Medical device industry is about to enter the era of high standards

19 January, 2010-national food and Drug Administration Conference officially came to an end.

At the meeting, state explicitly raised this year will focus on ensuring the quality and safety of essential medicines and to improve access to essential medicines list before the 307 drug quality standards. Whereas in the medical device industry, this year, the State will increase the fundamental and universal standards of medical devices, while complete modified 89 medical device standards work.

Investment advisor in the pharmaceutical industry researcher Guo where the national ceremony that will modify the medical device industry standards means that the medical device industry is about to enter the era of "high standard".

According to investment and advisory industry research center information display, at present a total of 180 national standards for medical devices, and medical device industry standards up to 700 items.

In 2009, our new developed 24 national standards for medical devices, industry standards and also new nearly 200 entries, it forms a certain coverage of medical devices standards system.

Guo where the ceremony that, however these medical devices standards still far from enough.

The "not enough" manifests itself in two ways, first is the "quantity". Chinese medical device industry standard far abroad standard specifications and refinement, compared the quantities and abroad, there are large gaps; followed by "quality" is not enough. Chinese medical device industry standards specification because it does not, so there will be local to local standards inconsistencies, and compared to the medical device industry standards abroad, our standard is much better than abroad. That is, in our country adopted the medical device industry-standard products, but abroad may not be able to pass the corresponding standards.

To address this situation, China will this year on medical device standards further amendments.

Revised priorities include in vitro diagnostic reagents, surgical implants, hemodialysis, etc. At the same time, the State will strengthen standards for medical research in the original medical equipment on the basis of the standard system, improve the entry threshold of enterprises, organizations at all levels of the sector standards verification, test methods, key indicators of fundamental research.

Investment advisor in the 2010-2015, China medical device industry investment analysis and forecast report pointed out that more than 1 million more than 3 thousand medical device manufacturing enterprises, but industry "powder, mess and difference" problem remains serious.

This country will increase the fundamental and universal medical device standards efforts to help improve medical device changes the overall level, China medical device industry for the future could further world pave the way for the stage.