China Releases Revised Medical Device GMP

China has taken a major step forward in strengthening its medical device regulatory framework. On 7 November 2025, the National Medical Products Administration (NMPA) officially released the revised Good Manufacturing Practice for Medical Devices (GMP), replacing the decade-old version issued in 2014. The new GMP will come into full effect on 1 November 2026, giving the industry one year to transition.

This revision marks a significant shift toward globalised standards, enhanced risk management, and modernised manufacturing controls all aligned with China’s ambition to raise the quality and competitiveness of its medtech sector.

Why this update matters

For manufacturers operating in or exporting to China, the revised GMP represents both an opportunity and an urgent compliance requirement. The updated framework reflects:

1. Full lifecycle risk management integration

NMPA now emphasises risk management across every stage of design, production, outsourcing, storage, and post-market performance. Manufacturers must strengthen internal processes to align with updated ISO and global best practices.

2. Clearer oversight for contract manufacturing & outsourcing

As outsourcing becomes more common, the new GMP clarifies responsibility boundaries. Both the contract giver and the contract manufacturer must comply with stricter controls, including documentation, quality agreements, and traceability.

3. Stronger controls for quality systems and validation

Manufacturers must enhance:

• Process validation

• Equipment calibration

• Environment control

• Record management

• Corrective and preventive actions (CAPA)

These updates aim to prevent quality lapses and ensure continuous compliance.

4. Adoption of digital & intelligent manufacturing trends

The revised GMP encourages digitalisation, including:

• Electronic records

• Automated quality control

• Real-time monitoring

• Improved traceability systems

These shifts align with China’s broader strategy to modernize its manufacturing ecosystem.

Key actions for manufacturers (2025–2026)

With the new GMP coming into effect on 1 November 2026, companies should begin their preparations now. Recommended steps include:

• Conduct a GMP gap assessment against the new requirements.

• Review outsourcing arrangements, including quality agreements and supplier monitoring.

• Strengthen documentation systems, especially for risk files, batch records, and CAPA.

• Enhance equipment qualification and process validation to meet the new standards.

• Train internal teams on updated requirements and compliance timelines.

• Digitalise quality management workflows where needed.

  
  

Early preparation will minimise disruptions and ensure a smooth transition into the 2026 compliance deadline.

Final Thoughts

China’s updated medical device GMP reflects its commitment to regulatory modernisation and international alignment. For manufacturers, this is a crucial time to proactively reassess operations, strengthen internal systems, and ensure readiness ahead of the 2026 deadline.

ARQon continues to monitor regional regulatory updates, helping companies navigate evolving requirements across Asia with confidence.

If you need assistance with GMP assessment, documentation, or China market entry strategy, our team is here to support.