2024-04-12 2024-04-12 , online online, 1,190 € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://forum-institut.de/seminar/24062502-medical-devices-in-china/referenten/24/24_06/24062502-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
  • National Medical Products Administration (NMPA): Documents, procedures, fees - tips and tricks
  • Clinical pathways
  • Post-market Surveillance & Quality Management System
  • Latest Regulatory Changes and Trends


Who should attend
This course is 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 training 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
The National Medical Products Administration (NMPA) has been established in China since 2018, replacing the former State Food and Drug Administration (CFDA). The NMPA is responsible for regulating medical devices in China and ensures that the quality and safety of medical devices are standardized.

China is the second largest healthcare market in the world. For many medical device manufacturers, it is a challenge to fulfill the dynamically changing regulatory requirements. It requires knowledge and support to navigate the market successfully. However, China’s large and ageing population makes it an attractive healthcare market that offers numerous opportunities for foreign companies.

If you are looking to enter the Chinese market or seeking deeper understanding to unlock key pain points, our local Hong Kong and China mainland experts can answer all your regulatory questions and help you navigate the market successfully.

These two interactive live online trainings will highlight the opportunities and potential of European medical devices and technology for the Chinese market. The requirements for the registration and ongoing compliance of medical devices are described in detail.

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
  • local experts from Hong Kong, China
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24062502

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

04-05/06/2024

04-05/06/2024

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

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
  • National Medical Products Administration (NMPA): Documents, procedures, fees - tips and tricks
  • Clinical pathways
  • Post-market Surveillance & Quality Management System
  • Latest Regulatory Changes and Trends


Who should attend
This course is 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 training 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

The National Medical Products Administration (NMPA) has been established in China since 2018, replacing the former State Food and Drug Administration (CFDA). The NMPA is responsible for regulating medical devices in China and ensures that the quality and safety of medical devices are standardized.

China is the second largest healthcare market in the world. For many medical device manufacturers, it is a challenge to fulfill the dynamically changing regulatory requirements. It requires knowledge and support to navigate the market successfully. However, China’s large and ageing population makes it an attractive healthcare market that offers numerous opportunities for foreign companies.

If you are looking to enter the Chinese market or seeking deeper understanding to unlock key pain points, our local Hong Kong and China mainland experts can answer all your regulatory questions and help you navigate the market successfully.

These two interactive live online trainings will highlight the opportunities and potential of European medical devices and technology for the Chinese market. The requirements for the registration and ongoing compliance of medical devices are described in detail.

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

Medical Device Market in China and Introduction to NMPA Registration
  • Market dynamics and potential
  • Access to healthcare facilities
  • Megatrends? Digitalization & selfcare
  • Regulatory bodies: SAMR & NMPA & CMDE
  • Regulatory framework
  • Registration - types
  • Latest NMPA registration statistics and trends
  • NMPA legal agent
  • Market authorization holder system

Medical Device Market in China and Introduction to NMPA Registration (Part 2)


China Registration (Part 1)
  • Classification of medical devices
  • Registration Processes & timelines
  • Application file checklist
  • PTR (Product Technical Requirement)
  • Standards
  • Type Tests
  • NMPA website and database

End of day 1


China Registration (Part 2)
  • Chinese label
  • Official fees
  • Clinical pathways: Exemptions, overseas clinical trials, predicate devices (CER), clinical trials in China
  • Customized medical devices
  • Combination products
  • Software & AI regulations, registration, software update

Complete Lifecycle Supervision
  • PRER
  • Sampling inspection
  • Overseas factory inspections
  • Certificate Management: The challenge to manage different changes and renewals in an optimal way
  • UDI 
  • Post-market surveillance & Quality management system
  • QMS Annual Self-assessment report
  • Handling of adverse events
  • Insurance Code and Bidding Support

Break


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

End of seminar


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 v.planitz@forum-institut.de

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.

This distinguishes our events

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

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Go forward

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses.

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Our international course portfolio
List of abbreviations

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

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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