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Is that a reasonable conclusion based on your experience?
This direct statement struck me:
Most international medtech companies… have a Japanese subsidiary… larger than their Chinese operation in terms of turnover, despite the much smaller population in Japan.
From Urs’ report:
• Foreign medtech players have to learn to adjust to high volumes and low prices while domestic companies have to upgrade their products in order to compete.
• One of the major hurdles to enter the Chinese medtech market is the new regulatory rules under Order 650 which require clinical trials for innovative products. Registering a medtech product in China has become expensive and time-consuming because CFDA fees, testing fees and clinical trial fees for an innovative product are high. Clinical studies for an innovative product cost between CNY 7 to 10 million (USD 1 to 1.5 million) and it takes a total of 3 to 5 years to obtain the license.
Urs, thanks for letting me give this out to the group: https://medgroup.biz/chinese
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It’s Election Day in the US. Go vote!
Gali Halpern Wienerman
There’s some potentially good news on the horizon. On the last day of October CFDA published draft changes to Order 650 which promise to abolish Type Testing, accept more international clinical data and speed up clinical trial approvals when they are required in China.
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