Entering the Chinese market offers tremendous opportunity for medical device companies, but it is not without challenges. Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms. The China Food & Drug Administration (CFDA) is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province. Medical devices require CFDA registration prior to being sold in China. The medical device classification system shares some similarities with U.S. and European standards. Under the China medical device regulations, Class I devices are simple devices that can be effectively monitored through regular administration while Class III devices are complex implants or life supporting devices. Medical Device Classification rules were issued in State Drug Administration’s Order Number 15. The Center for Medical Device Evaluation (CMDE) is responsible for reviewing relevant documents during the registration process. Foreign manufacturers that export medical devices to China need to hire local agents to act as their representatives during the registration process. Manufacturers must have a local agent on hand to deal with adverse events as well as handle support and communication. The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In China, it can also become difficult to make a clear distinction between your regulatory strategy and business strategy. Learn how to prepare the necessary documents and register your product with the Chinese regulatory authorities
- Determine device classification
- What are the different regulatory classifications for medical devices?
- What does the registration pathway look like for each regulatory classification?
- What are the document requirements for registration for each regulatory classification?
- Determine if clinical trials will be needed for your device
- When are clinical studies required for registration?
- Ascertain the best route to CFDA approval in China
- Compile the registration application and Technical Requirement document
- Is local testing (type testing/sample testing) required for registration?
- Coordinate product testing in China
- Is approval in the Country of Origin required for registration?
- Prepare final submissions
- CFDA Regulatory Approval Process and Timelines
Who will Benefit
All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of working with State Food and Drug Agency and navigating the regulatory landscape.
- Regulatory Affairs
- RA Specialists
- Clinical Affairs
- Quality Control/Quality Assurance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty David R. Dills
David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.