China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.
The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.
This presentation provides an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.
This audio conference covers:
- Healthcare regulators for medical device and IVDs in China
- Key regulations for device and IVD registration
- The registration process for importing medical devices and IVDs
- Preparing registration documents to import devices and IVDs
About the speaker:
Janice Ma is the Operations Director and Cofounder of ChinaGate Ltd., a leading pharmaceutical, medical device and IVD consulting company. She has extensive experience in project management, regulatory affairs, patents and trademark registration in the pharmaceutical and medical device sectors in China.
Prior to cofounding ChinaGate, Ms. Ma worked with two of the top 10 multinational pharmaceutical companies as Regulatory Manager and Project Manager, achieving success on development of numerous ethical drugs, biological products and OTC drugs in China.
Since cofounding ChinaGate in 2002, Ms. Ma has led the team to successfully obtaining more than 50 import medical device registration licenses. Working cooperatively with UL since 2005, she has also successfully helped Chinese medical device manufacturers obtain several USA FDA 510k approvals. She has cross-experiences and is familiar with regulatory requirements and regulations of China SFDA, USA FDA and European CE approval.
Who should attend?
- Senior Management
- Regulatory Affairs
- Chief Engineers
- QA Managers
- Design Engineers
- Marketing Managers
This audio conference is classified as General Interest.
ForeignExchange Translations provides specialized Chinese translation services to medical device and pharmaceutical companies.