The Chinese Market (SFDA)

The Chinese market is an attractive market, especially for future development. It recorded the strongest growth in the world. In 2006 it was quoted at U.S. $ 4 billion and in 2011 it is expected to reach U.S. $ 9 billion. Also in 2006, the number of Italian manufacturers of new products introduced for the first time into the Chinese market, was 354 out of a total of 13,860.

Even in China, before placing a medical device on its territory, you must obtain the "certification" of the product by the SFDA. Depending on the class of the medical device, the registration process follows a more or less complex path. They range from a documentary analysis, to examination of the device by the offices responsible for issuing the CCC mark.

ISEMED has set up an agreement with a local company, that with no interest in the marketing of medical devices, assists companies in the performance of registration practices. Thus ISEMED guarantees maximum confidentiality on technical and functional know-how of the products registered.

Our support includes:

- classification of the medical device,

- activation of the local representative,

- preparation of documents required for SFDA registration,

- maintenance of relationships with local reference

- finding and appointing of those responsible for post-sales