2024-04-15 2024-04-15 , online online, 1,190 € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://forum-institut.de/seminar/24092500-masterclass-china-medical-device-marketing-authorisation-for-advanced/referenten/24/24_09/24092500-medical-devices-china-market-access-marketing-authorisation_fischer-stefan.jpg Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success

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 (FSR) to a clinical trial
  • Post-market Surveillance (PMS): NMPA legal agent
  • Chinese Instruction for Use (IFU) and label
  • Change management
  • Facts and trends


Who should attend
The seminar is conceptualized for 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
Explore advanced insights into China's latest regulatory changes, PMR optimization, and the post-market surveillance system in our seminar.

Stay informed with detailed updates on recent regulatory shifts, notably the 2021 medical device law and its ongoing subsidiary regulations. Our local experts will share practical examples, addressing PMS and change management.

Your questions and discussions are encouraged! Seize the interactive opportunity to converse directly with local experts during Q&A sessions. Join us for a streamlined, informative experience.
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.
  • Local experts based in Hong Kong, China

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
  • Minimalise your efforts and costs
  • Live discussion with local experts
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24092500

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

10-11/09/2024

10-11/09/2024

Zeitraum

9 - 12 am CET

9 - 12 am CET
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Verena Planitz
Conference Manager

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

Details

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success

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 (FSR) to a clinical trial
  • Post-market Surveillance (PMS): NMPA legal agent
  • Chinese Instruction for Use (IFU) and label
  • Change management
  • Facts and trends


Who should attend
The seminar is conceptualized for 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

Explore advanced insights into China's latest regulatory changes, PMR optimization, and the post-market surveillance system in our seminar.

Stay informed with detailed updates on recent regulatory shifts, notably the 2021 medical device law and its ongoing subsidiary regulations. Our local experts will share practical examples, addressing PMS and change management.

Your questions and discussions are encouraged! Seize the interactive opportunity to converse directly with local experts during Q&A sessions. Join us for a streamlined, informative experience.

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.
  • Local experts based in Hong Kong, China

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.

Further information

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

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.

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.

This distinguishes our events

of 5 stars of all ratings from 2023

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