Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices andor products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before Wholesale NFL Jerseys China , during, and after importing into the U.S. or its territories. All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.
This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E--Imports and Exports. Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number Wholesale NFL Jerseys , foreign establishment registration number and name of U.S. agent, medical device listing number, and Premarket Notification 510(k) or Premarket Approval number, if applicable. For exporting Wholesale Jerseys Cheap , while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). Learn the process for unapproved and approved medical devices to be exported and the documentation process involved.
Areas covered in the session: Examine the import and export requirements for medical devicesIntroduction to FDA references and guidance documents related to import and export requirementsUnderstand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S. Import AlertsRecordkeeping requirements and your responsibilitiesHow to export unapproved and approved medical devices Who will benefit: This webinar will provide valuable assistance and guidance to device companies involved in importing and exporting of medical devices. Employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a “refresh“ overview of the exportimport processRegulatory AffairsClinical AffairsQuality and ComplianceMarketing & Sales DistributorsAuthorized RepresentativesEngineeringTechnical ServicesOperationsConsultants GlobalCompliancePanel plays a role of bringing together the regulators or experts on regulation with the community who needs to learn or be aware of those regulations. GlobalCompliancePanel is started with the goal to create an excellent interactive platform for the experts and the user community thereby making costs of training more affordable with increased convenience.
GlobalCompliancePanel strives to understand the changing customer needs and enrich their quality of life by simply providing world-class training to increase their productivity and professional growth. Global Compliance Panel enables the companies in triggering business processes through regulatory notifications and industry alerts.
Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00 webinars@globalcompliancepanel http:www.globalcompliancepanel Phone: 800-447-9407Fax: 302-288-6884 If your product or service can be given as a gift, a publicity windfall awaits at the end of the year - but you need to start working in June. Each December, media outlets cover the newest Wholesale Jerseys Online , the hottest and the most unusual Holiday gifts. The reporters assigned to develop these pieces typically depend on two sources of information:
1. Phone interviews with local store owners
- and -
2. Press materials that have been sent by publicity seekers.
Let's deal with Point 1. Here's a cool trick: In early November, write a letter to stores and major websites that carry your product. Remind them that they may be hearing from journalists soon about hot gift ideas, and request that they consider mentioning your product when that happens. Point out a few reasons why your product is the newest, coolest Wholesale Jerseys Free Shipping , best or whatever. Ask the vendor to drop you an e-mail or give you a call if a story results that mentions your product.
Now, on to old-fashioned publicity. When to contact the media depends on the publication or program's lead time (how far in advance of publication or airing the material is developed). Magazines like Woman's Day have a lead time up to six months, so get materials to them now. Newspapers have a lead time as short as a week for feature material, so send materials in November. In between are wire services Wholesale Jerseys From China , medium-lead magazines, "in-flight" magazines and others. To learn the lead time of a particular media outlet, call the editorial department. If that doesn't work, try the advertising department.
What you send should be kept simple -- a press release about your productservice Wholesale Jerseys China , a pitch letter explaining why it's such a great gift idea, and, if applicable, a disk with color product photos. See our articles "How to Write a Great Pitch Letter" and "How to Write a Great Press Release" for more details.