2026-04-08 2026-04-08 , online online, 1,090 € zzgl. MwSt. Nick Guo https://www.forum-institut.de/seminar/26092503-clinical-strategy-china-nmpa/referenten/26/26_09/26092503-clinical-strategy-china-nmpa_guo-nick.jpg Clinical Strategy China (NMPA)

This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework. Building on existing MDR approvals, it provides a structured approach to pathway selection, evidence gap analysis, study planning and compliant execution in the Chinese market.

Topics
  • NMPA Regulatory Framework for Medical Device Clinical Evaluation
  • Clinical Evaluation Pathways: CER, Clinical Trials and RWD
  • Study Design and Conduct in China
  • Data Management, PIPL Compliance and PMCF
  • NMPA Submission Pitfalls, IP Protection and Timelines


Who should attend
Professionals and senior leaders in the medical device industry with solid experience in clinical evaluation and clinical investigations under the EU MDR who are strategically preparing market access in China.
Aims and objectives
This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework.

Day 1 focuses on the strategic and regulatory dimension: participants learn how to navigate the NMPA's clinical evaluation pathways, assess which existing MDR data are transferable and determine whether additional clinical evidence is required.

Day 2 addresses operational implementation: participants gain practical knowledge on site selection, GCP compliance, data management and how to avoid common pitfalls that lead to delays or rejections.
Your benefit

Upon completing this seminar, participants will be able to:

  • Systematically evaluate which clinical data from an existing MDR dossier the NMPA accepts and where evidence gaps remain.
  • Select the optimal clinical evaluation pathway (CER, overseas data study, RWD or clinical trial) based on a structured decision logic.
  • Plan and manage clinical investigations in China, including study design, site selection and investigator qualification.
  • Navigate the key differences between Chinese GCP (2020 revision) and ISO 14155 to ensure compliant study conduct.
  • Address data transfer requirements under PIPL and design data management processes that satisfy both MDR and NMPA standards.

clinical-strategy-china-nmpa

Clinical Strategy China (NMPA)

From MDR Approval to Market Access

Benefits
  • Know your MDR data gaps
  • Pick the right NMPA pathway
  • Prevent delays and NMPA rejections
  • Case studies included
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 26092503

Jetzt buchen

JETZT Buchen
Referenten

Nick Guo

Cisema Beijing

General Manager

Zimo Chu

Cisema Beijing

Project Manager for China clinical trials

Alles auf einen Blick

Termin

23 - 24/09/2026

23 - 24/09/2026

Zeitraum

both days from 09:00 - 11:30 CEST

both days from 09:00 - 11:30 CEST
Veranstaltungsort

online

online

Downloads
Abbreviation Medical Devices
Abbreviation Medical Devices
Gebühr

Event - 1,090€ plus tax
The participation fee includes a documentation download, a certificate, access to the Learning Space, and technical support including a pre-meeting.

Event - 1,090€ plus tax
The participation fee includes a documentation download, a certificate, access to the Learning Space, and technical support including a pre-meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework. Building on existing MDR approvals, it provides a structured approach to pathway selection, evidence gap analysis, study planning and compliant execution in the Chinese market.

Topics

  • NMPA Regulatory Framework for Medical Device Clinical Evaluation
  • Clinical Evaluation Pathways: CER, Clinical Trials and RWD
  • Study Design and Conduct in China
  • Data Management, PIPL Compliance and PMCF
  • NMPA Submission Pitfalls, IP Protection and Timelines


Who should attend
Professionals and senior leaders in the medical device industry with solid experience in clinical evaluation and clinical investigations under the EU MDR who are strategically preparing market access in China.

Aims and objectives

This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework.

Day 1 focuses on the strategic and regulatory dimension: participants learn how to navigate the NMPA's clinical evaluation pathways, assess which existing MDR data are transferable and determine whether additional clinical evidence is required.

Day 2 addresses operational implementation: participants gain practical knowledge on site selection, GCP compliance, data management and how to avoid common pitfalls that lead to delays or rejections.

