2024-06-21 2024-06-21 , online online, 1,190 € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://www.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
  • Quality agreements and master files
  • Regulatory pathways, clinical exemptions, UDI
  • Usability engineering and AI software
  • NMPA inspections and change approvals
  • EU PMCF and real-world evidence


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.

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 of medical device marketing authorisation in China is required.
Aims and objectives
Explore advanced insights into China's latest regulatory changes, pre-market registration optimization, and the post-market surveillance system in our seminar.

Our local experts, based in Hong Kong and mainland China, provide you with the latest insights and knowledge on the registration authorities in China.

Your questions and discussions are encouraged! Take advantage of the opportunity to interact directly with local experts during Q&A sessions. Join us for a streamlined and informative experience.
Your benefit

Acquire up-to-date knowledge on China's NMPA registration authorities.

  • Efficiently optimize pre-market registration (PMR) with minimal effort and cost.
  • Understand the acceptance of European regulatory testing in China.
  • Gain insights into clinical pathways from feasibility studies to clinical trials and exemptions.
  • Enhance cooperation with your NMPA Local Authorized Representative.
  • Learn the latest in Quality Agreements, MDMF, and Combined Products.
  • Leverage RWE research and generative AI for market advantage.
  • Navigate volume-based procurement requirements and explore strategies to avoid them.
  • Benefit from the expertise of local professionals based in China & Hong Kong

Masterclass China: Medical Device Market Authorisation for Advanced

Masterclass China

Pre-Market Registration and Post-Market Surveillance in China

Benefits
  • Best strategy for a fast registration
  • MD & Combination products
  • 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

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

  • Quality agreements and master files
  • Regulatory pathways, clinical exemptions, UDI
  • Usability engineering and AI software
  • NMPA inspections and change approvals
  • EU PMCF and real-world evidence


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.

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 of medical device marketing authorisation in China is required.

Aims and objectives

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

Our local experts, based in Hong Kong and mainland China, provide you with the latest insights and knowledge on the registration authorities in China.

Your questions and discussions are encouraged! Take advantage of the opportunity to interact directly with local experts during Q&A sessions. Join us for a streamlined and informative experience.

Your benefit

Acquire up-to-date knowledge on China's NMPA registration authorities.

  • Efficiently optimize pre-market registration (PMR) with minimal effort and cost.
  • Understand the acceptance of European regulatory testing in China.
  • Gain insights into clinical pathways from feasibility studies to clinical trials and exemptions.
  • Enhance cooperation with your NMPA Local Authorized Representative.
  • Learn the latest in Quality Agreements, MDMF, and Combined Products.
  • Leverage RWE research and generative AI for market advantage.
  • Navigate volume-based procurement requirements and explore strategies to avoid them.
  • Benefit from the expertise of local professionals based in China & Hong Kong

Detailed programme

9 - 12 am CET

09:00 - 12:00

Pre-market Registration (PMR)
  • Quality agreements for entrusted manufacturing
  • Medical device master files (MDMF)
  • Combination products
  • Pathways, including the Hainan pre communication and Greater Bay Area pre-submissions to access the GBA "connect scheme"
  • Clinical trials and exemptions
  • Clinical evaluations and exemptions
  • Usability engineering requirements and human factors design
  • Generative AI and analysis software
  • Unique Device Identifier
  • Benefit risk assessments
  • Nanomaterials

09:00 - 12:00

Post-market Surveillance (PMS)
  • NMPA inspections
  • Sampling inspections
  • Change approvals
  • EU PMCF - how to take advantage of in China market observational studies to fulfil EU PMCF requirements
  • Real world evidence research
  • Insurance codes and reimbursements
  • Volume based procurement requirements and how to avoid them

Our partner

Cisema

Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the China and Hong Kong market, with a large on-the-ground contingent of local Chinese staff and satellite sales offices around the world with someone that speaks your language. Our special focus is China regulatory affairs for product registration. Cisemas expertise includes the NMPA (formerly known as CFDA) registration for medical devices, IVDs, pharmaceuticals (DMF), cosmetics, health food and other life sciences products.



Further information

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.

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

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

Recommendations

Verantwortliche Personen nach Art. 15 MDR

Erfahren Sie, was Sie in Ihrer Rolle als PRRC beachten müssen und welche Herausforderungen auf Sie warten. Dieses Online...

26.09.2024, Online
Details

Verpackungen von Medizinprodukten

In diesem Seminar lernen Sie, welche Verpackung für welches Medizinprodukt geeignet ist und welche verschiedenen normati...

12.09.2024, Online
Details

Praxistraining Fachtechnisch verantwortliche Person

Dieses Seminar informiert Sie detailliert über den Verantwortungsbereich der Fachtechnisch verantwortlichen Person (FvP)...

26.09.2024, Online
Details

Kennzeichnung, Verpackung und Marketing von Kosmetika

Erhalten Sie ein Update und einen umfassenden Überblick über den regulatorischen Rahmen der Kennzeichnung, Verpackung un...

09.10.2024, Online
Details

Erfolgreiche medizinische Fortbildungsveranstaltungen

Workshop - so gelingt die strategische Planung und Durchführung von medizinischen Fortbildungsveranstaltungen

27.08.2024, Online
Details

Go forward

Global Medical Device Registration

Are you interested in a worldwide registration of medical devices? Our webcast series "Global Medical Device Registratio...

Details
In-house seminars

Our programmes are also available for in-house training. Just contact us!

Details
In-house seminars
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality