What Compliance Procedures Are Required for Imported Rehabilitation Equipment with Consumables Agency? Shanghai Port Experts Break Down

Core Compliance Nodes for Imported Rehabilitation Equipment with Consumables Agency (Shanghai Port Practical Operation)

1.Medical Device Filing and UDI Compliance (2026 Mandatory Requirement)

In 2026,China implements mandatory traceability requirements for UDI (Unique Device Identification) of Class III medical devices.For rehabilitation equipment with consumables,UDI codes for both the main equipment body and supporting consumables need to be marked simultaneously,which is the core regulatory change this year.Our company handled a case last year: a client imported a German brand of rehabilitation training equipment,whose matching disposable electrode pads were not marked with China-approved UDI codes.This caused 3 days of inspection delay at Shanghai Airport Port,resulting in demurrage fees of RMB 28,000.We later assisted the client in completing supplementary UDI filing,and the goods were successfully released.

• Check the scope of the Medical Device Registration Certificate issued by NMPA (National Medical Products Administration) in advance,to ensure that the consumables attached to the equipment are listed in the "Supporting Consumables" column of the registration certificate,so as to avoid order rejection due to over-scope declaration;
• UDI codes must comply with GS1 standards,and be uploaded to the China National Medical Device Unique Identification Database.UDI assignment certification shall be submitted to customs during customs clearance;
• Foreign-language operation manuals shall be translated into Chinese texts that meet the provisions of *Regulations on the Administration of Medical Device Instructions and Labels*,all technical parameters shall be consistent with the registration certificate,and no vague expressions are allowed.

2.Key Details of Price Verification and Commodity Inspection Pre-review

The price verification logic for rehabilitation equipment with consumables at Shanghai Port adopts the overall valuation of "equipment + consumables",but the respective value of the core equipment and supporting consumables shall be distinguished,to prevent customs from judging that the total value is under-declared.In 2026,customs launches a new price verification system for electromechanical equipment,which implements stricter valuation on the second-hand status and service life of imported equipment.Earlier this year,our company assisted a client in handling a US-imported rehabilitation training bed.Due to the failure to provide the equipment condition report issued by a third-party China Inspection body,the price verification cycle was 5 days longer than expected,resulting in additional loss of document exchange fees.

3.Import License and Pre-positioned Risk Warning

In 2026,some rehabilitation equipment manufactured in the EU is subject to anti-dumping duties,for which the "Automatic Import License" shall be processed in advance,and the country of origin and production batch of the products shall be marked on the Certificate of Origin.Last year,our company handled an imported rehabilitation equipment from Italy.As the model of supporting consumables was not marked on the license,customs required the declaration to be returned for re-submission.Later,we coordinated with the Italian supplier via our global agency network to obtain a supplementary copy of the Certificate of Origin,thus avoiding delivery delay.In addition,note that the customs clearance efficiency of global ports will decrease during the 2026 Christmas season (December 20 to January 5).Completing document review 15 days in advance can avoid demurrage risks.

• Pay close attention to the *Announcement on Adjustment of Imported Medical Device Regulation* issued by customs in 2026,and focus on the change of regulatory entries involving rehabilitation equipment;
• Exchange loss risk: Give priority to RMB settlement,to avoid exchange rate fluctuations caused by non-USD foreign currency settlement;
• Hidden fees: Confirm the details of document exchange fee and inspection fee in advance,to prevent the agency company from charging additional unjustified fees such as "express handling fee".

Cross-location Declaration Coordination Advantages of Shanghai Port (Core Competence)

Our company is based in Shanghai,with agency qualifications for nationwide port linkage,which can realize the operation mode of "pre-review at one port and customs clearance at another port".In 2026,the medical device supervision system of all ports across China is connected to the network,and the documents for cross-location declaration can be directly synchronized to the destination port,increasing customs clearance efficiency by more than 40%.Earlier this year,our company assisted a northern client to import rehabilitation equipment from South Korea.We completed customs clearance in Shanghai via cross-location declaration,which saved 6 days compared with declaration at Tianjin Port,and avoided additional costs caused by cold chain transportation of the equipment.

To address blind spots in global trade compliance,our company has agency outlets in 18 major global trading countries,which can verify the market access qualification of the destination country in advance,such as the EU CE MDR Regulation and US FDA certification,to ensure two-way compliance for imported rehabilitation equipment with consumables.In 2026,the EU has stricter supervision on the consumables of rehabilitation equipment,requiring to provide environmental protection test reports for supporting consumables.Our company assisted the client in preparing the test report issued by a Spanish laboratory in advance,successfully passed the review of EU Certificate of Origin,and avoided the risk of tariff increase.

At the final stage of customs clearance,our company will arrange dedicated staff to follow up the whole process,to ensure smooth delivery of the equipment and consumables,and avoid situations of missed delivery or wrong delivery.Last year,for a client’s imported rehabilitation equipment with consumables,we coordinated the dedicated warehouse space at Shanghai Port in advance.After inspection,the goods were directly transferred to the cold chain warehouse of the hospital,saving the time for secondary transportation.