Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)

Course "Medical Device Registration and Approval Process for the Pacic Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers 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 device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness

 Overview:

• Classification systems differ from that of the United States or European Union in select countries
• Medical devices are classified depending on their risk level
• Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements
• Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia
• The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear.
• In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy.
• And Much More...

 Why should you attend:

• Learn and understand the entire Registration and Approval Process
• Identify and understand the changes to Medical Device Registration Process in select countries
• Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
• Learn how to access new markets and obtain medical device approval in all the countries listed
• Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
• Navigate the regulatory system, achieve product registration, and access the medical market
• In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions.
• Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions

 Areas Covered in the Session:

• Which regulatory bodies are responsible for medical device registration in each country?
• Are medical devices required to be registered before they can be sold?
• What are the different regulatory classifications for medical devices?
• What are the different application categories for medical device registration?
• What does the registration pathway look like for each regulatory classification?
• What are the document requirements for notification for the various classes of medical devices?
• What are other requirements that are necessary for approval in addition to the device application?
• Is local testing (type testing/sample testing) required for registration?
• When are clinical studies required for registration?
• Is approval in the Country of Origin required for registration?

 Who will benefit:

This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Asia Pacific and with the corresponding regulatory authorities. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the medical device registration process, including:

• Clinical Research Associates
• Clinical Project Managers
• Regulatory Affairs Professionals
• Clinical Investigators and Clinical Research
• Regulatory Affairs Management
• Regulatory Affairs Specialists
• Regulatory Project Leads/SME's
• Auditors
• Compliance Specialists
• Clinical Affairs
• Quality Assurance
• Consultants
• Distributors