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    International Product Registration: Documents Required

    View: 234

    Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500964?expDate=Sep9_2015_Internat | Want to Edit it Edit Freely

    Category medical device manufacturing, medical device compliance, medical device registration, medical device regulation, international product registration

    Deadline: September 08, 2015 | Date: September 09, 2015

    Venue/Country: online Webinar, U.S.A

    Updated: 2015-08-28 16:10:09 (GMT+9)

    Call For Papers - CFP

    International Product Registration: What are the documents required?

    Instructor: Marie Dorat

    Product ID: 500964

    Description

    The focus of this session is international product registration for IVDs & Medical Devices. Product registration requirements have changed with new regulations across the globe. Requirements have been clarified and in some cases the registration timeframe has been reduced. In Hague convention member states and non-Hague member states, companies can lose revenue simply by not having the right legalized documents or specific government stamps and authentications.

    Why Should you Attend

    Industry Executives and investors are complaining these days that their competitive edge is being jeopardized by the heightened regulatory scrutiny. For device companies based in the US, there is a growing trend in commercializing their products outside the country. In particular, many US-based companies are targeting new markets in the EU, China and, increasingly, India.

    The process for approval or clearance of devices varies from each regulatory body. In some cases, products achieve regulatory approval in an efficient and timely manner. In others, including the US FDA, companies may face a protracted and delayed approval process. Recent scrutiny by US regulators and legal authorities is making it more uncertain for companies attempting to gain market access in foreign countries.

    In an economy where getting the jump on your competitors is very important, this training will provide a guide to ease international registrations and reduce time to market. Learning the relevant regulatory requirements and the appropriate document legalization path will speed up the pathway.

    Objectives of the Presentation

    International regulation- Overview of country by country differences

    Roles and responsibilities of US manufacturers & in-country distributors

    Identifying the key players

    Working with in-country distributors

    Sales forecasting ? Who needs to know?

    Types of documents needed

    Medical Device & IVDs

    Best practices for document legalizations

    Apostille vs. Authentications

    How to get documents embassy legalized

    Pitfalls ? What to look out for

    Who can Benefit

    Regulatory Affairs Specialist/Managers

    Product Managers

    Marketing Professionals

    Administrative Professionals

    For Registration-

    http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500964?expDate=Sep9_2015_InternationalProductReg=Channel=ourglocal

    Note : Use coupon code 1371 and get 10% off on Registration


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.