Conference 2009

To help the industry grasp the growing demand for high-end medical devices, MEDTEC China Conference has revamped its structure this year by emphasizing industry’s regulations to help you upgrade your production know-how.

 

The Conference will even feature FDA officials and industry experts to share with you the regulatory updates on exporting medical devices to the US and the EU market as well as the latest development of regulatory issues in China.

 

 

Conference Program

Date Time Topic Speaker
8 Sep 2009 10:00-11:00 Indications of FDA's Critical Path for China's Regulatory Industry Mr. Chang Yong Heng
Deputy Director General, SFDA, China Center of Pharmaceutical International Exchange
11:00-11:15 Tea Break
11:15-12:15 Overview of the Shanghai Medical Device Industry and Advancement of Tapping Into International Markets Mr. Yi Cheng Dong
Secretary, SHFDA
12:15-13:45 Lunch
13:45-15:15 Panel Discussion on China and US Regulatory Issues

Mr. William M. Sutton
Deputy Director, Division of Small Manufacturers, International and Consumer Assistance, CDRH, USFDA

Mr. Yi Cheng Dong
Secretary, SHFDA

 

Mr. Yan Liang
Chairman, Shanghai Pudong Medical Device Trade Association

 

Mr. Chang Yong Heng
SFDA, China Center of Pharmaceutical International Exchange
15:15-15:30 Tea Break
15:30-16:30

Different Requirement Between ISO 13485 and 21 CFR 820 — Performed Validation in the US Regulatory Environment

 

Abstract:

  1. Validation Definition in by ISO
       13485 and FDA 21 CFR
        820 QSreg.
  2. Comparison Requirement
        Between ISO 13485 7.5.2
        and 21 CFR 820 .75: Document
        Requirement, Personal
        Qualification, Validation
        Cycle, Validation Output,
        Equipment, Scope,
        Software, Method
  3. Overview of Validation
        and Examples
  4. When is Validation Required
  5. Types of Validations
  6. Validation Requirements
  7. Phases of Validation
  8. US The Regulatory Focus-
        Warning Letters, Recalls and
        Part 11 Requirements

Mr. Scott Yu
China Healthcare Service Manager, FDA 510(k) Third Party Reviewer, EU Notified Body and CMDCAS Auditor, BSi Management System Certification (Beijing) Co. Ltd. Shanghai Branch
16:30-17:30

Introduction of EU Directives of Medical Device

 

Abstract:

  1. What Kind of Medical Device is
        Allowed to Launch to
        EU market?
  2. Applicable EU Directives to
        Medical Device
  3. Different Roles During the
        Course of the Product
        Launch in EU Market
  4. Assessment Route and
        Applicable Standards for MDD
  5. Brief Introduction of Update
        MDD Directive

Ms. Irene Chen
TÜV SÜD (China), Regional Manager of Medical Health Service
17:30 End
9 Sep 2009 10:00-11:05

Design Control Process


Abstract:

  1. Design Control related FDA
        Warning letter sample
  2. Design Planning Task
        breakdown
  3. Design input Scope and level
  4. CTS used in the design input
        in IVD products
  5. Design out – Product
        Specifications
  6. Design review
  7. Relationship with Design
        review to verification and
        validation
  8. Types of Design Verifications
  9. Orthopedics Products Design
        Verification Activities
  10. Design Validations
  11. Design Transfer
  12. Design Changes
  13. Design History File
  14. Design Process Summary

Mr. Scott Yu
China Healthcare Service Manager, FDA 510(k) Third Party Reviewer, EU Notified Body and CMDCAS Auditor, BSi Management System Certification (Beijing) Co. Ltd. Shanghai Branch

 

Ms. Sophia Huang
International Trade Department Manager, Daan Gene Co., Ltd.of Sun Yet-sen University

 

Mr. Johnson Shu
Director, Regulatory Compliance and Quality Assurance, Biomet Asia
11:05-11:20 Tea Break
11:20-12:20

IP Protection and Management for Medical Device Companies

Mr. Roy Zou
Senior Counsel, Hogan & Harton
12:20-13:45 Lunch
13:45-14:45

Risk Management for Implant Medical Device during Medical Device’s Total Product Life Cycle

 

Abstract:

  1. Some Basic Concepts of
        Implant Medical
        Device’s Management
  2. Medical Device’s Total
        Product Life
        Cycle Management
  3. Medical Device’s
        Risk Management
  4. International Trends for
        Medical Device’s
        Risk Management
  5. Total Product Life Cycle
        Risk Management for
        Implant Medical Device
  6. Risk Management Methods
        Used for Medical Device’s
        Total Product Life Cycle Risk

Mr. Mi Xianqiang
Associate Professor - Director, Institute of Medical Device Assessment and Management, College of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology
14:45-15:00 Tea Break
15:00-16:00

Design Controlling -
How to Design Products with Standards

 Ms. Wang Li
General Manager, China Region, MEDCERT
16:00-17:00

Supplier Quality Management

Mr. Liu Peng
Purchasing Director, Siemens Shanghai Medical Equipment Ltd.

17:00 End
10 Sep 2009 10:00-11:00

Overview of Regulatory Requirements

Mr. William M. Sutton
Deputy Director, Division of Small Manufacturers, International and Consumer Assistance, CDRH, USFDA
11:00-11:15 Tea Break
11:15-12:15

FDA Inspection and how the Shanghai FDA Post serve Chinese manufacturers

 Ms. Byungja Marciante
Investigator and Senior Assistant Director, USFDA Shanghai Post
12:15-13:45 Tea Break
13:45-16:00 (15:00-15:15 Tea Break)

Quality System Overview (Part 820)

Mr. Joseph Tartal
USFDA
16:00 End

No simultaneous interpretation will be provided in all conference sessions.
The organizers reserve the right to change the agenda without prior notice.

 

Conference Fee

  Early-Bird Discount
 (Deadline: 7 August)		 After 7 Aug or On-site
  RMB* HKD RMB* HKD
1 Day** 860 980 945 1,075
2 Days** 1,290 1,465 1,420 1,615
3 Days 1,720 1,955 1,895 2,155

 

*Inclusive of 6% invoice tax
**You can select the date for your conference attendance

 

Conference attendees can enjoy:

  1. Session materials on the registered days
  2. Tea breaks and lunch on the registered days
  3. A one-on-one meeting with USFDA officials (on first-come, first-served basis)
  4. Complimentary admission to the exhibition
  5. A copy of the show directory

 

"Meet the USFDA" Program
Get free, 20-minute personal advice from USFDA representatives at the "Meet the USFDA" Program. This service is exclusive to registered conference attendees on an appointment basis. Register for the Conference and arrange your face-to-face meeting with USFDA!

Meet these USFDA officials at the Program:

  1. Mr. William M. Sutton
  2. Mr. Joseph Tartal

 

Online registration is available! Register Now

 

For Conference Inquiries:
con-medtecchina@cancom.com
Tel.: +86 20 3761 6123