In collaboration with the FORUM Institut, the webcasts will highlight the opportunities and potential of European medical devices and technology on the Chinese market for three consecutive days. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.
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.
Register now through this link to receive a 10% discount.
Agenda
February 23 – Part 1
09:00 – 09:15 Welcome
- with a short introduction round at the beginning. Each participant could briefly share information about their company and their past experience in China
09:15 – approx. 11:00
Topic: 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
- Government healthcare
- Regulatory framework
- Registration – types
- Development of product registration/2019 NMPA report
- NMPA legal agent
- Market authorization holder system
February 24 – Part 2
09:00 – 09:05 Welcome
09:05 – approx. 11:00
Topic: China Registration
- Classification of medical devices
- Registration Processes & timelines
- Application file checklist
- PTR (Product Technical Requirement)
- Standards
- Type Tests
- NMPA website and database
- 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
February 25 – Part 3
09:00 – 09:05 Welcome
09:05 – approx. 11:00
Topic: Complete Lifecycle Supervision
- Post-market surveillance & quality management system
- Handling of adverse events
- Recall
- PRER
- Sampling inspection
- Overseas factory inspections
Topic: Other Pathways
- Fast track: innovation, priority, emergency approval
- Hainan Pilot Zone
- Hong Kong MDACS listing & Greater Bay Area
- CBEC
Topic: Hot Topics & Latest Regulatory Changes
- Cyber security
- Chinese company name
- Lifetime of medical devices
- Electronic application submission (eRPS)
- Unique Device Identification (UDI)
- Medical Device Master File
- Advertising
- Human factors design
- From foreign-to-China
- Unauthorized claims
- Penalties
- Confidentiality code
- Trade fairs
- Industry associations
Contact Cisema if you would like to learn more.
