Presentations on latest regulatory updates and technical requirements for medical device are available upon request

This workshop was held in Milan, Italy on 23^rd April 2015. More than 30 manufacturers of medical devices or in vitro diagnostic regents have attended the event. The following presentations are available upon request:

1. Mr. Edwin Wen, Medical Device Management in China and Latest Regulatory Updates;
2. Mr. Michael Petersen, Practical know-how on medical devices' market entry and approval process;

Please contact Michael@cirs-group.com if you would like to obtain a copy of any of the above presentations.

The purpose of the workshop is to facilitate an in-depth discussion of regulatory insights among China, Europe and U.S.A. The workshop aims to foster awareness of medical devices' market and approval process in China; provide a deeper understanding of the ISO approach applied to medical devices; gain practical advice on successful biocompatibility submissions in Europe; help understand FDA requirements and expectations for biocompatibility testing and evaluation compare to European requirements.

• Date, Time and Location
• Agenda
• Registration
• Comments
• Contact Us

Date, Time and Location:
This meeting will be held 23^rd of April, 2015, beginning at 9:30 a.m. at the following location:
Michelangelo Hotel
Grand Ballroom
Piazza Luigi di Savoia, 6 – 20123 Milan, Italy
Tel: +39 0267551
Fax: +39 026694232

Agenda

Time	Topic	Speaker/Panelist
9:30 – 9:50	Welcome and introduction
9:50 – 10:30	The ISO approach to internationalization	Albrecht Poth - Eurofins Scientific Director Medical Device Testing in Eurofins. He has gained estimable skills and expertise as Technical Director, Senior Manger in Regulatory Affairs, Study Director in leading companies of the industry. Before joining Eurofins Group he was Deputy Managing Director and ScientificAdvisor for Harlan CRS Cytotest Cell Research. He is an active and long date member of various international groups. He is convenor of the expert group of the ISO/TC 194 (WG6) and Chairman of ISO Technical Committee 194 “Biological Evaluation of medical devices”.
10:30 – 11:15	Medical devices management in China and latest regulatory updates	Edwin Wen – CIRS Manager of Strategic Operating Division & Medical Device Legislation Compliance Department of CIRS (Chemical Inspection & Regulation Service) in China. Has an extensive background in China medical device regulatory activities by developing compliance procedures for medical device registration in CFDA, compliance procedures for the entry of medical device and formulated technical methods for the regulatory risk management in China.
11:15 – 11:45	Coffee break
11:45 – 12:40	Practical know-how on medical devices' market entry and approval process	Michael Petersen – CIRS Business Developer of Medical Device Legislation Compliance Department of CIRS (Chemical Inspection & Regulation Service) in China. He is working on the medical device market expansion, regulatory affairs extension and help foreign medical device enterprise enter the China market including also tracking and update of CFDA medical device regulations.
12:40 – 13:10	Question & Answer session
13:10 – 14:00	Networking lunch
14:00 – 14:40	The EU medical device directive: state of art and expectations	Enrico Perfler – Atricath CEO ofAtricath, Italian start-up company developing an innovative ablation catheter for atrial fibrillation treatment. He previously was Director of Medical Device Technology at Eudax, a contract research organization focused on early stage project development for medical device and parmaceutical companies. He is also contract professor at the University of Pavia, faculty of Engineering and he participates actively to various national and international technical working groups.
14:40 – 15:20	Notified Body perspective	Paolo Dentis – Eurofins Certification Manager of the Notified Body 0477. He has a solid background in classification and certification procedures for medical devices. His expertise encompasses different regulatory framework in particular Directive 93/42/EEC on Medical Devices, Directive 2006/42/EC on machinery and Directive 89/686/EEC on Personal Protective Equipment (PPE).
15:20 – 16:10	FDA requirements and expectations for biocompatibility and evaluation compared to Europe	Elena Aleotti – Sorin Group RegulatoryAffairs Specialist at Sorin Group. Dealing with CE marking and FDAsubmissions of medical devices, she is charge of creation, review and maintenance of Technical Files. Following all product lifecycle, she cooperates with new product development teams, advising on risk management, product safety and relevant regulatory affairs standards and guidelines for medical devices.
16:10- 16:40	Open forum, questions, concerns, clarifications	All speakers
16:40- 16:45	Conclusions

Registration to Attend the Workshop:
To register for the public workshop, please visit the following Web site:http://www.eurofins.it/media/10760065/medical_devices_workshop_regulatory_insights_april2015.pdf
Streaming Live Audiocast
We are pretty sorry that live audiocast is not available for this workshop.

Comments
CIRS is holding this public workshop to focus on its first part on the international testing approach of medical devices and challenging regulatory environment in China. The second part will give highlight on two different perspectives comparing the EU Medical Devices Directive and FDA requirements and expectations for biocompatibility testing: Notified Body and expert consultants from the industry. This workshop represents a unique opportunity for participants to benefit from the significant experience of the most relevant experts of the industry regarding the compliance environment affecting medical devices companies with main focus on the Chinese, European and U.S. market.
Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to Michael@cirs-group.com or written comments to the medical device department of CIRS, 11/F.,Buliding 1,Dongguan Hi-Tech Park,228 Qiuyi Road, 310052.

Contact Us
For questions regarding workshop content please contact:
Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
11/F.,Buliding 1,Dongguan Hi-Tech Park,228 Qiuyi Road, 310052.
Email: Edwin.wen@cirs-group.com

Ms. Elaine Lyu
Elaine@cirs-group.com
11/F.,Buliding 1,Dongguan Hi-Tech Park,228 Qiuyi Road, 310052.

If you need special accommodations due to a disability, please contact Michael Petersen (see Contact Persons), +86 571 8720 6559, Michael@cirs-group.com, no later than April 10, 2015.