, risk, and contract manufacturing controls
• Complete necessary verification and validation activities
• Prepare supporting documentation demonstrating conformity

Consolidation phase (from October 2026 onward):

• Conduct internal audits against updated GMP requirements
• Resolve nonconformities and close open issues
• Maintain compliance through continuous improvement and periodic training

A structured transition will support a smooth compliance pathway and position manufacturers for full conformity with the 2026 regulatory expectations.

Final Thoughts

The 2025 GMP introduces a major shift in China’s regulatory expectations, making early preparation essential for manufacturers targeting the China market. Phased system updates and coordinated planning with Chinese facilities or contract manufacturers will be key, as the new requirements affect both in-country operations and overseas quality systems supporting China registrations.

Cisema supports overseas manufacturers in interpreting the changes, assessing compliance gaps and implementing China-ready quality systems. With on-the-ground expertise, we guide organizations through each step of NMPA compliance for medical devices.

For assistance with transition planning for the new “Good Manufacturing Practice for Medical Devices,” or a gap analysis to check readiness, contact Cisema’s regulatory specialists today.

Comparison Table: 2014 GMP vs. 2025 GMP for Medical Devices

The table below summarizes how the updated regulation changes the expectations for medical device manufacturers preparing for China market compliance.

Topic2014 GMPNew 2025 GMP (Effective 1 Nov 2026)Regulatory structureFewer chapters with limited prescriptive detail.Expanded to 15 chapters and 132 articles with detailed requirements.Lifecycle coverageFocused mainly on production quality control.Full lifecycle coverage, including outsourced R&D, contract manufacturing, external processing, and entrusted testing.Quality assuranceGeneral QMS framework without a dedicated QA chapter.New QA chapter (Articles 7–13) with structured QA systems, formal change control, and lifecycle risk management.Personnel requirementsBasic competency expectations.Defined education and experience thresholds; key roles must be full-time; production and quality leadership must remain separate.Facility and environmental controlBroad cleanroom and layout guidance.Detailed environmental parameters, defined pressure differentials, access restrictions, and requirements for IT system suitability.Equipment and instrumentsCalibration and maintenance required.Full equipment lifecycle documentation, clear status identification, and mandatory re-qualification after modifications or major repairs.Document and data managementElectronic records permitted but not specified.Electronic records and signatures formally recognized; audit trails, access control, and data integrity requirements defined.Design and developmentLimited design control provisions.Structured design controls, strengthened design transfer, and explicit oversight of outsourced development.Supplier and procurement managementBasic supplier oversight expectations.Risk-based supplier classification, mandatory quality agreements, change notifications, and risk-driven on-site audits.Contract manufacturingResponsibilities sometimes unclear.Clear role definitions, required quality agreements, two-way oversight, and strict separation of production vs. market release.Compliance thresholdLess prescriptiveHigher expectations requiring system upgrades, enhanced documentation, and strengthened supply chain control.

Further Information

• Learn more about Cisema’s support for China NMPA medical device registration

References

• Consult the full text of the NMPA’s official release “Announcement on the Issuance of Good Manufacturing Practices for Medical Devices (No. 107 of 2025)” in Simplified Chinese:
  NMPA – Good Manufacturing Practices for Medical Devices (No. 107 of 2025)
• Review the Center for Food and Drug Inspection’s (CFDI)detailed before-and-after comparison of GMP requirements, issued to support industry understanding of the revisions:
  CFDI – Comparison of revised Good Manufacturing Practices for Medical Devices