Regulatory Update: NMPA Releases Four Updated GMP Inspection Guidelines for Medical Device Manufacturers
- Date
- October 28, 2026
- Category
Other Regulations
- Description
On 28 October 2026, the National Medical Products Administration (NMPA) announced the publication of four revised inspection guidelines supporting the implementation of the revised Medical Device Good Manufacturing Practice (GMP), which will come into force on 1 November 2026.
The newly issued guidance documents cover the following product categories:
- Medical Device GMP Inspection Guideline for Sterile Medical Devices.
- Medical Device GMP Inspection Guideline for Implantable Medical Devices.
- Medical Device GMP Inspection Guideline for In Vitro Diagnostic (IVD) Reagents.
- Medical Device GMP Inspection Guideline for Custom-made Dentures.
The revised guidelines were developed to align inspection practices with the updated GMP requirements and to provide a consistent framework for regulatory inspections. Beginning 1 November 2026, the NMPA will apply these new guidelines when conducting manufacturing licence inspections and post-market surveillance inspections for the applicable product categories.
For manufacturers marketing medical devices in China, these updated guidelines provide important insight into NMPA's inspection priorities. Manufacturers are therefore encouraged to review the updated guidance and perform a gap assessment, where appropriate, to identify any compliance gaps and ensure ongoing regulatory readiness.
NSF can support you in evaluating the impact of the revised requirements, identifying compliance gaps, and preparing for future inspections and regulatory activities in China.