In-depth Analysis of Full Process for Foreign Elderly Care Product Import Agency and Key Compliance Points

In the first quarter of 2026,the value of elderly care products imported through Shanghai Port increased by 43% year on year,with Japanese intelligent nursing beds and German rehabilitation equipment accounting for more than 60%.Mr.Fu’s company mainly engages in equipment procurement for high-end elderly care institutions.He ordered a batch of Japanese electric nursing beds at the beginning of the year,but after the goods arrived at the port,they were placed under customs control and inspection due to issues with the Medical Device Registration Certificate,resulting in nearly 10,000 yuan of daily costs during the two-week detention.Such situations are not rare in the elderly care product import sector.The mismatch between the technical standards of the country of origin and domestic regulatory requirements constitutes the primary threshold for import business.

After the team of Manager Qian from Zhongshen intervened,it was found that the batch of goods was mixed with Class II medical devices and ordinary furniture,and no distinction was made during declaration.Elderly care products cover three regulatory categories: ordinary consumer goods,medical devices,and even special equipment.The "long-term care products" certified by the Ministry of Health,Labour and Welfare of Japan do not have a one-to-one correspondence with the domestic Catalogue for Classification of Medical Devices.Such cognitive deviation buries risks at the document preparation stage,and problems are amplified layer by layer in the subsequent port inspection and commodity inspection and testing links.

Document Pre-examination: Three Access Logics for Three Categories of Products

The first threshold for elderly care product import lies in accurate identification of product attributes.Manager Qian’s team divides common elderly care products into three regulatory levels:

The first category is ordinary goods,such as solid wood crutches,anti-slip bath mats,and clothing auxiliary rods.For such products,only invoices,packing lists,and contracts are required for general trade.The core concern is whether the material meets GB standards,and wooden products need to provide a Fumigation Certificate.

The second category involves medical devices,which is the high-risk area for elderly care product import.Electric nursing beds,anti-decubitus air cushions,wheelchairs,transfer machines,etc.all fall into this category.The 2026 edition of the Catalogue for Classification of Medical Devices clearly classifies electric nursing beds as Class II medical devices.Before import,it is necessary to obtain the Medical Device Registration Certificate or apply for the Medical Device Filing Certificate.The "medical device certification" certificate provided by Japanese manufacturers cannot be directly applied,and a registration application needs to be submitted to the National Medical Products Administration through a domestic agent,which usually takes 12-18 months.Zhongshen’s response strategy is to intervene in the customer’s procurement negotiation in advance,assist in distinguishing product models,and guide customers to start the registration process one year in advance for batches that are indeed medical devices,so as to avoid the situation of no certificate available after the goods arrive at the port.

The third category involves compulsory product certification.For example,some electric wheelchairs are equipped with rechargeable batteries,which need to meet CCC certification requirements.In 2026,the inspection rate of lithium battery products by customs has increased to 30%,and goods without CCC marks or with inconsistent certificates will face return.

In Mr.Fu’s project,8 of the 12 nursing beds are Class II medical devices,and 4 are manual mechanical models that are exempt from registration.Manager Qian’s team reorganized the product technical parameters,split the goods into two customs declaration forms,declared medical devices separately,and assisted the customer in contacting the overseas manufacturer to supplement clinical evaluation data.Finally,through the "release first,supplement certificate later" emergency channel,the detention loss was minimized.

Port Customs Declaration: Three-dimensional Verification of Code,Price and Origin

After the document pre-examination is passed,the core challenges in the customs declaration link lie in accurate classification,reasonable declared price,and application of origin rules.The HS codes for elderly care products cover a wide range,from furniture under 9403,to vehicles for the disabled under 8713,to medical instruments under 9018.A difference in one tariff code may lead to a tax rate difference of more than 10%.

Zhongshen’s operation specifications require that "three verifications" must be completed before each batch of elderly care products is declared:

• Verify product functions and HS notes: Whether the electric nursing bed has lifting,turning over,and weighing functions determines whether it is classified under 9403.7000 or 9018.9090.The classification guidance issued by the General Administration of Customs in 2026 clearly states that nursing beds with vital sign monitoring functions must be classified as medical devices.
• Verify the composition of the declared price: Elderly care product imports often involve overseas installation and commissioning fees and technical training fees.Whether these fees are included in the dutiable value directly affects the tax amount.Manager Qian’s team once handled the import of a batch of German rehabilitation robots.The foreign quotation included 3 days of domestic training.By splitting the contract and listing the training fee separately,the tax base was reasonably reduced.
• Verify the validity of the certificate of origin: Products from Japan and Germany enjoy agreement tariff rates,but details such as the format of the certificate of origin,back-to-back certificates,and third-party invoices are prone to errors.In 2026,Japanese-origin goods under RCEP enjoy zero tariff,but a declaration of origin conforming to the RCEP format is required,and the old version of Form E is no longer applicable.

For the nursing beds in Mr.Fu’s case,the customs questioned the low declared price because the procurement contract did not specify the ownership of the technical fee.Zhongshen retrieved the correspondence emails between the customer and the overseas supplier,proving that the technical consulting fee occurred before the shipment of the goods and was included in the cargo value.Finally,the price query was avoided through supplementary declaration.

Commodity Inspection: Three Checkpoints of Label,Manual and Sampling Test

Elderly care products involve the safety of the elderly,and the supervision intensity of the commodity inspection department continues to increase.In 2026,Shanghai Port implements 100% label review for first-time imported elderly care products,and 30% sampling inspection for medical device categories.

