Requirements for Registration of Medical Device Products in China

Duration: 60 Minutes
China's medical device market is rapidly growing these years, China offers numerous opportunities for foreign healthcare related companies but understanding the practicalities of accessing the market is not simple. Attend this training, if you are a manufacturer or distributor involved in exporting medical devices or IVDs to China, this webinar will provide you with necessary briefing on CFDA registration of medical devices.
CFDA registration of medical devices
Instructor: David R Dills
Product ID: 502010
Objectives of the Presentation
  • 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
Why Should you Attend
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.

Who will Benefit
This webinar will provide valuable and additional insight and an overview for the medical device and IVD companies who desire to pursue registration and approval in China. Employees and personnel who will benefit include:
  • All levels of management and departmental representatives
  • 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
$375
Recorded Session for one participant
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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