eIFU of medical device in China

Streamlined eIFU Services for Medical Devices in China: Compliance for Foreign Manufacturers

As digital solutions advance, foreign manufacturers of medical devices seeking access to the Chinese market are increasingly adopting electronic instructions for use (eIFU). This transition not only supports regulatory compliance in China but also aligns with global privacy standards, including the EU General Data Protection Regulation (GDPR). By utilizing eIFU services, manufacturers ensure secure and accessible device information, streamline updates, and reduce physical documentation requirements.

How is regulation and praxis of eIFU in China?

• Regulation

There is no requirement as at “Provisions for Instructions and Labels of Medical Devices” that eIFU is not allowed in China. In one Q/A on web of authority it explains that eIFU received by users should be consistent with approved IFU of medical device.

• Praxis

There is control especially at Chinese customs. If it was indicated where to find eIFU, it is useful. Another conservative way is to deliver only one paper IFU per one order from overseas to China.

• Our associated hypothesis related to MDR in EU

We worked with notified body checking firm portal publishing eIFU and validation of eIFU-tool. We speculate that China aligns with EU in the future with some basic requirements of eIFU, probably max. not permitted for some devices with rational trouble of eIFU.

Key Benefits of eIFU Services in China

1.    Compliance with Chinese Medical Device Regulations

In China, electronic documentation for medical devices must meet strict standards. Our eIFU services ensure compliance with the National Medical Products Administration (NMPA) guidelines, which require all device documentation to be accessible, accurate, and available in Mandarin for local users.

2.    Alignment with GDPR for Data Security for EU manufacturers

Given that personal data of users may be embedded within eIFU systems, our service ensures strict adherence to GDPR, especially for EU-based manufacturers. We implement robust data encryption and access control to safeguard users’ personal information, thereby fulfilling GDPR obligations.

3.    Cost Efficiency and Environmental Benefits

Moving to eIFU reduces the environmental and financial impact associated with printing and distributing paper manuals. This digital transition simplifies updates and reduces overhead, benefiting both the company and the consumer.

How Our eIFU Service Works: A Step-by-Step Workflow

Below is a streamlined workflow designed to meet both Chinese regulatory requirements and GDPR standards, providing a secure and user-friendly eIFU service.

eIFU Workflow for Compliance and Security

1.     Document Preparation and Translation

• Translate all IFUs and compliance documents into Mandarin, ensuring language accuracy and regulatory alignment for device users in China.

2.     Data Encryption and GDPR Compliance

• Implement secure data storage and encryption methods to protect personal data, compliant with GDPR, to meet EU standards even within the Chinese market.

3.     Digital Accessibility and User Support

• Make the eIFU available through a secured portal or QR code on the device packaging. The eIFU is accessible 24/7, with a customer support line available for additional guidance.

4.     Ongoing Compliance Monitoring and Updates

• Regularly update eIFUs to reflect changes in regulations or product specifications, ensuring the latest and most accurate information is always available to end users.

Ensuring Comprehensive Compliance and User-Centric Solutions

Our eIFU service provides a comprehensive solution that not only fulfills Chinese regulatory requirements but also ensures data protection, safeguarding user privacy at every level. With an efficient, user-friendly process in place, foreign manufacturers can confidently navigate the Chinese market while maintaining high standards of compliance and accessibility.

Besides it, you can use our “easyIFU” tool to let your users worldwide have access of all languages of IFU.