Registration
Course - Introduction to Medical Device Regulation and Registration in China.
Oct 13, 2011
Stockholm,Sweden
Introduction of the event China is a fast growing market for medical devices with great potential and plenty of opportunities. However the regulation system for medical devices in China is complex, not transparent or consistent. It is also important to understand the culture and the environment in which the regulations are interpreted. This course will give you detailed information on the Chinese medical device regulation and registration process, and the knowledge on management of "Product Registration Standard”, type-testing, clinical study and registration dossier, as well as labeling. It is also possible to have discussion on your specific questions regarding your product registration in China.
Preliminary program
09.30-10.00-Registration and coffee
10.00-10.30-Introduction
10.30-12.00-Chinese regulators
Regulatory framework and requirements
12.00-13.00-Lunch
13.00-15.00-Regulatory framework and requirements (Cont.)
-Product registration
-Product registration standard and type-testing
15.00-15.30-Coffee
15.30-16.00-Clinical trials in China
16.00-16.30-Culture and communication considerations
16.30-17.00-Questions and discussion
Speaker: Dr. Lian Zhang, Sr. Consultant
Topics covered:
• Regulations
• General requirements
• Management of registered product standard and type-testing
• Requirements for clinical data
• Application process
• Common pitfalls
• Modification of license, and
• Some culture and communication issues
Who should attend:
- Regulatory managers and specialists
- QA managers
- Marketing managers
- Project leaders
- Clinical study managers / associates
- CEOs
Date and time: Thursday, October 13, 2011, 9:30 – 17:00
Location: Synergus AB, Svärdvägen 19, 182 33 Danderyd/Stockholm
Registration: Tel. +46 (0)8-544 767 50, Email: info@synergus.com
Last day of Registration: October 7, 2011. Limited number of participants. Please indicate clearly the course name and date.
Course fee: SEK 4 000 excl. VAT/MOMS (Morning coffee, lunch and afternoon coffee are included) Please indicate special considerations regarding meals. Invoice will be sent upon confirmation of registration.
Cancellation policy: Cancellation of registration prior to the commencement of the event:
- 21–7 days, 25 % of the fee
- 7 days, full fee
You may replace one participant with another person if you inform us no later than 3 days before the event. Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances full course fees will be refunded.