2023-06-03 2023-06-03 , online online, 1,150 € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://www.forum-institut.de/seminar/23062501-medical-devices-in-china/referenten/23/23_06/23062501-course-seminar-webcast-online-zoom-medical-devices-in-china_fischer-stefan.jpg Medical Devices in China

Would you like to successfully approve and market your medical devices in China as well? Then attend our webcasts and learn more about market potential and product approvals. Our local experts will provide you with comprehensive information - especially on the subject of approval and risks that exist for European medical device manufacturers or importers.

Topics
  • Market potential for European companies in the Chinese market
  • Product approval
  • NMPA (CFDA): Documents, procedures, fees - tips and tricks
  • Clinical pathways
  • Post-market Surveillance & Quality Management System
  • Latest regulatory changes


Who should attend
The webcasts are aimed at specialists and managers in the medical device and IVD industry who are planning medical device marketing or renewing an existing marketing authorization in China. This online event is of particular interest for the following departments:
  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Marketing and product management
  • Distribution and sales
Aims and objectives
China continues to drive forward the expansion of its healthcare system - especially after "Corona". Imported medical devices and MedTech products are increasingly meeting with local competitors. At the same time, the requirements and costs for the registration of medical devices are increasing. New distribution structures are required.

These two interactive live online events will highlight the opportunities and potential of European medical devices and technology on the Chinese market. The requirements for the registration of medical devices are described in details.

Let us show you what the regulatory novelties in China entail and which are significant for you as an European medical device manufacturer. 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

  • Highlighting opportunities and potential of European medical devices and technology in the Chinese market.
  • Detailed description of requirements for the registration of medical devices in China
  • Insight into regulatory novelties in China.
  • Opportunity to learn about significant regulatory factors for European medical device manufacturers.
  • Direct interaction with local experts during Q&A sessions.

Medical Devices in China

Medical Devices in China

Market Potential and Product Approval

Benefits
  • Get tips for a successful approval
  • Up-to-date information on the latest regulatory changes
  • Receive a certificate after passing the online test

Webcode 23062501

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

27-28/06/2023

27-28/06/2023

Zeitraum

9 - 12 am CET

9 - 12 am CET
Veranstaltungsort

online

online

Gebühr
Your contact

Antje Bauer
Conference Manager

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

Details

Would you like to successfully approve and market your medical devices in China as well? Then attend our webcasts and learn more about market potential and product approvals. Our local experts will provide you with comprehensive information - especially on the subject of approval and risks that exist for European medical device manufacturers or importers.

Topics
  • Market potential for European companies in the Chinese market
  • Product approval
  • NMPA (CFDA): Documents, procedures, fees - tips and tricks
  • Clinical pathways
  • Post-market Surveillance & Quality Management System
  • Latest regulatory changes


Who should attend
The webcasts are aimed at specialists and managers in the medical device and IVD industry who are planning medical device marketing or renewing an existing marketing authorization in China. This online event is of particular interest for the following departments:
  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Marketing and product management
  • Distribution and sales
Aims and objectives

China continues to drive forward the expansion of its healthcare system - especially after "Corona". Imported medical devices and MedTech products are increasingly meeting with local competitors. At the same time, the requirements and costs for the registration of medical devices are increasing. New distribution structures are required.

These two interactive live online events will highlight the opportunities and potential of European medical devices and technology on the Chinese market. The requirements for the registration of medical devices are described in details.

Let us show you what the regulatory novelties in China entail and which are significant for you as an European medical device manufacturer. 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

  • Highlighting opportunities and potential of European medical devices and technology in the Chinese market.
  • Detailed description of requirements for the registration of medical devices in China
  • Insight into regulatory novelties in China.
  • Opportunity to learn about significant regulatory factors for European medical device manufacturers.
  • Direct interaction with local experts during Q&A sessions.

Detailed programme

9 - 12 am CET

Complete Lifecycle Supervision
  • Post-market surveillance & quality management system
  • Handling of adverse events
  • Recall
  • PRER
  • Sampling inspection
  • Overseas factory inspections
  • Other pathways: Fast track, GBA, Hainan

Hot Topics & Latest Regulatory Changes
  • Cyber security & Chinese company name
  • Lifetime of medical devices
  • Electronic application submission (eRPS) & UDI
  • Medical device master file
  • Advertising and human factors design
  • From foreign-to-China & unauthorized claims
  • Localization: tips and tricks
  • Penalties and confidentiality code
  • Trade fairs & industry associations

Complete Lifecycle Supervision
  • Post-market surveillance & quality management system
  • Handling of adverse events
  • Recall
  • PRER
  • Sampling inspection
  • Overseas factory inspections

  • Other pathways: Fast track, GBA, Hainan

Hot Topics & Latest Regulatory Changes
  • Cyber security & Chinese company name
  • Lifetime of medical devices
  • Electronic application submission (eRPS) & UDI
  • Medical device master file
  • Advertising and human factors design
  • From foreign-to-China & unauthorized claims
  • Localization: tips and tricks
  • Penalties and confidentiality code
  • Trade fairs & industry associations

Unser Partner

WVG

Die Wissenschaftliche Verlagsgesellschaft Stuttgart (WVG) ist ein medizinisch-naturwissenschaftlicher Fachmedien- und Zeitschriftenverlag, der zur Mediengruppe Deutscher Apotheker Verlag gehört. Das umfangreiche Verlagsprogramm finden Sie auf der Homepage.


Further information

Questions?

The participants are warmly invited to also contribute their own experiences for a thorough exchange! Please send your topic at least 10 working days before the start of the webcasts to a.bauer@forum-institut.de

How does it work?

The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Use the chat function to ask questions

FAQ

1.) You need a reliable Internet connection and a browser. The following Windows browsers are applicable:
- Internet Explorer 8 onwards
- Mozilla Firefox
- Google Chrome

2.) We recommend using the Zoom app to connect with your mobile device.
- You will need a headset, loudspeakers, or a telephone for audio.

3.) Can I test my equipment beforehand?
- Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

This distinguishes our events

Seminar content: 100% of the participants’ feedback was very good or good. (June 2022)

Recommendations

Aufbauwissen für den Großhandelsbeauftragten

Virtuelles Aufbauseminar zu weitergehenden Verantwortlichkeiten und Pflichten des Großhandelsbeauftragten

20.06.2023, Online
Details

PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...

01.11. - 31.10.2024, Online
Details

Produktinformationstexte auf dem aktuellsten Stand halten

Dieses Online-Seminar informiert Sie über Ihre Aktualisierungspflichten bei SmPC und Packungsbeilage und die behördlich ...

21.06.2023, Online
Details

Qualitätsbedingte Variations

Online-Seminar mit Fokus: Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige?

03. - 04.07.2023, Online
Details

Regulatory Affairs Manager*in

Der/die Regulatory Affairs Manager*in ist Neuzulassungsmanager*in, Fristenmanager*in, Dokumentenmanager*in und Projektma...

28. - 29.06.2023, Online
Details

Go forward

Masterclass China

Medical Device Marketing Authorisation for Advanced

Details
Masterclass China
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Acronyms/Glossary
Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

Details
More on our quality criteria

Testimonials


Very informative on various topics of Medical device registration in China


Expectations: to get an overview of the most important steps / issues in MD registration in China. My expectations were met.


Ms. Anna King: clear speaking and very interesting to listen