To understand about China's SFDA regulations relating to an enforcement of device rules,laws and legal standards in market.

Objectives of this course:

To understand about China’s SFDA regulations relating to an enforcement of medical device rules, laws and legal standards in an international market

To learn about strategies to overcome regulatory hurdles with an aim to enhance products success in a Chinese market

Course of Content:

1.      market analysis in China

2.      global regulatory environment

3.      regulatory framework in China

a)      classification

b)      conformity assessment

c)      quality system and GMP

d)     vigilance system

4.      Character and trend of SFDA regulation

5.      Recent updated of SFDA regulation

6.      Challenge and Hurdles of SFDA registration

a)      Standard system and manufacturer standard

b)      Testing of the Standard

c)      Clinical trial

d)     Renewal registration

e)      GMP requirements

7.      Practice of SFDA regulation

8.     Strategy of SFDA regulation compliance

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Date:        20 April 2012

Time:        09:30-17:30

Organizer:   Asia Regulatory Professional Association

Shenzhen Hlongmed Biotech Co., Ltd.

Venue:       Fubang International Hotel

Address:     Cross of Qianhai Road and Xuefu Road, Nanshan District, Shenzhen

Fee:         MRB 2800  person

Language:   English

Date:       20 April 2012 Time:        09:30-17:30 Organizer:   Asia Regulatory Professional Association Shenzhen Hlongmed Biotech Co., Ltd. Venue:      Fubang International Hotel Address:     Cross of Qianhai Road and Xuefu Road, Nanshan District, Shenzhen Fee:         MRB 2800  person Language:   English

Enquiry:

Tel: +86-755-33390385

Shenzhen Hlongmed Biotech Co.,Ltd.

Medical Device Consulting Service  Tel:       +86-755-33390385  Fax:      +86-755-33390383 

Website:  http://www.hlongmed.com

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Trainer: Mr. Long Yang

Chief Operation Officer of Shenzhen Hlongmed Bio-tech Co., Ltd.

Mr. Long Yang holds a Master Degree of Biomedical Engineering from the Sichuan University

Over 10 years of management experience in the medical devices industry, management representative and Director of QA and RA in Mindray, project manager and R&D manager in Livzon Group.

In the medical devices industry, he has broad and rich experience from active to non-active IVD and medical devices, from non-sterile to sterile, from low risk to high risk, from little to large equipment, and in whole process from R&D, supplier chain, manufacturing, market clearance, customer complaint and Vigilance system.

As a core team member of Merging and Acquisition of Medical Device Company in Global market and China in Mindray. He is also experienced in Merging and Acquisition of Global and Chinese Medical Industrial.

Externally, he plays an active role in many forums as He also has been acting as a Keynote speaker. He has been acting as a vice Chairman of Shenzhen Association of Medical devices. A member of secretariat and a part-time member of WG1&3 in AHWP and a member of Expert Panel for Guangdong Provincial Government Quality Award and Shenzhen Mayor Quality Award, and Vice-Chairman of Shenzhen Association for Quality.

Training Course (Chinese SFDA Registration Regulatory Course Medical Device regulations in China)