Registration
Course - Introduction to Medical Device Regulation and Registration in Taiwan
Oct 18, 2011
Stockholm,Sweden
Taiwan is a fast growing market for medical devices with great potential and plenty of opportunities. However Taiwan's medical device regulation is bureaucratic and opaque. Regulations are broadly based on a US/Japanese risk-based approach, but the process can be unpredictable. This course will give you detailed information on the Taiwan medical device regulation and registration process, and the knowledge on management of quality system documentation approval, 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 Taiwan.
Preliminary program
09.30-10.00 Registration and coffee
10.00-10.30 Introduction
10.30-12.00 Market overview
-Regulators
-Regulatory framework and requirements
12.00-13.00 Lunch
13.00-15.00 QSD approval
Product registration
15.00-15.30 Coffee
15.30-16.00 Product registration (Cont.)
License modification and re-registration
16.00-16.30 Clinical trials
16.30-17.00 Questions and discussion
Speaker: Dr. Lian Zhang, Sr. Consultant
Topics covered:
• Regulations
• General requirements
• Management of quality system documentation approval
• Requirements for clinical data
• Registration process
• Common pitfalls, and
• Modification of license
Who should attend:
- Regulatory managers and specialists
- QA managers
- Marketing managers
- Project leaders
- Clinical study managers / associates
- CEOs
Date and time Tuesday: October 18, 2011, 9:30 – 17:00
Location: Synergus AB, Svärdvägen 19, 182 33 Danderyd/Stockholm
Registration: info@synergus.com, please indicate clearly the course name and date
Last day of registration: October 11, 2011. Limited number of participants.
Course fee: SEK 4 000 excl. VAT/MOMS (Morning coffee, lunch and afternoon coffee are included; VAT/MOMS is excluded).Please indicate special considerations on 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.