May 2, 2018
2-3 PM EST
Registration is Closed
China has become the 2nd largest med-tech market in the world. Chinese government plans to spend $125 million in healthcare market over the next three years. President Xi’s initiative from “Made in China” to “Innovate in China” will drive domestic and foreign medical device/ IVD companies’ growth in the premium market. But there are also challenges along the road to success: dynamic regulatory changes, reimbursement and distribution differences.
In the first quarter of 2018, before the disappearance of CFDA name, a few major regulations been released:
- Acceptance of overseas clinical data accelerating approval of foreign med-tech products;
- Updating 200 + standards to be more in line with international ones;
- Marketing legal entity separate from the manufacturing entity piloted in Shanghai free trade zone
- 3D printed medical device draft guidelines propelling China to be the leader of orthopedic and dental applications.
- Most exciting news is Hainan special zone policies. Hainan, the China Hawaii, has become the first independent province for imported medical device approval to encourage international health travelers and expedite local economic development.
This webinar, presented by Grace Fu Palma, CEO of China Med Device, LLC, will highlight following areas:
- Why do you choose China: the unique characteristics of China medical device market
- What is new and what you can expect: the changing landscape of med-tech market under key healthcare initiatives
- What is new in CFDA in 2018: key registration pathways, type testing, CER and clinical trial, etc.
- How to sell your products: key factors for successful medical device commercialization in China
Time will be allotted for Q&A.
Registration is Closed
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. Our management team has 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ Chinese and western companies’ success.