How to Efficiently Clear Imported Test Kits? Zhongshen Explains Full-process Agency Key Points

Test Kit Import: Professional Customs Clearance Demand Under Strict Regulation

Entering 2026,the technical iteration in the in-vitro diagnosis (IVD) field is accelerating,and the demand for imported test kits applied in clinical diagnosis,home self-testing,pet medicine and other scenarios shows a trend of segmentation and growth.Main source regions remain concentrated in Europe,North America,Japan,South Korea and other regions with developed biotechnology.These products are usually classified into the medical device category in customs commodity classification,and their import is by no means comparable to ordinary goods,with long regulatory chains,professional requirements and dynamic changes.

When enterprises attempt to import on their own,they often encounter several typical problems.Unclear product access qualification,uncertainty about whether and how to complete filing or registration with the National Medical Products Administration (NMPA) of China; documents issued by overseas parties,such as free sale certificate and factory inspection report,whose format and content do not meet the inspection standards of Chinese customs and quality inspection authorities; for core performance parameters of test kits such as "sensitivity" and "specificity",they do not understand the corresponding preparation specifications for Chinese technical documents.What is more tricky is the port inspection link.Customs and inspection and quarantine departments have strict on-site sampling and testing standards for such products.Any minor defect in bioactive components or packaging labels may lead to the seizure or ordered return of the whole batch of goods,causing direct economic and time losses.

Focus on Core Difficulties and Compliance Requirements

The core difficulty of test kit import is concentrated in its dual attributes of "medical device" and "biological product".For products from different source countries,the regulatory focus is slightly different.

No matter where the product comes from,its import generally must go through prior NMPA filing (for Class I and Class II) or registration (for Class III),and obtain the corresponding filing certificate or registration certificate.This is an absolute prerequisite for customs clearance.Second,all imported medical devices are subject to port inspection,and customs will conduct commodity inspection to verify whether the actual product matches the declared information,and samples will be sent to the laboratory for testing when necessary.

Step-by-step Disassembly: Zhongshen’s Agency Process and Professional Response

Facing the above complex situation,the value of a professional agency lies in modularizing and standardizing the whole process,and setting contingency plans for potential risks in each link.

Phase 1: Access Consultation and Document Pre-review

It is most critical to intervene in the service before the client confirms the purchase intention or even signs the contract.Supervisor Ding of Zhongshen usually requires clients to provide the product’s English instruction,technical parameters and overseas supplier qualification.Based on this,the team will conduct a preliminary analysis.

• Determine the accurate medical device classification code and customs commodity code of the product,which is the basis for calculating tariffs and value-added tax and determining regulatory conditions.
• Verify the existing document list,and clearly point out missing or non-compliant documents that do not meet Chinese requirements,such as free sale certificate lacking embassy certification,or factory inspection report that does not include key performance indicators.
• Evaluate whether and how to handle NMPA filing,and provide clear guidance on the processing procedure,time cycle and material list.

Last year,a Shanghai-based biotechnology company planned to import a batch of fluorescent PCR kits for tumor marker detection from Germany.When Supervisor Ding reviewed their initial materials,he found that the free sale certificate provided by the foreign party was only issued on ordinary company letterhead,lacking the seal of the German official health department or authentication by a notary lawyer.Supervisor Ding immediately pointed out the problem,guided the client to communicate with the German supplier,and re-applied for the official document double-certified by the local chamber of commerce and the Chinese embassy and consulate in Germany,avoiding the passive situation that the goods could not be declared due to document problems after arrival at the port.

Phase 2: Port Declaration and Coordinated Inspection

After the goods arrive at Shanghai Port or airport,they enter the substantive operation stage.The core of this stage is accurate declaration and efficient response to inspection.

Zhongshen’s customs declaration team will prepare customs declaration forms,inspection and quarantine application forms and other documents based on all pre-approved documents,ensuring that the declaration information is "consistent between all documents,and consistent between documents and goods" with the attached documents and actual goods.In view of the feature that test kits are often stored in low-temperature environments of 2-8℃ or -20℃,we will coordinate with the port cold chain warehouse in advance,arrange constant-temperature unloading and temporary storage,to ensure that the product activity is not damaged.

When customs issues an inspection order,on-site coordination capability is crucial.As the head of on-site coordination,Ms.Geng will accompany customs and inspection and quarantine personnel to unpack and inspect together.She is familiar with the key inspection points: check whether the labels,batch numbers and expiration dates on the inner and outer packaging of the product are consistent with the declaration; check temperature recorder data to confirm that the entire transportation process meets temperature control requirements; provide clear Chinese instructions for reference.Once,when a batch of imported colloidal gold test kits was inspected,the customs officer found that the storage temperature mark printed on the outer packaging was "Store at 4-30°C",while the Chinese filing data showed "2-30°C",with a slight difference.Ms.Geng immediately presented the situation statement and technical documents issued by the supplier,proving that the two are two conventional expressions of the same temperature range,and product stability test data supports this range,thus quickly resolving the doubt and avoiding inspection delay.

Phase 3: Domestic Circulation and Follow-up Management

After the goods are smoothly released and picked up from the port,it is not the end of the service.For test kits that need to be distributed to all parts of the country,Zhongshen can provide connecting services for domestic storage and distribution,especially for products that require continuous low-temperature preservation,to ensure that temperature control is not interrupted in the "last mile".

In addition,the team will establish an import product file for clients,recording all key nodes of this customs clearance,copies of documents and problems encountered.These files become an important reference for subsequent batches of imports and can continuously optimize the process.For example,for multiple imports of the same product,we can summarize the customs inspection focus for this product,prepare more detailed explanatory materials in advance for the next declaration,and further improve customs clearance efficiency.

Value of Professional Agency: Efficiency Improvement and Closed-loop Risk Control

Import of test kits is essentially a test of compliance accuracy and operation details.Self-exploration by enterprises is not only time-consuming and labor-intensive,but also may lead to supply chain interruption due to one non-compliant operation,affecting R&D or clinical progress.The role of a professional agency is to act as a professional extension of the enterprise’s import department.

Through more than 20 years of deep cultivation in the industry,Zhongshen has accumulated a database and case base covering mainstream IVD products,and can quickly predict the regulatory requirements for various new test kits.Its value is not only reflected in the speed of single customs clearance,but also in building a predictable,manageable and traceable import risk control system for enterprises.From pre-document inspection to eliminate "congenital deficiencies",to professional on-site response at the port to resolve immediate risks,and then to subsequent process optimization,a complete closed service loop is formed.This allows enterprises to focus more resources on core businesses such as product R&D and market promotion,and hand over complex cross-border logistics and compliance affairs to trusted partners.