NMPA Overseas Inspection Escalation: Compliance of Overseas Medical Device Enterprises Cannot Be Delayed

On March 2, 2026, the Center for Food and Drug Inspection (CFDI) of China's National Medical Products Administration (NMPA) held a communication meeting for enterprises subject to overseas inspections of imported medical devices. During the meeting, 33 overseas medical device manufacturers were included in the 2026 overseas inspection plan. This signals a further tightening of supervision over imported medical devices by the NMPA, following the strengthened overseas system inspections for medical device enterprises in 2025, marking a regulatory trend towards normalized and full-coverage overseas inspections.

I. Trends in Overseas Inspection Policies

The "Provisions for the Overseas Inspection of Pharmaceutical and Medical Device Products" clearly stipulate that the CFDI organizes and implements overseas inspections, covering overseas R&D and production practices for both pre-market and post-market medical devices. The inspection results directly impact the import license and market access of medical devices. The newly revised "Good Manufacturing Practice for Medical Devices" (2025) will come into effect on November 1, 2026. This new version adds chapters on quality assurance, validation and verification, and contract manufacturing. Overseas inspections will focus on core elements such as data authenticity, whole lifecycle traceability, risk management, and contract manufacturing control.

According to NMPA policy, overseas inspections of medical devices in 2026 will primarily be unannounced (for-cause) inspections, supplemented by remote inspections and documentary reviews. The focus will be on high-risk overseas medical devices, including: sterile and implantable devices (e.g., coronary stents, orthopedic implants), centralized procurement winning devices, large medical equipment (e.g., MRI, CT, ultrasound imaging equipment), medical aesthetic devices, and in vitro diagnostic reagents.

II. Core Content of Overseas Inspections

Overseas inspections primarily target companies with serious adverse event reports, large multinational medical device groups, and overseas manufacturers that have recently obtained registration certificates or frequently make changes.

Based on the requirements of the new version of the "Good Manufacturing Practice for Medical Devices" (New GMP), the key focus areas of overseas inspections include: authenticity and traceability of data, standardization of QMS operation, risk management, and control over contract manufacturing and the supply chain. During the inspection, overseas companies are required to submit the "Basic Information Form for the Overseas Inspected Product" and provide complete production, testing, and quality control records.

III. Typical Cases of Overseas Inspections

1. Remote Inspection of a Korean Company's Allogeneic Bone Repair Material

A Korean biotechnology company's allogeneic bone repair material (ExFuse Bone Graft; Registration No.: 国械注进 20193130564) was subjected to an NMPA remote inspection. The inspection revealed non-compliance with the requirements of China's "Good Manufacturing Practice for Medical Devices" and its appendix for implantable medical devices. Consequently, the NMPA suspended its import, distribution, and use in China on May 11, 2023.
After multiple rounds of audits, rectifications, and mock inspections conducted by the CIRS Group QMS team, the Korean company successfully passed the NMPA's document review and on-site inspection. Its import, distribution, and use of the allogeneic bone repair material in China were officially restored effective April 11, 2025.

2. On-Site Inspection of Korean Company's ePTFE Facial Implant

Search Medical Co., Ltd., a Korean company, manufactured an expanded polytetrafluoroethylene (ePTFE) facial implant (Registration No.: 国械注进 20243130468) which was subjected to an NMPA on-site inspection. The inspection identified serious deficiencies in the quality management system related to organization and personnel management, equipment management, document management, and design and development. These did not meet the requirements of China's "Good Manufacturing Practice for Medical Devices." The NMPA suspended its import, distribution, and use in China on September 30, 2024.

3. Remote Inspection of Italian Company's Artificial Knee Joint System

SAMO S.p.A., an Italian company, manufactured an artificial knee joint system (Trekking knee system; Registration No.: 国械注进20173130169) which was subjected to an NMPA remote inspection. The NMPA found issues including failure to effectively identify requirements of Chinese regulations and errors in the parameter labeling of product technical specifications. This did not meet the requirements of China's "Good Manufacturing Practice for Medical Devices" and its appendix for implantable medical devices. The NMPA suspended its import, distribution, and use in China on July 18, 2024.

IV. CIRS Group's Strategy for Responding to Overseas Inspections

Currently, overseas regulatory inspections for medical devices in China have entered a phase of normalization. Overseas medical device enterprises should pay attention to Chinese regulatory requirements, ensure the quality and safety of imported medical devices, and deeply integrate China GMP requirements into their global quality management systems. Drawing on years of experience in on-site audits and rectification guidance for large overseas medical groups, the CIRS Group QMS team recommends that overseas medical device companies take the following actions:

• Compliance Self-Audit: Overseas medical device manufacturers should internally audit their quality management systems according to the new version of China GMP, make necessary rectifications in advance, and conduct reviews.
• Cooperate with Inspections: Respond promptly upon receiving an NMPA inspection notice, and provide authentic, complete, and traceable records.
• Proactive Rectification: Immediately rectify any deficiencies found during the inspection, submit a rectification report, and strive to pass the re-inspection.

Targeting the risks faced by overseas medical device enterprises regarding NMPA compliance review, CIRS Group has developed a comprehensive solution. We can assist overseas medical device enterprises in proactively conducting quality management system self-audits, on-site reviews, and rectification work, thereby preventing the suspension of import and use of medical device products in China due to non-compliance with overseas inspection requirements.

If you are interested in the above content and wish to learn more; Or if you have any requirements for QMS support services, please feel free to contact the CIRS Medical Devices Department at any time. Our contact information is as follows:

CIRS Medical Device BU E-mail Address: md@cirs-group.com