What 2016 might bring for Chinese medical device regulation
07-Dec-15, Medical Device and Diagnostic Industry
The Chinese medical device market is maturing rapidly, and with it, so is its regulatory presence. Scott Bass, partner at Sidley Austin, knows this firsthand. Bass has lectured at Peking University on Good Manufacturing Practices (GMP) and with the US FDA has trained 100 inspectors on GMP for both drug and device inspection.
%20MD%20and%20DI.jpg "What 2016 might bring for Chinese medical device regulation (c) MD and DI")
Image: MD+DI
In a recent interview with MD+DI, Bass discussed the top trends on the horizon for the medical device market in China. Underlying many of these shifts is a move toward localization. For companies looking to enter the Chinese medical device industry, Bass suggests, "Take a good look at localization, because that is the trend for international companies . . . that is the way to enter with the greatest grace and success." One way to achieve this might be to work with a Chinese company through a joint venture.
Read full article on Bass's thoughts about:
- Shift Toward Localization to Encourage China's Home-Grown Device Industry
- Research Use Only Loophole Closing
- Imported Refurbished Products Will Be a No-No
- Local Bidding for Local Products
- More Inspection on the Way