Chinesse medical device manufacturers to compete globally

HUAWEI is now absolutely a globally recognized brand name, and definitely a rising star in its cluster. Perhaps within 3-5 years, there will be a new 'LENOVO' or a new 'HUAWEI' in medical device industry as well.

Currently there are around 150.000 medical device manufacturers in China, but 90% of them can only achieve a yearly turnover between RMB 10-20 million. Most of them are producing medical disposables or small devices like thermometer, blood glucose meter, blood pressure monitor, or ECG monitor, many are on OEM basis.

In Chinese hospitals, for equipment like MRI, CT or endoscopy, some 90% are imported products. But the situation starts to change now, slowly. Since2013, we see Chinese manufacturers are releasing new products including ultra-sound scanner, MRI, CT and even PET-CT, as well as bio-chemical analyzer and etc, all under manufacturers' own R&D with self-owned intellectual property rights.

So far these Made in China products can't compete effectively in international market with those global leaders, but a long march to the global med tech market with Chinese domestic market as a starting point is logical and realistic. As long as the Chinese medical device manufacturers accumulate knowledge and experience in product and market development, strengthen the capability in research and innovation and with practical strategy and patience, they will obtain a decent market share not only in Chinese domestic market, but also in international medica device market.

Outsourcing Medical Devices Production to China

There are over 5,000 medical device manufacturers in China, mainly producing Class I, Class IIa & Class IIb devices, as well as certain categories of IVD product. Class III players are few though the number keeps increasing. To outsource the production of Class I / II devices or IVD to a qualified OEM manufacturer in China could be a cost saving solution to many of the EU device manufacturers.

All the Chinese medical device manufacturers must be registered to and licenses by SFDA, therefore it is very easy to check if the Chinese enterprise who is willing to work with you is a real producer or simply a trader.

We would recommend EU medical device manufacturers who outsource the production to China, that the perusal of technical files is a crucial and essential step before you reach any agreement with the OEM supplier. Otherwise it could lead to the result of failure to obtaining CE marks for the devices in EU.

If you have the time and money, a third party audit to the OEM supplier in China is recommendable.

Or perhaps the deployment of a neutral buying agent shall be considered, to make sure that quality procedures are properly followed up. The agent shall not just pay regular visits to the OEM’s facility, but should also bear the knowledge of ISO 13485 & CE requirements in mind.