“I can’t tell you how many companies said we just didn’t bother protecting in China because they don’t care. They’ll copy anyway,” said Landon Lack at this year’s 10x Medical Device Conference.

His entire talk here: https://medgroup.biz/Landon

“You have to protect your IP in China. If you don’t protect your IP in China, no one’s going to want to partner with you.”

Other takeaways:
• 1.3 billion people doesn’t mean the market’s big enough for your device. What’s in the market, where’s it going, how strong are foreign and domestic competitors?

• Some products may fetch a premium; others will compete with most-favored nation pricing. Reimbursement is not a factor; everything is private pay.

• If there isn’t an established hospital access code, the hospital can’t pass the cost on to the patient, and won’t touch your product.

• Landon advises if you’ll have to do a clinical trial, don’t enter China. It will take too long and cost too much.

• In the past, a product imported from the US was perceived to have higher quality. The landscape has changed. China has been emphasizing domestic quality, so make an evaluation whether to enter as a domestic Chinese product or as an import. There are pros and cons to both.

• You’ll need a partner. Just don’t make that partner your distributor. He explains why in the video.

So if you need help in the Chinese market, call Landon. The link for his video again at https://medgroup.biz/Landon

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How to prepare for MDR: https://medgroup.biz/MDR-prep

Tobias Schreiegg (QA/RA Director, Siemens Healthcare) and Dorota Johansson (Clinical and Research Director, Bactiguard) on:

• The impact MDR will have on both organizations and the industry
• How they are preparing
• Best practices for communicating the reg changes to your organization

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Jon’s CAPA webinar is today: https://medgroup.biz/capa – replay and slides to all who register

Rumina Akther
Experienced Marketeer | Lifestyle Blogger
Thanks for sharing- great to see how they are preparing for the new regulations!

Tom Ackrill
Business Development Manager at ITL Group (a Gooch & Housego Company)
Interesting article – and certainly an interesting market to be getting into. ITL has been working in China for about ten years now via our facility in Shanghai and it’s definitely getting harder and more costly to get a device into China.

Our clients that we’ve helped to handhold through the CFDA process certainly appreciate the help – clinical trials etc can add huge amounts of cost to the program but if the potential revenue is there, and you can plan your business early enough that you can allow for the couple of years necessary to get approvals then it’s a very lucrative market in our experience.

Doug Sparks
Chief Technology Officer at Hanking Electronics
Using a local (Chinese) IP firm, even if its through you US patent attorney, is key to protecting your technology and business in China. If you have Chinese patents you can protect your IP in China, and it increases your probability of success there.

Katherine Gordon
Portfolio Director at Pharma IQ
Thanks for sharing the link about the MDR conference!
“How to prepare for MDR: https://medgroup.biz/MDR-prep”

Johnny Chan
Product Developer Specialized in Medical Devices
It is a state strategy to use regulatory to fence homegrown companies from foreign competitions and force international competitors to transfer their knowledge and know-how to these Chinese partners. So the real challenge is not developing business in China but to make sure that your Chinese partner will never be capable of competing against you some days in future.

Suresh Raut
SEO | Social Media | Digital Marketing | Link Building | Bookmarking
Nice