China

Legislation

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