Applus+ Laboratories invites you to attend the public welfare training on medical device market entry (EU MDR session)!

12/06/2026

    In recent years, China’s medical device exports have continued to grow, providing domestic manufacturers with unprecedented development opportunities. However, they also face challenges such as differences in overseas regulations and the difficulty of obtaining product certification.

    • Start date: 12/06/2026
    • End date: 12/06/2026
    • City: Hangzhou
    • Country: China

    To address key compliance challenges associated with accessing the EU market—including EU MDR requirements, clinical evaluation, quality management systems, cybersecurity, biological safety, and CMR compliance—the Hangzhou Municipal Administration for Market Regulation has invited a professional EU MDR compliance and certification body to deliver its first public training session on EU medical device market access.

    The event will take place on June 12, 2026, in Hangzhou.

    Applus+ Laboratories will collaborate with REACH24H Consulting Group to deliver this training session focused on EU MDR requirements for medical devices.

    The Hangzhou Municipal Administration for Market Regulation has specially invited a professional EU medical device MDR compliance and certification body to host the first public welfare training session on medical device entry into the EU MDR market on June 12, 2026, in Hangzhou.

    Applus+ Laboratories once again joins forces with REACH24H Consulting Group to jointly launch this public welfare training seminar focused on medical device entry into the EU market.

    The session will include contributions from CE MDR Notified Body auditors, nationally registered QMS/EMS/OHSMS auditors, and a senior Marketing Director from the Medical Division, offering insights into current regulatory expectations.

    Applus+ Laboratories is a testing, inspection, and certification provider with experience in the medical device sector. It operates as an EU MDR Notified Body (NB 2764 and NB 3121) and maintains a global laboratory network supporting testing and evaluation activities for international market access.

    Seminar Topics:

    • EU Medical Device Regulation MDR (CE) compliance strategies
    • How preclinical large animal studies can meet MDR requirements
    • EU CMR requirements and analysis of typical cases
    • MDR (CE) cybersecurity project case studies and testing analysis
    •  In-depth interpretation of ISO 10993-1:2025 | Differences between the new and old standards and compliance strategies
    •  ISO 13485 quality management system training
    • How clinical trial data from China can meet MDR requirements
    • Clinical evaluation of medical devices under EU MDR

    Seminar Information:

    Time: June 12, 2026 (Friday)

    Location: 4th Floor Conference Room, Building 1, No. 17 Wuzhou Road, Donghu Subdistrict, Linping District, Hangzhou (enter through the west gate of Hangzhou Weice Biotech).

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