There are considerable gaps in product innovation and quality control of medical devices between China and advanced world standard. Although recently some medical device enterprises in China have undertaken some manufacturing tasks from developed countries and improved their manufacturing technology to some extent, they still lack sufficient ability in materials and process. Now, high value-added medical devices for diagnosis and treatment in China still rely heavily on imported technology. According to the prospective database, from January to November of 2016, the export amount of medical instruments and devices in China reached 8.4 billion USD, with a YOY drop of 0.54%, among which the export amount was 860 million USD in November.

At present, medical device products in China remain a serious lack of quality compliance and stability. During manufacturing of medical devices, there is a “difference per batch” which is frequently encountered in China among products in different batches. Besides, homogenization competition and competitive means like irrational price also directly influence the export of medical devices in China.

The current competitive landscape demands prompt change for these problems. Enterprises must develop their internationalized vision, foster brand awareness, adhere to related quality standards, pursue the international standard in technology, keep up with the advanced figures, persist in integrity management and operate by the rules. They must take product quality as their chief goal and work hard on products, pricing, channels and marketing.