MedTech Events

   

MedTech Institute | Bridging Regulatory Hurdles in the Growing Asia-Pacific Market

4/19/12 (TH) 9:00am-3:00pm

Bausch + Lomb Global Eye Health Center, 1400 N. Goodman Street, Area 67 A&B Training Room, Rochester, NY

The Asia Pacific (APAC) medical devices market is estimated at $55 billion--about one quarter of the global medical devices market. Regulatory policies are becoming more stringent in most APAC countries to facilitate the growth of the medical devices market, which is projected to grow more than 10 percent over the next three years. APAC is one of the fastest growing health markets in the world, and a tremendous opportunity for medical device spending

This workshop will address regulatory compliance and strategies for bringing products to the Asia Pacific market.

Program overview:

Part 1: Regulatory Considerations and Strategies for China

Presented by: Carestream Health, Inc.

In order to place a medical device or diagnostic product on market in China, manufacturers must conform to applicable Chinese standards, comply with Chinese product testing requirements, receive China Compulsory Certification (CCC) from the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and register their products with the State or Provincial Food and Drug Administration. This presentation will cover the initial registration and renewal processes, product testing requirements, using State vs. Provincial regulatory agencies and contract manufacturing.

Part 2: Industry Panel: China

Presented by: Carestream Health, Inc. and Welch Allyn

Industry insights from leading device and diagnostics manufacturers.

Part 3: Regulatory Compliance in Asia

Presented by: Pacific Bridge Medical

A review of the regulatory challenges manufacturers face when trying to register and maintain registration of medical devices in Asia.  The presentation will cover both the current regulatory environment in Asia and anticipated changes over the next few years.  The focus will be on countries other than China and will include an opportunity for Q&A. 

Part 4: Industry Panel: Japan

Presented by: Bausch + Lomb, ConMed Corporation

Industry insights from leading device and diagnostics manufacturers.

Featuring:

Ames Gross, President, Pacific Bridge Medical

Ames Gross is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named him one of the top 100 executives in the medical business. Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia.

Expert Panelists:

  • Jessie Verna, Director, Regulatory Affairs, ConMed Corporation
  • Lisa Anderson, RA Manager, ConMed Corporation
  • Xiaoping Li, China Compliance Director, Carestream Health, Inc.
  • Kevin Crossen, Director, Regulatory Affairs, Welch Allyn
  • Jennifer Murray, Manager, Global Regulatory Affiars, Bausch+Lomb
  • Helen Sun, Associate Director, Regulatory Affairs, Bausch+Lomb

 

Sponsored By:

 

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