eIFU of medical device in China

Servicios eIFU simplificados para dispositivos médicos en China: Cumplimiento normativo para fabricantes extranjeros


Con el avance de las soluciones digitales, los fabricantes extranjeros de dispositivos médicos que buscan acceder al mercado chino están adoptando cada vez más las instrucciones de uso electrónicas (eIFU). Esta transición no solo facilita el cumplimiento normativo en China, sino que también se alinea con los estándares globales de privacidad, incluido el Reglamento General de Protección de Datos (RGPD) de la UE. Al utilizar los servicios de eIFU, los fabricantes garantizan la seguridad y el acceso a la información del dispositivo, agilizan las actualizaciones y reducen la necesidad de documentación física.


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


Existe un control estricto, especialmente en la aduana china. Sería útil que se indicara dónde encontrar el manual de instrucciones electrónico (eIFU). Otra opción prudente es enviar solo un manual de instrucciones impreso por pedido desde el extranjero a 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. Cumplimiento de la normativa china sobre dispositivos médicos.


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. Adaptación al RGPD en materia de seguridad de datos para fabricantes de la UE.


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. Eficiencia de costos y beneficios ambientales


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. Preparación y traducción de documentos

  • Traducir todas las instrucciones de uso y los documentos de cumplimiento al mandarín, garantizando la precisión lingüística y la conformidad con la normativa para los usuarios del dispositivo en 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.



Etiquetado chino