SEARCH
Current Location:
>
> This Story

Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More News Headlines

Pediatric Screening Devices Help Drive Preventive Care Required to Ensure Long-Term Health and Wellbeing

Hong Kong medical center unites radiotherapy systems with Elekta's MOSAIQ Oncology Information System

Lahey Health selects Premier, Inc. and Yankee Alliance to support commitment to greater value, higher quality care

New from Akro-Mils: Kanban Extended Label Holder

Olympus Expands VisiGlide Guidewire Lineup to Deliver Full Spectrum Solution for Endoscopies in the Biliary Tract

Massachusetts General Hospital implements Agfa HealthCare DR technology Hospital adds multiple mobile and full room DR solutions to increase productivity and generate industry-leading MUSICA image quality for both inpatient and outpatient departments.

MILabs launches new molecular imaging product line MILabs launches new molecular imaging product line at the European Association of Nuclear Medicine Annual Meeting.

CANON U.S.A. INTRODUCES NEW REALiS WUX6000, EXPANDING THE REALiS PRO AV INSTALLATION LCOS PROJECTOR LINE UP Canon's New Flagship Model Delivers WUXGA High Resolution, 6000-Lumen Brightness, LCOS Technology, and Multiple Genuine Canon Projection Lens Options for Imaging and Installation Versatility

Carestream's Digital X-ray System Chosen by San Francisco 49ers For Use in Diagnosing Player Injuries

PaySpan's Provider and Member reimbursement platform selected by Colorado Choice Health Plans

MITA and AdvaMed Partner to Reduce Trade Barriers, Harmonize Medical Device Standards with China

Beijing, China -The Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) yesterday concluded a series of successful activities aimed at reducing barriers to trade between China and the United States and harmonizing international standards for medical devices. The organizations participated in the U.S.-China Joint Commission on Commerce and Trade (JCCT) Pharmaceuticals and Medical Device Subgroup meeting and led a two-day standards workshop that provided China's State Food and Drug Administration (SFDA) and Chinese industry representatives with additional expertise on IEC 60601-1 third edition -- the internationally recognized standard for electrical medical equipment.

"MITA is pleased to be working closely with AdvaMed and its industry partners on efforts to help China transition to this comprehensive standard," said Gail Rodriguez, MITA executive director. "The enhanced certainties and efficiencies inherent in China's adoption of IEC 60601-1 third edition will yield significant benefits to patients and manufacturers."

Story Continues Below Advertisement

How to Get the Most Out of Your Service Providers

(and Add Value to Your Facility). Knowing where and how to add value greatly benefits your facility-- and your personal career. Read more and get a comparison tool to help you make smart decisions



"China's transition to the third edition will usher in a more collaborative era of medical standards, driven by safety and international progress in technology," said Ralph Ives, AdvaMed executive vice president for global strategy and analysis.

Working closely with the U.S. Department of Commerce and other industry partners, MITA and AdvaMed hosted a robust standards workshop on IEC 60601-1 third edition that featured industry experts and international consultants, including technical advisors, secretaries and leaders of related IEC and ISO technical committees and working groups. The purpose was to increase the Chinese government's familiarity with the standard and further expedite their transition process. To be fully representative of the global medical device industry, speakers came from North and South America, Europe and Asia.

Prior to the workshop, MITA and AdvaMed participated in the JCCT Pharmaceuticals and Medical Device Subgroup meeting, where AdvaMed led discussions on follow-up to its combination products workshop that took place in coordination with the April subgroup meeting in Shenzhen and the U.S. experience in regulating these cutting-edge therapies, which combine pharmaceutical and medical device components. At the meeting, SFDA officials expressed appreciation for the opportunity to exchange information on this challenging regulatory area and affirmed that the Chinese system has been modeled on international best practices.

Continue reading MITA and AdvaMed Partner to Reduce Trade Barriers, Harmonize Medical Device Standards with China...
  Pages: 1 - 2 >>

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2014 DOTmed.com, Inc.
ALL RIGHTS RESERVED