Clinical Strategy China (NMPA)
From MDR Approval to Market Access
- 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
Online-Seminar
Ab
1.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.090,-€ zzgl. MwSt.
The participation fee includes a documentation download, a certificate, access to the Learning Space, and technical support including a pre-meeting.
Period:
both days from 09:00 - 11:30 CEST
You may dial in 30 min in advance
Buchungsdetails
Online-Seminar
Ab
1.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.090,-€ zzgl. MwSt.
The participation fee includes a documentation download, a certificate, access to the Learning Space, and technical support including a pre-meeting.
Period:
both days from 09:00 - 11:30 CEST
You may dial in 30 min in advance
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.
Your speakers
Nick Guo
Cisema Beijing
General Manager
Nick Guo is General Manager at Cisema Beijing, the largest office
of Cisema Group which is a regulatory consultancy firm based in Beijing offering regulatory, quality and…
Your speaker
Nick Guo
Cisema Beijing
General Manager
Nick Guo is General Manager at Cisema Beijing, the largest office
of Cisema Group which is a regulatory consultancy firm based in Beijing offering regulatory, quality and clinical consulting services for China arket entry. Cisema was founded in 2002 in Munich, Germany and in Beijing and has nearly 100 staff across its global offices. Nick has studied and worked in China and Germany, which leads to a deep understanding of culture diversities from East and West.
With almost 20 years of consulting experience in China and Europe, he has developed a wealth of expertise in China market access focusing on health care products including drugs, medical device, health food and cosmetics. He is fluent in German, English and Chinese and regularly speaks in conferences, seminars, webinars and education sessions about China product registration and other regulatory and quality subjects. He has done more than 300 factory audits worldwide in different industry fields like medical devices, automobiles and special equipment.
Zimo Chu
Cisema Beijing
Project Manager for China clinical trials
Zimo CHU is a Project Manager at Cisema Beijing. Cisema Group, is a regulatory consulting firm founded in 2002.
Zimo brings extensive consulting…
Your speaker
Zimo Chu
Cisema Beijing
Project Manager for China clinical trials
Zimo CHU is a Project Manager at Cisema Beijing. Cisema Group, is a regulatory consulting firm founded in 2002.
Zimo brings extensive consulting experience in China and professional exposure in Europe, with a strong focus on China market access strategies for healthcare products (including pharmaceuticals and medical devices) and clinical trial project management for both medical devices and pharmaceuticals. Her academic and professional background spans both China and the UK, equipping her with deep cross-cultural understanding. Fluent in English and Chinese, Zimo has also conducted over 100 global factory audits across diverse sectors such as medical devices, automotive, and specialty equipment.
What to Expect
- 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.
Objective of the Event
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.
Programme
Both days from 09:00 - 11:30 CEST
Day 1
09:00
09:15
Zimo Chu, Nick Guo
- 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
- 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
10:30
Zimo Chu, Nick Guo
- 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
Regulatory Framework and Clinical Evaluation Pathways
Welcome and Participant Round
09:15
Introduction: Regulatory Framework
Introduction: Regulatory Framework
Zimo Chu, Nick Guo
- 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
Pathway Selection and CER Strategies
Pathway Selection and CER Strategies
Zimo Chu, Nick Guo
- 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)
Coffee Break
10:30
FSR and Clinical Trials in China
FSR and Clinical Trials in China
Zimo Chu, Nick Guo
- 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
End of Day 1
Day 2
09:00
09:15
Zimo Chu, Nick Guo
- 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
10:30
Zimo Chu, Nick Guo
- 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 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
Operational Implementation and Practical Insights
Q&A of Day 1
09:15
Study Design, Sites and Compliance
Study Design, Sites and Compliance
Zimo Chu, Nick Guo
- 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
Coffee Break
10:30
Data Management and PMCF
Data Management and PMCF
Zimo Chu, Nick Guo
- 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
IP Protection, Pitfalls and Wrap-Up
IP Protection, Pitfalls and Wrap-Up
Zimo Chu, Nick Guo
- 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
End of Seminar
Downloads
Request the documents using our form.
Brochure
Abbreviation List: Medical Devices
Further Informations
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.
Access to and procedure for online events
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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Further Information
Newsletter on trends and findings
Stay up to date - we regularly inform you about new regulatory and professional developments.
In-house seminars
Our programmes are also available for in-house training. Just contact us!
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de