ComplianceOnline

Japan's Medical Device Evaluation & Approval Process: Submitting the STED (Summary Technical Document)

Instructor: David Dills
Product ID: 701306
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This Japan's Medical Device training will guide you through the Evaluation and Approval process and applying the terminology, like Shonin, Ninsho, Kyoka, and MAH.

Why should you Attend:

Understand Japans' medical device approval and evaluation process and what it takes to make it successful. The Japanese MHW requires that all medical products sold in the country be registered. Ensuring that Japanese citizens will have access to the newest technology in medical devices and that devices will be safe and effective are the goals of this agency.

The Japanese expect the manufacturers and importers of medical devices to be socially responsible. MHW, therefore, maintains stringent quality standards for medical products as well as for device manufacturing or importing facilities. Consistent with these MHW regulations, the Japanese government demands that foreign medical manufacturers maintain either a direct or an indirect physical presence in Japan to ensure an immediate response to safety problems related to the use of a medical device.

A medical device manufacturer, whether domestic or foreign, must first obtain two types of consent from MHW: a kyoka (license) and a shonin (approval). A kyoka provides the medical device manufacturer or distributor with authorization to market its products in Japan.

He Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF), a voluntary partnership of government and industry representatives from the United States of America and four other member states: Australia, Canada, the European Union, and Japan. GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.

The proposed harmonized format and content is described in the document titled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices,” which represents the proposed STED document. The document was developed by Study Group 1 (SG1) of GHTF and issued as a proposed document on December 16, 2003. While the use of the STED format is still in its early stages, it has the long-term potential to standardize the format of regulatory submissions across jurisdictions. The STED harmonized submission format is already accepted by multiple regulatory authorities worldwide. Learn more about Pharmaceutical & Medical Devices Agency-the ONLY organization in Japan who does review the product registration applications (including the clinical trials) for Approval (both for pharmaceutical and medical device products). It also manages all the adverse event/side effect reports and provides the safety related information to public.

PMDA was established, in April 2004, in an effort to create a more efficient and transparent medical device registration review process. The Japanese government demands that foreign medical manufacturers maintain either a direct or an indirect physical presence in Japan to ensure an immediate response to safety problems related to the use of a medical device. A medical device manufacturer, whether domestic or foreign, must first obtain two types of consent from MHW: a kyoka (license) and a shonin (approval). A kyoka provides the medical device manufacturer or distributor with authorization to market its products in Japan. Many U.S. based device firms need to understand and apply the basic fundamentals and meet the minimum expectations. One key document is the STED.

The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF), a voluntary partnership of government and industry representatives from the United States of America and four other member states: Australia, Canada, the European Union, and Japan. GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.

Areas Covered in the seminar:
  • Learn more about the Medical Device Evaluation Process.
  • Understand and apply the terminology, like Shonin, Ninsho, Kyoka, MAH and others.
  • How to prepare and submit the STED and submissions that are not eligible for participation in the STED Pilot Program.
  • What goes into the STED and understand the outline.
  • Identify and understand the differences between high risks (Class 4) versus lowest risk (Class 1) devices.
  • Understand why CDRH makes reference and suggests that firms use the STED template.
  • Understand why the guidelines and other supplemental sources are important as you manage the process.
  • Learn why PMDA reviews devices in high risk categories.


Who Will Benefit:

This webinar will provide valuable assistance and guidance to all medical device companies and user facilities involved in distributing and marketing their medical devices in Japan. The employees who will benefit include:

  • All levels of Management for all departments and those who desire a better understanding or a "refresh" overview of the Japan's Medical Device Evaluation and Approval Process.
  • Regulatory Affairs
  • Marketing & Sales/Customer Service
  • Engineering/Technical Services/Operations
  • Consultants/Distributors
  • Regulatory Affairs and Compliance
  • Compliance

Instructor Profile:
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and 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. He serves 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 currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

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