In recent years, Chinas?Medical Devices?export scale to Germany has shown a trend of increasing year by year. According to relevant data statistics, the market share of Chinese medical device products in the German market is also gradually increasing, especially in the fields of low - value consumables, medical device accessories, and household medical devices.

With the development of technology and the intensification of the aging population trend, Germanys demand for medical devices will continue to increase. As one of the largest medical device producers in the world, China can provide a large amount of product supply to meet the needs of the German market. Therefore, a broad prospect for Chinas medical device exports to Germany can be foreseen. Now, lets take a look at the steps that medical devices need to go through from China to Germany.

I. Specific process

Preparation stage

• Qualification Application and Product Compliance: Enterprises need to go through export filing procedures and obtain medical device registration certificates, ensure that products meet Chinese and international standards, and establish a sound quality management system.
• Market Research: Deeply understand the demand, competition situation, policies and regulations of the German medical device market, and clarify product positioning and market opportunities.
• Search for Partners: Establish sales channels and cooperative relationships by participating in international medical device exhibitions, recruiting local agents, or joint-venturing and cooperating with German enterprises.

Market access stage

• Registration Application: Prepare product registration application forms, technical documents, product labels and instructions, etc. according to relevant German and EU regulations, and submit registration applications to relevant German regulatory authorities.
• Appoint an Authorized Representative: Manufacturers from non-EU countries usually need to appoint an authorized representative in the EU to be responsible for their legal responsibilities in the EU.

Certification stage

• CE Certification: Ensure that products meet the requirements of the EU Medical Device Regulation (MDR) and obtain the CE certification mark.
• UDI system: Assign a Unique Device Identification (UDI) to the device and reflect it on the label and packaging to improve the traceability of the device.

Logistics transportation and customs declaration

• Packaging: Ensure that the packaging of medical devices complies with German and international transportation packaging standards and can protect the products from damage during transportation.
• Select a Mode of Transport: Select an appropriate mode of transport, such as air or land transport, according to product characteristics, quantity, delivery time, etc.?Ocean shipping?Customs Declaration:
• Go through the procedures, provide accurate customs declarations, invoices, packing lists and other documents, pay tariffs, value-added taxes and other fees, strictly abide by German customs regulations and procedures to ensure the smooth customs clearance of products. Process?Customs Declaration?Training and Technical Support:

After - sales service stage

• Provide German customers with product usage training and technical support to ensure the normal operation and maintenance of products. Warranty and Repair:
• Formulate a sound warranty policy, cooperate with local agents or partners to provide timely after-sales service and repair support. Market Feedback Collection:
• Maintain close communication with customers, collect market feedback to improve products and services. Medical Device Regulation (MDR) 2017/745

II. Regulatory framework and market access

EU regulations:

• MDR is the core regulation in the field of medical devices in the EU, covering all aspects from design to market launch, with particular attention to the safety and performance requirements of devices.
  In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
• Sets strict standards for the safety and performance of in vitro diagnostic devices.
  Medical Device Implementation Act (MPDG)

German national regulations:

Germanys implementation rules based on EU regulations clarify the additional requirements for medical devices in the German market, including language, registration and regulatory details.
Device Classification

III. Compliance assessment and CE certification

Compliance assessment:

• Medical devices are classified into Class I, Class IIa, Class IIb and Class III according to their risk levels. High-risk categories need to pass the review of a Notified Body.
  Technical Document Preparation
• Includes risk assessment reports, performance test data, clinical evaluation reports, etc.
  The CE mark indicates that the device complies with EU regulatory requirements and is a pass to enter the German and the entire EU market. Manufacturers need to issue a Declaration of Conformity.

CE certification:

• CE Mark
  Economic Operator Registration
• UDI system
  Assign a Unique Device Identification (UDI) to the device and reflect it on the label and packaging to improve the traceability of the device.

IV. Registration and market supervision

EUDAMED database registration:

• Manufacturers, importers and authorized representatives need to register relevant information in EUDAMED.
  Product Information Entry
• Ensure that the technical, clinical and label information of the device is completely recorded in the database.
  Monitoring System

Post - market monitoring and reporting:

• Establish and implement a post-market performance and safety monitoring system for devices.
  Incident Report
• Incident Report
  Report major safety incidents and corrective measures to the Federal Institute for Drugs and Medical Devices (BfArM) of Germany.

V. Packaging and label requirements

Label content:

• Language Requirements
  All labels and instructions must be in German.
• Basic Information
  Including device name, purpose, manufacturer information, batch number or serial number, expiration date, special storage conditions, CE mark (with the notified body number).
• UDI requirements
  Attach the UDI to the label and packaging to ensure traceability in the supply chain.

Instruction for use (IFU):

Provide detailed instructions for use, including installation, operation, maintenance and safety precautions.

Environmental protection label:

• Recycling Mark
  Comply with the EUs Packaging and Packaging Waste Directive, use recyclable materials and mark the environmental protection logo on the packaging.
• Packaging Material Requirements
  The packaging materials must comply with environmental protection regulations. Especially for the sterilized packaging of medical devices, it is necessary to ensure sterility until the point of use.

VI. Responsibilities of importers and distributors

Verification obligation

Ensure that the imported medical devices have obtained CE certification and the manufacturer has fulfilled all regulatory obligations.

Record - keeping

Retain records of complaints, non - conforming products and recalls.

Storage and Transportation

Ensure that the medical devices remain compliant during storage and transportation.

VII. Other Key Precautions

Clinical Evaluation:

Ensure that the product has verified its safety and performance through clinical evaluation.

Data Protection:

Comply with the EUs General Data Protection Regulation (GDPR) when collecting and processing personal data.

Environmental Compliance:

Comply with the Waste Electrical and Electronic Equipment Directive (WEEE) and properly dispose of medical device waste.

After-sales Service:

Establish a complete after - sales service system to provide customers with technical support and rapid - response maintenance services, ensuring the performance and safety of the product throughout its life cycle.

VIII. Summary

Exporting medical devices to Germany is not only an important opportunity for business development, but also a test of the companys compliance capabilities. From understanding the regulatory framework, obtaining CE certification, to improving labels and packaging, every link must be strictly implemented. Especially in terms of market access and subsequent supervision and management, by keeping an eye on regulatory updates and adjusting products and processes in a timely manner, can the company remain invincible in the German medical market.

For more support, please contact a professional?Import/export?service organization. We will provide you with all - round support from certification to logistics, making your export business more stable!