What To Check Before Importing Dialysis Products From China

Why Choose to Source Dialysis Products from China

China has become a major global option for import dialysis products, mainly due to three core advantages:

• More Controllable Production Inputs

Chinese manufacturers reduce the average production cost of common dialysis consumables (such as dialyzers, AV fistula needles, and blood tubing sets) through large-scale manufacturing. A mature industry supply chain also lowers expenses related to mold development, labor allocation, and packaging procedures.

• Verifiable Quality and Supply Capacity

Most major Chinese manufacturers have long supplied dialysis equipment and consumable parts to medical markets in Europe and the Middle East. Customers can source polysulfone dialyzers, high-efficiency dialysis equipment, matched filtration systems, and a complete set of consumables required for treatment.

• Continuous Technical Improvement

Manufacturers maintain ongoing technical upgrades in key fields, including dialysis membrane performance optimization, sterilization process enhancements, and production automation. These investments support long-term product stability.

Mandatory Certifications and Documents Before Importing

When purchasing through a medical device import guide, buyers must ensure that the supplier provides three categories of essential documentation:

Basic Product Compliance Certificates

The European market requires CE marking (most dialysis equipment falls into Class IIa/IIb), and manufacturers must hold medical-device-specific ISO quality management certifications. Each production batch must include a COA test report specifying safety and sterility information.

Market Access Documentation

Middle Eastern and African imports require an FSC (Free Sales Certificate). Chinese domestic compliance materials must include two items: the provincial authority–issued manufacturing license and the registration/record certificate for the specific product model. Modern procurement also requires attention to UDI coding systems and technical files—primarily used for risk traceability and regulatory inspections.

Customs Clearance Documents

Customs procedures require standard documents: packing list describing specifications and quantities, commercial invoice with declared value, and customs declaration form with correct HS codes. Due to medical device characteristics, sterilization process records (including EO or irradiation sterilization proof), laboratory test results, and a manufacturer’s declaration of conformity must also be provided.

Import Regulations by Region (EU / Middle East / Africa)

Different medical markets impose specific regulatory requirements for dialysis product imports. Preparation must be aligned with the target region:

European Union Market

• Products must comply with EU Medical Device Regulations.

• CE certification is mandatory for market entry.

• Importers must undertake three responsibilities after products enter the market: establishing a user complaint tracking mechanism, implementing post-market surveillance, and maintaining complete product traceability records.

Middle East Region

• Saudi Arabia requires SFDA approval documents.

• Qatar requires QCC certification.

• The UAE applies the MOHAP registration system.

• Beyond regional registration, two additional documents are typically required: a notarized copy of the Free Sales Certificate (FSC) and an Arabic-language translation version.

African Market

• Countries such as Kenya, Nigeria, and Ghana enforce import licensing systems and mandatory pre-shipment inspections.

• Regulations vary by region: some countries accept EU CE certification as a substitute for local registration (e.g., Egypt, Morocco), while others such as Algeria require independent filing with local regulatory authorities.

→This is our CE/FDA certified hemodialysis products available to global distributors.

Supplier Verification Checklist

Before confirming cooperation with a supplier in the China dialysis export market, verification must include three categories:

Basic Qualification Review

• Check two original certificates: business license + medical device export record certificate.

• Verify the manufacturer’s registration number via China’s official regulatory platforms (noted domestically as NMPA filing).

• Key reminder: manufacturing experience for dialysis-related products is recommended to be ≥ 3 years.

Product Compliance Documentation

• Obtain the product’s Chinese domestic registration approval (not export-only documents).

• Request three current standard certificates:

▪ISO quality management system certification

▪Dialyzer blood-filtration performance test report

▪Pressure-resistance records for bloodline products

Manufacturing System Validation

• Conduct three types of on-site audits (video audit accepted):

▪Dialyzer assembly production line

▪EO/irradiation sterilization facility

▪Class-10000 cleanroom environment

• Review quality logs to confirm three capabilities:

▪Raw material batch sampling execution

▪Finished-product defect rate statistics

▪Product traceability marking coverage

• Confirm in advance whether the supplier supports OEM/branding customization services.

Transportation, Customs, and After-Sales Support

In the transportation process, it is essential to confirm applicable trade terms:

- FOB indicates the supplier covers costs up to the port of loading;

- CIF includes freight and insurance to the destination port;

- DDP requires the supplier to handle customs clearance and tax payment in the destination country (the specific choice must align with your national regulations for import dialysis products).

Before shipment, verify two types of packaging strength: the protective compression layer for dialyzer housings and the shock-absorbing fillers for infusion-set connectors. Most consumables do not require temperature-controlled shipping, but moisture-proof sealing must remain intact.

Customs declaration requires three key elements: dialyzers are declared under HS code 9018, A.V. fistula needles under 90183190, and blood tubing sets commonly under 90183900. All EO sterilization records must be linked to the customs declaration number.

After-sales support includes two major aspects: consumables (dialyzers and tubing sets) must maintain a complete traceability system; durable items (such as water-treatment equipment and reprocessors) must include a three-year warranty and video installation guidance. Technical documentation must include bilingual operation manuals and troubleshooting code guides.

Import Pitfalls to Avoid

► Incomplete Documentation

Missing the EU CE Declaration of Conformity may result in detainment at European ports; absence of sterilization validation reports for each batch of dialyzers may trigger returns in Middle Eastern regions; missing NMPA factory filing documents forms a major clearance barrier in Asia-Pacific markets.

► Fake Manufacturers

Agents posing as manufacturers must be screened through dual evidence: the China NMPA medical device manufacturing license number + real factory operation videos. Be cautious of suppliers unable to provide dynamic footage of dialyzer-membrane production lines.

► Regional Regulatory Issues

The same product may face multiple regulatory layers across jurisdictions: Africa often requires an additional FSC, Gulf countries mandate Arabic-language labeling, and EU regulations increasingly require clinical evaluation report reviews. Regulation updates must be monitored monthly via local import agents.

► Insufficient Production Capacity

Overlooking true production capacity leads to continuous supply delays (dialyzer-membrane capacity shortage is a primary factor), sudden quality fluctuations (overloaded factories increase defect rates in dialysate filters), and long-term risks such as outsourced technical subcontracting.

► Over-emphasis on Price

Lowest-price sourcing creates a three-stage risk chain: using low-flux membranes reduces clearance rate; shortened EO de-aeration periods cause residual over-limits; reduced bioburden testing frequency increases microbial contamination risk.

CN MEDITECH Dialysis Product Portfolio for Global Export

Global Supply Capability

Selecting a global supplier for China dialysis export requires validation of three capabilities:

possession of multi-category CE certifications ensuring that dialyzers, tubing sets, catheters, and other consumables meet market access requirements;

a mature export-operation system prioritizing supply of essential components during capacity fluctuation periods;

core patented moisture-proof packaging technology for special categories such as dialysate powder.

Fast Response Mechanism

Three strategic cooperation channels are now available:

technical support offering modular dialysis product data packages (including sample-tested parameters and international registration-file templates);

regulatory support for real-time response to clearance irregularities in the destination country;

business support with customizable dialysis consumable combination packages—from standard bloodline sets to RO water-treatment accessories.

Immediate action recommended:

Send your requirements to meditech@cn-meditech.com to receive a solution within three working days.