Your benefit

Upon completing this seminar, participants will be able to:

  • Systematically evaluate which clinical data from an existing MDR dossier the NMPA accepts and where evidence gaps remain.
  • Select the optimal clinical evaluation pathway (CER, overseas data study, RWD or clinical trial) based on a structured decision logic.
  • Plan and manage clinical investigations in China, including study design, site selection and investigator qualification.
  • Navigate the key differences between Chinese GCP (2020 revision) and ISO 14155 to ensure compliant study conduct.
  • Address data transfer requirements under PIPL and design data management processes that satisfy both MDR and NMPA standards.

Detailed programme

both days from 09:00 - 11:30 CEST

08:40 Day 1: Regulatory Framework and Clinical Evaluation Pathways


09:00 Welcome and Participant Round


09:15

Zimo Chu, Nick Guo

Introduction: Regulatory Framework
  • Brief introduction to China's NMPA medical device clinical evaluation regulatory framework (adapted for EU client understanding)
  • Core objectives of this training: clarify the logic for selecting clinical evaluation pathways to facilitate compliant and efficient advancement

09:25

Zimo Chu, Nick Guo

Pathway Selection and CER Strategies
  • Step 1: Determination of Clinical Evaluation Exemption
    • Scope and criteria for clinical evaluation exemption by China's NMPA (focus on low-risk devices)
    • Key points and common misunderstandings in exemption applications
  • Step 2: Classification of Core Pathways for Devices Requiring Clinical Evaluation
    • Two core pathways: Clinical Evaluation Report (CER) vs. clinical trial
    • Core principles for pathway selection (risk level, device characteristic adaptation)
  • Step 3: Detailed Explanation of Core CER Pathways (Including Auxiliary Pathway)
    • Pathway 1: Predicate device study (predicate device selection, data requirements, comparability demonstration)
    • Pathway 2: Overseas clinical data study (data acceptability, bridging requirements, compliance key points)
    • Auxiliary pathway: RWD (Real-World Data) study (data sources, application scenarios, verification requirements)

10:15 Coffee Break


10:30

Zimo Chu, Nick Guo

FSR and Clinical Trials in China
  • Key Support: FSR (Feasibility Study Report) as a Pathway Optimization Tool
    • Core purpose of FSR: verify the feasibility of CER pathways and select the optimal sub-pathway
    • Core content and implementation points of FSR (adapted for EU client needs)
  • Introduction to Clinical Trials in China
    • Application scenarios and core processes of clinical trials
    • Key time nodes and compliance considerations

11:30 End of Day 1


08:40 Day 2: Operational Implementation and Practical Insights


09:00 Q&A of Day 1


09:15

Zimo Chu, Nick Guo

Study Design, Sites and Compliance
  • Study Design for China
    • Study type, sample size planning, endpoints, study duration and follow-up requirements
  • Clinical Sites and Investigators
    • NMPA-certified hospitals, investigator qualification, interaction with the local agent at the clinical level, and its impact on study quality, site selection and communication with authorities
  • Study Compliance and Operational Considerations
    • Chinese GCP (2020 revision) compared to ISO 14155: practically relevant differences, ethics committee procedures, amendments, informed consent, and NMPA inspections during ongoing studies

10:15 Coffee Break


10:30

Zimo Chu, Nick Guo

Data Management and PMCF
  • Data Transfer and Data Management
    • Personal Information Protection Law (PIPL) requirements, local data storage, and unified eCRF design meeting both MDR and NMPA requirements
  • Post-Market Clinical Follow-up in China

11:00

Zimo Chu, Nick Guo

IP Protection, Pitfalls and Wrap-Up
  • IP Protection in the Clinical Context
  • Common Pitfalls and Lessons Learned
    • Frequent reasons for NMPA queries and rejections in the clinical dossier, avoidable delays in study planning and conduct, and realistic timelines

11:30 End of Seminar


More information

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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