China is today one of the largest markets for medical devices worldwide and, for international manufacturers, a key target market of high strategic importance. Market access for medical devices, however, is associated with considerable regulatory requirements. Registration constitutes a demanding and resource-intensive process. Against this background, there is a strong need for a sound regulatory understanding in order to realistically assess registration strategies and efficiently prepare market access processes.
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This training provides a structured overview of the Chinese medical device registration system. It explains the relevant regulatory stakeholders, the registration process and key requirements.
Main Topics Covered
Regulatory Authorities and Requirements in China
- Role and responsibilities of the National Medical Products Administration (NMPA)
- Tasks and working methods of the Center for Medical Device Evaluation (CMDE)
-Structure and size of the technical review teams
· Overview of relevant regulations and guidelines
- Comparison of the Chinese regulatory framework with the EU (MDR) and the USA (FDA)
The Registration Process for Medical Devices in China
- Classification of medical devices in China
-Classification criteria and practical implications
- Product Technical Requirements (PTR) and Type Testing
-Significance, contents, and regulatory function
- Application dossier and prerequisites
-Structure of the documentation and key review focus areas
- Submission and supplementary submission
-Review by CMDE as well as consultations with the CMDE reviewer
· Changes to the product after registration
-Requirements for change registrations
Trends and Outlook
- “Made in China 2025” and “China for China” approach
- Medical Pilot Zone in Hainan
- Outlook on the China Medical Device Law
Key Benefits
- Gain a clearly structured overview of the Chinese regulatory framework for medical devices
- Understand the roles of NMPA and CMDE, as well as their expectations in the registration process
- Get to know the essential steps, requirements, and challenges of medical device registration in China
- Gain a structured understanding of the definition, significance, structure, and requirements of the PTR.
- Recognize key differences from the EU and US regulatory systems and avoid misconceptions carried over from other jurisdictions
Target Audience: Participants who work operationally on a Chinese registration, e.g. Regulatory Affairs Managers. Participants who need to understand regulatory structure, processes and decision-making logic in order to competently manage internal strategies, project decisions and external service providers, e.g. project managers, R&D leads or executives
Trainer: Zhencan Xu
A Medical Device Consultant at FSQ Experts with a focus on international registration, from the development of regulatory strategies through to full submission for international markets.
Auditors
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Zhencan Xu
Moderator
Zhencan Xu is a Medical Device Consultant at FSQ Experts, specializing in international regulatory affairs, from the development of regulatory strategies through to complete submissions for international markets. She supports manufacturers in efficiently meeting regulatory requirements and structuring market access in a strategic and well-organized manner.
She has a technical background, holding a Bachelor’s degree in Mechanical Engineering from the Technical University of Munich and a Master’s degree in Medical Engineering. Through her diverse project experience—including systems engineering, risk management, product development and regulatory submissions. She has gained a comprehensive understanding of the entire medical device lifecycle from different perspectives, combining strong technical expertise with in-depth regulatory knowledge.