East Meets West? Devices and IVDs Regulation in Europe and the Asia Pacific

Presented by: Brandwood Biomedical and Promedt Consulting

The regulatory systems of the Asia Pacific all draw on the European/GHTF regulatory model of device classification, conformity assessment, and use of standards. Australia and Taiwan provide fast track registrations for CE marked devices. Extensive reforms in China are accelerating, alignment with the GHTF/IMDRF model. All of this provides opportunity for exporters to streamline regulatory compliance and access multiple markets with common technical dossiers.

 

This in-depth, full-day seminar will provide integrated presentations of the regulatory requirements of Europe, Australia-New Zealand and China and ASEAN and explain the commonalities that exist, the opportunities for accelerated market entry for CE marked devices and the local variations that must be addressed.

 

Agenda at a glance:

 

  • The European/GHTF paradigm
  • Upcoming changes in Europe – the new Devices Regulation
  • Eurocentric regulation in Australia and NZ
  • Accelerating harmonization in China –and the opportunities created.
  • Fast tracks in Taiwan for CE and FDA cleared devices
  • The ASEAN Directives – European regulatory models for SE Asia

 

Date and Time:

Thursday, 12 June 2014

8:30am to 5:30pm

 

Venue:

Indianapolis Chamber of Commerce

Burkhart Board Room

Chase Tower

111 Monument Circle, Suite 1900

Indianapolis, IN 46202

 

Who should attend?

Medical Device Exporters to Europe and Asia Pacific

Regulatory Affairs Professionals

International Business Development Managers

 

To register:

There is no charge to participate in this informational event. Please register on-line at:

http://www.ihif.org/conference/register/63

 

For the full event agenda, please click here

 

About the Presenters

Dr Arthur Brandwood – Founder and CEO, Brandwood Biomedical

With more than 30 years’ experience in the Medtech industry, including as Director of Devices Registration at the Australian Therapeutic Goods Administration (TGA), Dr Brandwood has extensive expertise in Regulatory Affairs and in the evaluation of medical devices and diagnostics. He is immediate past the National Chair of AusMedtech, Australia’s national Medtech industry association.

Dr Brandwood’s comprehensive knowledge of regulatory and clinical requirements combined with strong global regulator relationships has delivered a track record of success for clients ranging from small start-ups to the large multinationals. He is a passionate educator who has held academic positions in London, Sydney, Singapore and Bangkok and has delivered training and advice to regulatory agencies across Asia.

 

Lucy Xiao, Consultant – Asia Services, Brandwood Biomedical

Educated in China and Australia and with qualifications in both Biomedical and Mechanical engineering, Lucy is well versed in every step of the medical device life-cycle from conceptual design to post-marketing activities. Combining technical knowledge and regulatory expertise, Lucy supports both Australian and international clients in quality and regulatory requirements, specialising in Asian markets.

Lucy is bilingual (English and Mandarin) and is experienced in direct interactions with regulatory authorities in Greater China. Clients also benefit from the Asian regulatory intelligence she supplies with real-time regulatory announcements and trends of the fast-changing regulatory landscape in China.

 

Clemens Mohr- Director European Regulatory Affairs, MT PROMEDT CONSULTING GmbH

As an graduate engineer of Biomedical technology and professional education in electronics, Mr. Mohr is specialized in Active Medical Devices, particularly in x-ray and ultrasound diagnostic, endoscopy and medical imaging. He as over nineteen years’ experience in the Medical Device development, manufacturing and service, as well as Quality Assurance and Regulatory Affairs.

Before Mr. Mohr joined MT Promedt Consulting GmbH, he  worked several years as testing engineer and Lead Auditor in Japan for a German Notified Body.

At MT Promedt Consulting GmbH Mr. Mohr is the head of the European Authorized Representative department. As a registered Safety Officer under the German Medical Device Act, he has a deep knowledge about the European regulatory system and Medical Device Vigilance System.

 

 

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