3 min reading time

After reading Urs Mattes‘ 31-page Chinese Medtech report at https://medgroup.biz/chinese, I think foreign company success heavily favors the largest companies with the longest time frames.

Is that a reasonable conclusion based on your experience?

This direct statement struck me:
One would be well advised not to believe certain consultants and local distributors who claim that the market in China is huge. The potential is huge but not the market.

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:
• In most medtech segments the Chinese market is between 2 and 10 per cent of the global market. Equipment fares better than implantable medical devices, the latter being not (or only partially) eligible for reimbursement at present.

• 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!

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Thanks, Gali, yes. Everything I post is open to share.

Jeremy Bocknek
Entrepreneur in the Animal Welfare Medical Technology Space – Looking for opportunities, partnerships and investment
Ahh but the animal space is good.

Gali Halpern Wienerman
Principal – Ventures, Healthcare lead at Accenture
Joe Hage – really liked your analysis and questions on this post. We are dealing with a similar challenge regarding potential vs actual in China but for the younger startup ecosystem. Here in Israel it is branded as “investments” when in essence it is public-private partnerships trying to convince startups to open a subsidiary in China. It is very confusing and as you can imagine the weekly delegations from China wanting to meet pre-market Life sciences startups are difficult to accommodate especially if you take into account our measly 9 million vs their 1.404 billion population… would love to share this in our network for those who are not in this group if you don’t mind.

Arthur Brandwood
Medical devices and IVD regulatory expert with a global perspective
The thing is it’s a movable feast in China. CFDA introduced the Order 650 as a first attempt to get a tighter control on regulation. They have been busily fine tuning it – or filling in the blanks (take your pick) ever since. This is the way it works in China, rapid consultations and then rapid changes with short implementation times.

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.
Expect to see implementation in the new year.
See http://brandwoodbiomedical.com/china-draft-regulations-abolish-type-testing/ for more details