EasyChinapprov           

Agile project of global registration of medical device

Workshop of Chinese registration

Workshop for US and EU manufacturer in Chinese market

Why This Workshop?


Registering a medical device in China requires a shift in mindset for US and EU manufacturers accustomed to FDA or EU MDR regulatory frameworks. The National Medical Products Administration (NMPA) operates under unique standards, processes, and timelines, making it essential to adapt strategies and practices to succeed in this rapidly growing market.


This workshop is tailored for US and EU or other manufacturers aiming to understand and navigate the complexities of Chinese medical device regulations effectively.

 


Key Differences Between FDA, EU MDR, and NMPA


FDA:

  • Risk-based device classification (Class I, II, III).
  • Emphasis on premarket notification (510(k)) and premarket approval (PMA).

EU MDR:

  • Lifecycle approach with stringent post-market surveillance.
  • Focus on clinical evidence and compliance with harmonized standards.
  • Detailed technical documentation aligned with IMDRF principles.

NMPA (China):

  • Mandatory type testing by Chinese-certified laboratories.
  • Device classification, testing, and approval processes specific to Chinese regulations.

 


Workshop Objectives


By the end of this workshop, participants will:

  1. Understand the regulatory differences between FDA/EU MDR and NMPA requirements.
  2. Learn how to prepare technical document for Chinese registration
  3. Gain insights into adapting device design, testing, and quality systems for the Chinese market.
  4. Develop strategies to manage timelines, overcome challenges, and avoid common pitfalls.
  5. Post market surveillance including overseas inspection.

 


Workshop Structure


The workshop in onsite way is interactive after introduction of following basic knowledge. We will start generate trouble in field and find own solution in group work.


Introduction to the Chinese Regulatory Landscape

  • Overview of NMPA’s role and key regulations.
  • Comparison of FDA, EU MDR, and NMPA processes.
  • Common misconceptions about registering medical devices in China.


Key Regulatory Requirements in China

  • Device classification under Chinese regulations.
  • Preparing the Product Technical Requirement (PTR) document.
  • Mandatory type testing: Scope, processes, and timelines.
  • Labeling and Unique Device Identification (UDI) in China.


Preparing for Registration

  • Step-by-step guide to compiling the Chinese Technical Documentation (TD).
  • Adapting clinical evidence and testing reports for Chinese standards.
  • Role of local Chinese agents and authorized representatives.


Managing Challenges and Timelines

  • Addressing deficiencies and responding to NMPA queries.
  • Strategies for efficient communication and project management.
  • Case studies: Lessons learned from successful and failed registrations.


Post-Market Compliance and Continuous Improvement

  • Updating documentation for re-registration and lifecycle management.
  • Leveraging lessons from Chinese registration for other emerging markets.

 

Alternative Learning Options


  1. Pre-Workshop Assessment: Participants can assess their knowledge of Chinese regulations and submit existing documents for review.
  2. Post-Workshop Self-Study: Engage in guided case studies and review supplementary materials to reinforce learning.

 


 

Target Audience


This workshop is designed for:

  • US and EU regulatory affairs professionals managing Chinese registrations.
  • US/EU manufacturer with their Chinese partners
  • Quality managers, product developers, and project managers adapting to NMPA requirements.
  • Manufacturers entering the Chinese market for the first time or optimizing existing registrations.

 


Cost and Duration


Costs and duration vary based on:

  • Device complexity and project scope.
  • Number of participants and prior experience with Chinese registration.

Standard Format:

  • 2-3 sessions focusing on practical exercises and case studies.
  • Delivered remotely or in person (primarily in Europe, around Germany).

 


Why Join This Workshop?


This workshop equips US and EU manufacturers with the knowledge, tools, and strategies to transition smoothly from FDA/EU MDR frameworks to NMPA requirements. It bridges the gap between global and Chinese regulatory practices, empowering participants to achieve efficient and compliant market entry.


The most clients end our workshops with improved regulatory KPI in Chinese business up.

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