Starting a Medtech Business in China? Remember, Patience Is a Virtue

August 24, 2012 – 9:28 am

A post titled “10 tips for doing medical device business in China” on the Medical Devices Group page on LinkedIn caught my eye as I was doing my morning rounds looking for medtech news. Sonia Zhao, who initiated the conversation, works with a consultancy in China that helps foreign medical manufacturers set up shop in the Middle Kingdom, so there is a soupçon of self-promotion, but the conversation has taken some interesting turns. Not surprisingly, regulatory matters and in-country partnerships come up frequently. Successful outcomes in both domains require a healthy dose of patience.

At the top of her tip sheet, Zhao writes “If you have CE or FDA approval, you shall not have regulatory difficulties.” Perhaps, but be prepared to spend a lot of time waiting. “I’ve been involved in the approval of two CE and FDA cleared products in China, and while both ultimately were cleared by SFDA, the process for each was 3+ years,” comments Daniel L. Mooradian, a medtech executive in Minnesota, USA. “I am sure that things would have been even more difficult (if not impossible) had we not had CE and FDA clearance and clinical data, but the regulatory process in China requires persistence, patience and active management by your regulatory colleagues.”

Finding a reliable, trustworthy partner is also essential to building a successful medtech business in China, notes Zhao. “I have worked with several medical device distributors and found that some of them will [exaggerate their earnings] to get a better image for international companies.” When it comes to finding a partner on the ground, Dave Speck, who works in international sales in Ohio, USA, advises taking the “time to do it right. It will pay off in the future. There are very few shortcuts to establishing a viable and successful business in China.”

I have pasted Zhao’s initial 10 tips below. Later in the conversation thread she elaborates further on these points. To view that and the various comments her list has inspired, go to the Medical Devices Group on LinkedIn.

Sonia Zhao

10 Tips for doing medical device business in China

• Regulatory – if you have CE or FDA approvals you shall not have regulatory difficulties. However, the registration classification and procedure will be different here.
• Market Volume – how big can be the market for your product?
• Competitors – it is very essential for you to know who are in the market at present and how well your product is compared with theirs.
• Policy – whether there is the policy for selling the special field of products can help you make right promotion strategies.
• Reimbursement – whether your product is in the reimbursement list of all the hospitals is a key point for large sales volume.
• Cooperation mode – how to choose the right cooperation mode can be a question for most of the manufacturers.
• Partner – whether the partner has the ability as they told you?
• Import – whether there is some policy for prohibiting your product importing into Chinese market and how much is the import tax?
• Promotion – how can this product be promoted in Chinese market? Through which channel it can be known by more people?
• Procedures – how can everything goes on the right way and how can this be controlled?

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  1. One Response to “Starting a Medtech Business in China? Remember, Patience Is a Virtue”

  2. Norbert;
    I find this interesting that there is no mention of the issues with Intellectual Property. First have a strategy to decide which technology to introduce into China realizing that it will be copied. Second, submission of your IP in China is very important before proceeding to the registration phase.

    And last, there are a lot of service companies that claim submission success at the SFDA, however most promise great timelines, few deliver as they are overwhelmed by client requests and require a learning curve for your product area. If at all possible, hire a regulatory expert full time as an employee that oversees the process or prepares the submissions. The pay will be higher than expected but worth it to make sure approvals go smoothly.

    After >100 submissions to SFDA, they are in a state of constant change both organization structure and requirements. For a US Company become a member of your industry lobbyst group, such as AdvaMed (MD&D) that can help with submission difficulties through their connections with the State Department and MOH/SFDA in China.

    Karen Thomas
    MedOutcomes, LLC

    By Karen Thomas on Sep 10, 2012

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