2023-06-03 2023-06-03 , online online, 1,190 € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://www.forum-institut.de/seminar/23122500-masterclass-china-medical-device-marketing-authorisation-for-advanced/referenten/23/23_12/23122500-medical-devices-china-market-access-marketing-authorisation_fischer-stefan.jpg Masterclass China: Medical Device Marketing Authorisation for Advanced

Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!

Topics
  • Update your regulatory knowledge
  • Pre-Market Registration (PMR): Minimalise your efforts and costs
  • Acceptance of European registration tests
  • Clinical pathways: From feasibility study report to a clinical trial
  • Perfect your cooperation with your NMPA legal agent
  • Chinese IFU and label


Who should attend
The webcasts are aimed at specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments:
  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Product management
  • Distribution and sales

Basic knowledge on medical device marketing authorisation in China is a prerequiste for the training.

Aims and objectives
China for advanced: Get your deep dive in latest regulatory changes, optimisation of PMR and Chinese post-market surveillance system.

The two webcasts will provide detailed updates about recent regulatory changes in China - including the new medical device law which came into force in 2021 and continues to generate substantial new subsidiary regulation. Last, but not in least, our local experts will address the PMS and related change management with many examples.

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.
Your benefit

  • Up-to-date knowledge of the registration authorities in China. Optimisation of pre-market registration (PMR) with minimal effort and cost. Understanding the acceptance of European regulatory testing in China. Insights into clinical pathways from feasibility study report to clinical trial. Improved cooperation with the NMPA legal representative. Information on the Chinese Instructions for Use (IFU) and label requirements.

Masterclass China: Medical Device Market Authorisation for Advanced

Masterclass China

Medical Device Market Authorisation for Advanced: Pre-Market Registration and Post-Market Surveillance in China

Benefits
  • Find the best strategy for a fast registration for your product.
  • Requirements for the legal agent in China.
  • Minimalise your efforts and costs.
  • Live discussion with local experts.

Webcode 23122500

Jetzt buchen

JETZT Buchen
Referenten

Dipl.-Ing. Stefan Fischer

Cisema (Hong Kong) Limited

Founder & Managing Director; Stefan Fischer is currently managing director of Cisema (Hong Kong) Ltd. in Hong Kong His areas of expertise are product safety approvals as well as customs regulations in the PRC. This includes as well as medical technology registrations and "China Compulsory Certification" (CCC).
More information please click here.

BA/LLB, RAC Hamish King

Cisema (Hong Kong) Limited

Chief Operating Officer

Dipl. BWL Guo Ning

Cisema Beijing Consulting Ltd.

General Manager Beijing

Alles auf einen Blick

Termin

05-06/12/2023

05-06/12/2023

Zeitraum

9 - 12 am CET

9 - 12 am CET
Veranstaltungsort

online

online

Downloads
Gebühr

Veranstaltung - 1,190 € zzgl. MwSt.
The attendance fee includes the download of documentation and your certificate.

Veranstaltung - 1,190 € zzgl. MwSt.
The attendance fee includes the download of documentation and your certificate.

Jetzt buchen

Your contact

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!

Topics
  • Update your regulatory knowledge
  • Pre-Market Registration (PMR): Minimalise your efforts and costs
  • Acceptance of European registration tests
  • Clinical pathways: From feasibility study report to a clinical trial
  • Perfect your cooperation with your NMPA legal agent
  • Chinese IFU and label


Who should attend
The webcasts are aimed at specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments:
  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Product management
  • Distribution and sales

Basic knowledge on medical device marketing authorisation in China is a prerequiste for the training.

Aims and objectives

China for advanced: Get your deep dive in latest regulatory changes, optimisation of PMR and Chinese post-market surveillance system.

The two webcasts will provide detailed updates about recent regulatory changes in China - including the new medical device law which came into force in 2021 and continues to generate substantial new subsidiary regulation. Last, but not in least, our local experts will address the PMS and related change management with many examples.

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.

Your benefit

  • Up-to-date knowledge of the registration authorities in China. Optimisation of pre-market registration (PMR) with minimal effort and cost. Understanding the acceptance of European regulatory testing in China. Insights into clinical pathways from feasibility study report to clinical trial. Improved cooperation with the NMPA legal representative. Information on the Chinese Instructions for Use (IFU) and label requirements.

Detailed programme

9 - 12 am CET

Day 1: Pre-Market Registration (PMR)
  • Products Technical Requirement (PTR): How to write the PTR to minimalize the efforts and costs of change management
  • Registration tests: What must be done in China and what can be done in your own country
  • Clinical pathways
    • From feasibility study report (FSR) to a clinical evaluation report (CER) to a clinical trial: How to find the best pathway and strategy for your individual product?
  • In-depth analysis: How to accelerate the complete process of registration.

Day 2: Post-Market Surveillance (PMS)
  • Legal agent: What must they do for you in China and how can you cooperate
  • Chinese instruction for use (IFU) and label: Who is responsible and how to manage
  • Change management: Systematic analyzation of different change types and examples
  • Random sampling test in China: Facts and trends
  • Adverse Event (AE): How can you establish a system to manage AE

End of the webcasts
We have prepared an online test for you to test your knowledge.
Once you have taken this test, you will have online access to your certificate.

You will find the online test on your learning platform, for which we will send you separate access data.

Our partner

Lexxion Verlagsgesellschaft mbH


Wissenschaftliche Verlagsgesellschaft Stuttgart



Further information

What are the advantages of our online courses?

  • Online courses - live and interactive via Zoom.
  • Your access data and all accompanying documents always accessible in your customer portal.
  • Didactically and technically optimally coordinated concept with plenty of room for your questions.
  • Free PreMeeting for a technically perfect start to your online training.
  • Continuous support during the online seminar for optimal learning success.

Frequently asked questions

1) What are the system requirements?
You need a stable internet connection. The following browsers are possible under Windows, for example:
  • - Internet Explorer version 8.0 or higher
  • - Mozilla Firefox
  • - Google Chrome

For participation via mobile devices, we recommend the Zoom app. You will need a headset, loudspeaker or telephone to transmit the sound.
For more information, please visit: Zoom Support

2) Can I do a technology check in advance?
You can carry out a technology check in advance to ensure that everything works at the actual online seminar.
The technology check can be carried out at: Zoom Test

3) Do I have to use a PC headset for the online seminar?
No, Zoom supports dial-in via telephone in addition to all standard PC microphones or speakers. However, working with a PC headset is much more comfortable for online seminars.

This distinguishes our events

Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

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