Skip to Content

Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

Start Date:
Thursday, 12 October, 2017
End Date:
Friday, 13 October, 2017 6:00pm
Hepatology, Pulmonary Medicine, Family Practice, Sports Medicine, Headache / Migraine, Health & Nutrition

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. Overview: Japan's classification system differs from that of the United States or European UnionMedical devices are classified to Class I, II, III, or IV depending on their risk levelMedical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirementsStrict new package insert requirementsChange to MAH Licensing rulesA new MAH License category for In Vitro Diagnostic (IVD) devicesA new registration system for manufacturersA new QMS conformity assessment systemNew formats for pre-market certification and pre-market approval applicationsExpanded scope of third party certificationsRules for software as a medical deviceRules for transferring pre-market certificationsAnd Much More...

Why should you attend: Understand the entire Registration and Approval Process in JapanIdentify and understand the Major Changes to Medical Device Registration Process in JapanStreamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely mannerParticipants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissionsReview 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· Auditors· Compliance Specialists· Clinical Affairs· Quality Assurance· Consultants· Distributors Agenda:Day 1 Schedule Lecture 1: Medical Device Registration and Approval ProcessIntroductions and BackgroundWhat 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 ManufacturersRevised medical device registration and approval requirements in JapanSome Class III medical devices can undergo third party certificationMedical software programs are independently regulatedManufacturers are required to be registered rather than be licensedQuality management systems (QMS) are streamlinedQMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual productsChanges to Marketing Authorization Holder SystemKey Guidelines and ResourcesWill our clinical studies and testing conducted outside Japan be accepted? Lecture 2: Exercise and Recap of Day 1Interactive DiscussionsReview of Regulatory Documents Day 2 Schedule Lecture 1: Medical Device Registration and Approval ProcessMedical Device Registration and Approval Process and Recap from Day 1Documentation required for review and approvalRegistration and JMDN CodesIn-Country Representative/DMAHQMS and other requirementsDocumentation and Additional Materials for Registration and ApprovalConsultation sessions with Regulatory Authority, how to maximize foreign clinical data, and how to expedite product registrationTrends and lessons learned with recent and current registrationsNew medical device regulations and approval requirements are released on a regular basis sometimes and companies must keep track and currentRegulatory inspection processLecture 2: Exercise and Recap of Day 2Interactive DiscussionsReview of Regulatory DocumentsLecture 3: Debrief/AdjournRecap of topics and key discussion points and take away messageFAQs and latest trends SpeakerDavid R.

DillsGlobal 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. Location: Zurich, SwitzerlandDate: October 12th & 13th, 2017and Time: 9:00 AM to 6:00 PMVenue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50 Price: Register now and save $200. (Early Bird)Price: $1,695.00 (Seminar Fee for One Delegate)Until August 31, Early Bird Price: $1,695.00 From September 01 to October 10, Regular Price: $1,895.00Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Contact us today! NetZealous LLC DBA Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: Registration Link - Follow us on LinkedIn: us our Facebook page: us on Twitter: Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Hilton Zurich Airport

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Event Manager

Medical conference data provided by Meetings4Docs | Report a problem

Upcoming Related Conferences

Oct 12

Medical CBT for Anxiety: Ten-Minute Techniques for Real Doctors (South Pacific cruise, 2019) 13 - 27 April m/s Paul Gauguin Papeete, Tahiti French Polynesia
Listed in: Family Practice