Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices (NTZ)
Mon, Oct 16, 2017, 9:00 AM –
Tue, Oct 17, 2017, 6:00 PM
Course "Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
-Japan's classification system differs from that of the United States or European Union
-Medical devices are classified to Class I, II, III, or IV depending on their risk level
-Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements
-Strict new package insert requirements
-Change to MAH Licensing rules
-A new MAH License category for In Vitro Diagnostic (IVD) devices
-A new registration system for manufacturers
-A new QMS conformity assessment system
-New formats for pre-market certification and pre-market approval applications
-Expanded scope of third party certifications
- Rules for software as a medical device
-Rules for transferring pre-market certifications
-And Much More...
Why should you attend:
-Understand the entire Registration and Approval Process in Japan
-Identify and understand the Major Changes to Medical Device Registration Process in Japan
-Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
-Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions
-Review and discuss pain points, challenges and solutions
Areas Covered in the Session:
-Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
-In Japan, 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 Japan. 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
Day 1 Schedule
Lecture 1: Medical Device Registration and Approval Process
-Introductions and Background
-What is the classification scheme for medical devices?
-What are the registration procedures?
-How are devices classified?
-How do regulatory requirements differ for domestic vs. foreign manufacturers?
-How long does it take to register devices?
-New Registration Pathways for Manufacturers
-Revised medical device registration and approval requirements in Japan
-Some Class III medical devices can undergo third party certification
-Medical software programs are independently regulated
-Manufacturers are required to be registered rather than be licensed
-Quality management systems (QMS) are streamlined
-QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products
-Changes to Marketing Authorization Holder System
-Key Guidelines and Resources
-Will our clinical studies and testing conducted outside Japan be accepted?
Lecture 2: Exercise and Recap of Day 1
Review of Regulatory Documents
Day 2 Schedule
Lecture 1: Medical Device Registration and Approval Process
-Medical Device Registration and Approval Process and Recap from
-Documentation required for review and approval
-Registration and JMDN Codes
-QMS and other requirements
-Documentation and Additional Materials for Registration and Approval
-Consultation sessions with Regulatory Authority, how to maximize foreign clinical data, and how to expedite product registration
-Trends and lessons learned with recent and current registrations
-New medical device regulations and approval requirements are released on a regular basis sometimes and companies must keep track and current
-Regulatory inspection process
Lecture 2: Exercise and Recap of Day 2
-Review of Regulatory Documents
Lecture 3: Debrief/Adjourn
-Recap of topics and key discussion points and take away message
-FAQs and latest trends
David R. Dills
Global Regulatory Affairs & Compliance Consultant
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. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.