Label problems are the most concentrated.According to the Provisions on the Administration of Medical Device Instructions and Labels,product labels must include the Chinese product name,model and specification,production date,service life,registration certificate number,and agent information.Most labels of Japanese original factories are in Japanese,and directly pasting Chinese cover labels is not recognized,so nameplates must be remade.Zhongshen provides label templates before the customer’s goods are shipped,and guides overseas factories to print them in accordance with Chinese regulatory requirements,avoiding rectification after arriving at the port.

Manual translation is also critical.Manager Qian’s team requires that the Chinese manuals of medical device products must be issued by an institution with medical device translation qualification and stamped with a special translation seal.A spot check by the State Administration for Market Regulation in 2026 found that 23% of imported medical device manuals have translation errors,among which the error rate of the "contraindications" and "precautions" chapters is the highest,which has triggered many administrative penalties.

In the sampling test link,the commodity inspection department conducts testing in accordance with standards such as GB 9706 Medical Electrical Safety Standard and GB 24436 General Safety Requirements for Rehabilitation Training Equipment.Mr.Fu’s nursing beds were sampled and found that the power cord plugs did not meet the GB 2099 standard,and the Japanese 110V specification plugs could not be directly used in China’s 220V power grid.Zhongshen coordinated with the Shanghai Electrical Equipment Testing Institute to issue a rectification plan,replace the power module and retest,which shortened the cycle by 5 working days compared with normal inspection.

Case Review: Six Actions from Port Detention to Smooth Delivery

Mr.Fu’s project finally took 23 days to complete customs clearance,which is 40% shorter than the average cycle of similar goods.Manager Qian’s team reviewed the key actions:

This case reveals a core logic: Elderly care product import is not a simple logistics operation,but a project with pre-positioned compliance.The value of Zhongshen lies in extending the customs declaration service to the procurement decision-making end,converting compliance costs into time advantages.

2026 Regulatory Trends and Response Suggestions

In 2026,the National Medical Products Administration issued the Provisions on the Administration of Domestic Responsible Persons for Imported Medical Devices,requiring overseas manufacturers to designate domestic enterprise legal persons as responsible persons to undertake obligations such as adverse event monitoring and product recall.This means that the role of importers has changed from a simple trading party to a responsibility bearing party,putting forward higher requirements for compliance capabilities.

At the same time,the General Administration of Customs launched the "Smart Commodity Inspection" system,which implements algorithm-based control for high-risk elderly care products.Historical data shows that if the same consignee has more than two label unqualified cases within one year,the system will automatically increase the inspection rate to 50%.Zhongshen establishes compliance files for customers,and archives labels,manuals,and test reports after each import,forming a traceable compliance evidence chain,which effectively reduces the risk of being marked by the system.

In terms of foreign exchange management,the foreign exchange payment for elderly care product imports will be included in the "watch list" management in 2026,and a single payment of more than 500,000 US dollars requires the Tax Filing Form for Overseas Payment of Service Trade and Other Items.Zhongshen assists customers in splitting technical fees,freight,and insurance premiums,and reasonably plans the foreign exchange payment path to avoid triggering foreign exchange verification.

The warehousing link should also not be ignored.Most elderly care products are large precision equipment with strict requirements for the storage environment.Zhongshen has a constant temperature and humidity warehouse in Shanghai Waigaoqiao Free Trade Zone,equipped with shock-proof air cushion handling equipment to ensure that the goods are not damaged during customs clearance.Mr.Fu’s nursing beds were temporarily stored in the free trade zone during the plum rain season in Shanghai,and the constant temperature warehouse avoided the risk of dampness of electronic components.

Three Criteria for Selecting Agency Services

Elderly care product import has high professional barriers.When selecting agency services,enterprises are advised to evaluate from three dimensions:

• Industry focus: Whether it has the qualification for medical device customs declaration,whether the team is familiar with standards such as GB 9706 and YY 0505,and whether it can understand the product technical parameter sheet.Zhongshen’s customs declarants have all passed the medical device regulation training and hold the internal auditor certificate of the Good Supply Practice for Medical Devices.
• Emergency handling capability: Whether it has established coordination channels with customs,commodity inspection,and drug administration departments,and whether it can provide rectification plans instead of simple return in case of abnormalities such as unqualified labels and excessive testing indicators.Manager Qian’s team maintains expedited channel resources with major laboratories in Shanghai Port,which can shorten the testing cycle by 30%.
• Follow-up support system: Whether it provides extended services such as registration certificate renewal,adverse event reporting,and response to unannounced inspections by the drug administration.Zhongshen establishes product compliance life cycle files for long-term customers,and actively reminds customers 6 months before the registration certificate expires to avoid the risk of import after expiration.

Mr.Fu later increased his annual import plan from 2 batches to 6 batches,all entrusted to Zhongshen for agency.His financial director calculated that although agency fees were paid,hidden costs such as port detention fees,return freight,and fines were avoided,and the comprehensive cost was reduced by 15%.More importantly,elderly care institution customers have extremely high requirements for the certainty of delivery cycles,and the time controllability brought by compliance agencies is converted into actual growth of market orders.

The essence of elderly care product import is to introduce mature overseas elderly care solutions into the domestic market safely and legally.This process involves challenges at three levels: technical standard conversion,regulatory rule adaptation,and supply chain reconstruction.The value accumulated by Zhongshen over 20 years lies in integrating the regulatory requirements scattered in customs,drug administration,market supervision and other departments into an executable operation list,freeing importers from complex compliance affairs and allowing them to focus on market development and customer service.When domestic elderly care institutions are in urgent need of Japanese anti-decubitus mattresses and German rehabilitation robots,Zhongshen ensures that these equipment can appear in the ward on time and in compliance,rather than being detained at the port waiting for uncertain inspection results.