November 08, 2018 - November 08, 2018
Date: 8 November 2018
Location: Amsterdam Area
Language: Presentations will be in English
Cost: Regular: € 875.-
Early bird: € 800.- (until 1 October 2018)
Since the Chinese Medical Device Regulation overhaul in 2014, the market has witnessed countless updates in its regulatory rules, technical guidance, and standards. And the recent governmental reorganization where the formal regulatory body, CFDA (China Food & Drug Administration), is integrated into the new CNDA (China National Drug Administration), seems to herald more changes into the current regulatory framework.
New requirements on clinical evidence, China Agent, overseas inspections etc. bring forth both opportunities and challenges for the foreign medical device manufacturers.
This training will give an overview of the Chinese medical device regulatory landscape and provide details which are essential for a successful product registration in China. New regulatory requirements such as classification, China Agent, vigilance, clinical evaluation and clinical trial etc. will be included in the training as well.
- Introduction to Chinese regulatory & regulations overview
- Timeline, planning, and budgeting for CFDA registration;
- Registration routes;
- Submission file;
- Clinical evaluation and clinical trial;
- In-China lab testing;
- China Agent;
- Dos and Don’ts with CFDA;
- Questions & Answers;
- Evaluation of the Course and Closing.
During the course case studies are used to practice the learnings.
- Understand the current regulatory framework in China;
- Learn what is needed for typical planning and budgeting for product registration in China;
- Learn to classify your medical device and select the appropriate market access route;
- Learn the high-level submission file requirements;
- Learn the requirements of clinical evidence;
- Understand the roles and responsibilities of different stakeholders (e.g. China Agent, CFDA, distributor etc.) in relation to the foreign manufacturer during and after the registration.
Who should attend
The foreign manufacturer who has no or limited CFDA experience.