Workshop of chinese technical document

What is Chinese Technical Documentation (TD)?

Chinese Technical Documentation (TD) is technical files required for medical device registration with the National Medical Products Administration (NMPA). These documents include detailed information about the design, manufacturing process, performance, and safety of the device, ensuring compliance with Chinese regulatory standards.

Chinese TD differs significantly from its counterparts in the EU (e.g., EU MDR Technical Documentation) and the US (e.g., FDA Premarket Submission), as it must be aligned with unique Chinese standards, product specific guidance and regulations.

Why is Chinese TD Important?

1. Regulatory Compliance: Submitting complete and accurate TD is a non-negotiable requirement for obtaining NMPA approval.
2. Foundation for Market Entry: Chinese TD serves as the basis for type testing, registration, and post-market surveillance.
3. Inspection Readiness: TD is critical during inspections, ensuring all technical specifications are traceable and consistent.
4. Reproduce of next registration

Learning Content

By the end of this workshop, participants will:

1. Understand the structure and requirements of Chinese TD for medical device registration.
2. Learn how to create, compile, and revise TD in alignment with NMPA regulations.
3. Gain insights into common pitfalls and challenges in preparing Chinese TD.
4. Explore strategies to generate Chinese TD from  international technical documentation (e.g., EU MDR, FDA).

Workshop Structure

Fundamentals of Chinese TD

• Overview of the NMPA’s requirements for technical documentation.
• Comparison of Chinese TD with EU MDR and FDA technical documentation.
• Key elements of TD: Product description, design documents, risk analysis, clinical evaluation, and labeling.

Preparing Chinese TD

• Step-by-step guide to compiling TD for medical devices as device description.
• Organizing files: Naming conventions, version control, and folder hierarchy.

Managing Challenges in Chinese TD Preparation

• Common mistakes in TD preparation and how to avoid them.
• Best practices for responding to NMPA deficiencies.
• Case studies on resolving technical document challenges during registration.

Aligning Chinese TD with Global Standards

• Strategies for leveraging EU MDR and FDA documentation for Chinese TD.
• Harmonizing technical documentation across multiple markets.
• Tips for maintaining consistency and avoiding duplication of effort.

Alternative Learning Options

1. Pre-Workshop Self-Assessment: Participants can assess their understanding of Chinese TD and submit their existing documentation for review.
2. Self-Study Sessions: Post-workshop, participants can engage with guided case studies and supplementary materials for deeper insights.

Free Kit

Participants will receive a Chinese TD Kit, including:

• Templates for critical TD (essential principle, device description)
• A checklist for TD with requirement.
• Comparison matrix of TD between important markets

Target Audience

This workshop is ideal for:

• Regulatory affairs professionals preparing Chinese TD.
• Quality managers, product developers, and project managers involved in medical device registration.
• Companies entering the Chinese market for the first time or looking to optimize their TD process.

Cost and Duration

Costs and duration vary based on:

• The complexity of the medical devices and TD requirements.
• The number of participants and their prior experience with Chinese registration.

Standard Format:

• 2 sessions with a focus on case studies and practical exercises.
• Delivered remotely or in person (primarily in Europe, around Germany).