Posted: 2 February 2023
Event: 27 March 2023
Workshop Overview
Will highlight the opportunities and potential of Australian medical devices and technology in the Chinese market. The requirements for the registration of medical devices are described in detail. Let us show you what the regulatory novelties in China entail and which are significant for you as an Australian medical device manufacturer.
- The market potential for Australian 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 virtual classroom is aimed at specialists and managers in the medical device and IVD industry who are planning medical device marketing or renewing an existing marketing authorisation in China.
Workshop highlights
Medical Device Market in China and Introduction to NMPA Registration
- Market dynamics and potential
- Access to healthcare facilities
- Megatrends, Digitalisation and selfcare
- Regulatory bodies in China (including SAMR, NMPA and CMDE)
- Government healthcare
- Regulatory framework and registration types
- Development of registration/2019 NMPA report
- NMPA legal agent and market authorisation holder system
China Registration
- Classification and registration: Processes and timelines
- Application file checklist, PTR, standards and type tests
- NMPA website and database; Chinese label and fees
- Clinical pathways: Exemptions, overseas clinical trials, predicate devices (CER), clinical trials in China
- Customised medical devices and combination products
- Software and AI regulations, registration, SW update
Complete Lifecycle Supervision
- Post-market surveillance (PMS) and QM system
- Handling of AE, recalls and PRER
- Sampling inspection
- Overseas factory inspections
- Other Pathways: Fast track, Hainan Pilot Zone a. o.
Hot Topics & Latest Regulatory Changes
- Cyber security and Chinese company name
- Lifetime of medical devices
- Electronic application submission (eRPS) and UDI
- Medical device master file
- Advertising and human factors design
- From foreign-to-China and unauthorised claims
- Penalties and confidentiality code
- Trade fairs and industry associations
Aim and objectives
Will highlight the opportunities and potential of Australian medical devices and technology in the Chinese market. The requirements for the registration of medical devices are described in detail. Let us show you what the regulatory novelties in China entail and which are significant for you as an Australian medical device manufacturer.
