CRO’s 2019 - Live Webinar Regulatory Requirements for Registration of Medical Device Products in China

Overview
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
Session Highlights
• 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.
• CRO’s
• Regulatory Affairs
• RA Specialists
• Clinical Affairs
• Quality Control/Quality Assurance
• Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services
• Consultants
• Manufacturing
• Auditors
Speaker
David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments. He leads and directs all activities for the product registration and approval process and working with the regulatory agencies in Asia Pacific (APAC), EU, Latin America (LATAM), Middle East, EMEA, including but not limited to FDA, European Medicines Agency, MHRH, ANVISA, MOH, PMDA, MOH, TFDA, MDCO, CFDA, TGA, Health Canada and others regarding multi-country product registrations and licensing. Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities while developing strategies for governmental approval to introduce new products to market. He conducts communications with regulatory authorities and company representatives while executing an effective path to approval and helping with GxP compliance strategies in global markets.