China and Japan each present their own unique set of challenges pertaining to medical device development. This is especially true for foreign manufacturers as they strive to stay abreast of the quickly changing medical device regulations and product approval processes in these sometimes tough-to-navigate geographies.
Join NAMSA’s regulatory experts on July 20, 2017, Lei Yang, Medical Research Manager – China, and Kei Yoshikawa, Medical Research Manager – Japan, as they present information that will assist attendees to:
- Understand the history of medical device regulations in China and Japan
- Become familiar with the most recent and significant regulatory shifts in China and Japan, including:
- New product classifications
- Updated registration categories
- The process of category registration, and information on how to successfully prepare for each
- Device approval process, including estimated approval periods
- Identify the best-fit submission framework to reduce development costs and expedite market introduction timelines
- Understand the licenses that are required to sell and/or manufacture in China and Japan
- Identify the appropriate development strategy for optimal development results
Kei Yoshikawa, Medical Research Manager, NAMSA
Kei Yoshikawa has been in the medical regulatory industry for over 15 years. During that time she has prepared and submitted regulatory applications for medical devices to Japan’s MHLW approvals and notified body accreditations, as well as negotiated with reviewing bodies in Japan (e.g. PMDA, notified body) for inquiry responses. Ms. Yoshikawa has also prepared and attended PMDA consultation meetings to negotiate products’ submission strategies and reviewed and input Japan regulatory assessments into designing development plans. She also has experience with preparing and submitting MHLW reimbursement applications for medical devices. Ms. Yoshikawa has written and edited JIS (Japan Industrial Standard) T 3323 Pressure Transducers.
Lei Yang, Medical Research Manager, NAMSA
Lei Yang has worked in the regulatory field for the medical device industry in China for eight years. She has planned and executed the regulatory strategy for the China medical device market. Ms. Yang has managed project timelines to ensure the timeliness of CFDA registration as well as other certificates that are needed. She has also drafted qualified technical documents to compile product standard. Ms. Yang has experience with in vitro diagnostic devices, neurovascular and radiology/imaging.
Who Should Attend?
|Department Heads/Senior Professionals working within:
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines-consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality-to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.
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