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...
This webinar will provide the attendees with an overview of both FDA's Low-Risk Device Draft Policy (January 2015) and guidance on Mobile Medical Applications (February 2015), along with insight as to how companies can achieve compliance with both.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link http://onlinecompliancepanel.com/webinar/FDAs-LOW-RISK-POLICY-MEDICAL-DEVICE-501520/JUNE-2016-ES-TRAININGREGISTRY
This webinar will focus on current Food and Drug Administration (FDA) Regulatory Guidance as well as current Compliance and Regulatory Trends with regards to Computer Systems Validation (CSV).This presentation will also provide the attendees with the Ultimate set of Tools in order to help their firms during a Regulatory Inspection as well as how to create the proper building blocks for Computer Systems Validation thus avoiding or minimizing risk during a regulatory inspection.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link