Policy Update: Shanghai Introduces New Measures to Optimize Temporary Import of Clinically Urgent Medical Devices, Assisting Foreign Enterprises in Accelerating Market Access in China - Regulatory News - Medical Devices

On October 16, 2025, the Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs jointly issued the Shanghai Pilot Work Plan for Service Guidance on Temporary Import of Clinically Urgent Drugs and Medical Devices. This new plan aims to streamline the temporary import process for clinically urgent drugs and medical devices in Shanghai, helping patients gain faster access to innovative medical products.

As a Contract Research Organization (CRO) specializing in medical device regulatory compliance services, CIRS Group has summarized the key policy highlights on temporary imports of medical devices. This guidance is designed for foreign medical device manufacturers to help them understand the new procedures, capitalize on policy benefits, and accelerate market access for their products in China.

I. Who can apply?

Applicant: Medical institutions in Shanghai possessing the appropriate diagnostic and treatment qualifications.
Target Devices: Medical devices that are clinically urgent and have not yet received market approval in China.

II. How do you apply?

1. Inquiry and Preparation: Medical institutions can inquire and prepare application materials by contacting the Shanghai Municipal Medical Products Administration (Tel: 021-63269368) and the Shanghai Municipal Health Commission (Tel: 021-23117857). Application materials must be prepared according to the Management Requirements for the Use of Temporary Imported Clinically Urgent Medical Devices by Medical Institutions jointly issued by the National Medical Products Administration (NMPA) and the National Health Commission (NHC).

2. Submission of Application: Medical institutions must submit the formal application to the NMPA, simultaneously copying the application materials to the Shanghai Municipal Health Commission and the Shanghai Municipal Medical Products Administration.

3. Assessment and Guidance: Guided by the NMPA, the Shanghai Municipal Medical Products Administration conducts preliminary assessment and guidance regarding the medical institution's management capabilities, the clinical urgency of the device, and the reasonableness of the requested quantity, subsequently providing an assessment opinion. The Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs have established an information-sharing mechanism to promptly communicate the NMPA's approval status for clinically urgent devices, accelerating the import and customs clearance process.

III. Streamlined Assessment for Non-First-Time Imports

For medical devices that have already received temporary import approval, when continued use or increased quantities are required:

(1) If the same medical institution reapplies for the same device model, the initial assessment opinion can be reused, with only a necessary assessment of the quantity conducted.

(2) If a different medical institution applies for the same device model, the focus shifts to assessing the new institution's management capabilities and the required quantity, without re-evaluating the clinical urgency of the device model.

IV. Significantly Simplified Customs Clearance Process

After a medical institution purchases the corresponding medical device through a medical device distributor, the distributor can apply for an import customs declaration directly using the NMPA's approval document. Shanghai Customs will assist in expediting the customs clearance procedures, and no customs inspection is required, thereby significantly improving import efficiency.

V. Clear Use Management and Responsibilities

Medical institutions, as the users of temporarily imported devices, must assume the following management responsibilities:

Develop clinical technical specifications defining the device's intended clinical use, patient population, using departments, and authorized physicians.
Formulate comprehensive safety precautions and risk monitoring and contingency plans.
Establish a sound quality management system and ensure appropriate storage conditions.
Perform adequate patient informed consent and maintain long-term records of medical records and other relevant data related to device use.
Report device usage annually to the Shanghai Municipal Health Commission, copying the report to the Shanghai Municipal Medical Products Administration.
Conduct adverse event monitoring. In the event of serious adverse reactions/incidents directly related to the device, or upon discovery of quality or safety risks, immediately cease use and report to the Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs.

Conclusion

Shanghai's newly introduced policy on the temporary import of clinically urgent medical devices reflects China's ongoing efforts to optimize market access pathways for medical devices and enhance patient access to necessary treatments. This represents a significant policy opportunity for foreign innovative medical device companies aiming to enter the Chinese market at an earlier stage.

If you have products intended for the Chinese market via the temporary import pathway, or need further information on registration, clinical trials, and related compliance services, please feel free to contact us via service@cirs-group.com..

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