ARTICLE SUMMARY:
Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CEOs and advisers share how improvements in the regulatory and IP landscape make finding a reliable Chinese partner easier, while also highlighting how to avoid potential pitfalls along the way.
The last few years have brought a series of wide-reaching changes to the medtech landscape in China, some of which have been driven by that country’s economic situation, while others have been the result of regulatory changes by the NMPA (National Medical Products Administration, the Chinese equivalent to the FDA). The economic shifts have led to restrictions on money leaving China, which has largely turned off the spigot of Chinese investment capital available to companies outside the country. But although that trend has limited Chinese external involvement in medtech, the regulatory shifts provide opportunities for companies from outside China to more easily gain access to the internal Chinese market, a move triggered by China’s implicit recognition that it was unable to provide the kind of needed medical technology on its own from native manufacturers.
The timing of these regulatory changes is also propitious as they are occurring as regulatory confusion reigns in Europe as a result of the implementation of the new Medical Device Regulation (MDR). This lack of clarity surrounding the CE mark process has caused many US and European companies to forego the widespread previous strategy of initially commercializing in Europe, which had been valuable under the previous European regulatory regimen. Now instead, many companies are looking to the US first, with some also exploring early commercialization in Asia, with China being the most attractive national market. In that sense, easing access requirements to the Chinese market could not be coming at a better time.
