For many start-ups entering the Chinese market can be a significant hurdle. We’ve mentored various life science and technology start-ups through this process. Most recently, Wei has completed mentoring an exciting medical device start-up based in Germany.
To help these young companies through the process we’ve put together the 10 most important things to consider before beginning this process.
1. Which organisation handles the certification for medical products?
It’s the National Medical Products Administration (NMPA). You can visit their website by clicking here. (http://english.nmpa.gov.cn)
2. Does our start-up need to undertake clinical studies based in China?
The answer to this question isn’t as clear cut as it might seem. There’s a variety of other questions to answer first. Firstly, is your product classified as a “medical product” in China? For example, it’s very likely that a rehabilitation device is classified as medical equipment in Europe but not in China. Secondly, did you know there’s an exemption catalogue with medical devices that don’t need to undertake clinical trials locally in China if you have done the trials somewhere else already? This exemption catalogue includes a total of 1003 types of medical devices and 416 types of IVD products.
3. How can we initiate our own clinical studies in China?
You have decided on undertaking clinical studies in China – but where is the best place to start? The most straightforward approach is to identify the KOL in your field. Try to start your clinical trial with their team. Clinical trials – necessary or not – will better prove the product to local patients and healthcare providers. The studies with the KOL group will raise the credibility of your product. Later, your KOL may act as an advocate for your product. At the heart of China’s healthcare is a medical insurance catalog. This contains the range of products which can be covered by the state health insurance. Clinical trials in China will mean you’ll likely be viewed more favourably by stakeholders and have your products listed in this catalog. Ultimately, a product listing will be the main driving force behind increasing your brand visibility and trust with patients and healthcare providers alike across China.
4. Do we need a Chinese subsidiary?
This depends on your funding situation. Chinese subsidiaries can help you in many ways. A Chinese subsidiary is crucial if you would like to register your product as a domestic product. This is likely to bring a more successful business opportunity and wider market access.
5. Do we need legal protection insurance or similar?
It’s difficult to cover your China activities from abroad. However, it’s important to make sure that your own subsidiary or local partner has all the relevant insurance in place.
6. Shall we contact the health insurance company at an early stage?
The major health insurance provider in China is the state healthcare insurance. The Chinese healthcare system is dominated by the public sector (at 90%). The challenge is that it can take a long time to enter this system. It’s also clear that the intention of the government is to encourage the system to lean towards the domestic suppliers. You should consider revisiting this only once your product has been registered successfully in China.
7. How can a Chinese distributor be chosen?
The answer to this question depends on what you need from your distributor. Choose your distributor based on their skill set. For example, do you need your distributor to assist with the product registration? Should they be able to assist with your clinical trials or only distribute the product? In general, you need to find distributors who are established, experienced and motivated. They should be committed to introducing a new product from a foreign supplier into the Chinese market. A scattergun approach will not help you find good distributors.
8. Is there any way to speed up product registration?
There’s no official way to speed up the product registration as far as I know. An experienced agency or CDMO company will help ensure the product registration process is as efficient as possible.
9. Is there a way to accelerate the clinical trial process in China?
Does your product treat a life threatening disease? Is there no other alternative available on the market? If your product is unique and treats a life threatening disease, look into fast tracking it via Boao Hope City. Take a look at our resources page to find out more about the Boao Hope City program.
10. Can we protect our name, logo and overall brand in China?
Yes. Be sure that the name isn’t already registered – at least for your specific market segment. It’s recommended that the logo, the name in English and the name in Chinese are registered separately. Launching your medical business in China can be challenging, however we’re here to make the process as smooth as possible whilst optimising your chances of business success.