In 2010, the medical device industry is about to enter the era of high standards
On January 19, the 2010 National Food and Drug Administration Work Conference officially came to an end. At the meeting, the State Food and Drug Administration clearly stated that this year my country will focus on ensuring the quality and safety of essential medicines and improving the quality standards of 307 medicines previously included in the essential medicine list. In the medical device industry, this year the country will increase its efforts to revise basic and general medical device standards, and at the same time complete 89 medical device standards revision work.
Guo Fanli, a researcher in the pharmaceutical industry, pointed out that this time the country will amend the relevant standards of the medical device industry, which means that the medical device industry is about to enter the era of "high standards".
According to data from the Industrial Research Center, my country currently has 180 national standards for medical devices, and there are more than 700 industry standards for medical devices. In 2009, my country formulated 24 new national standards for medical devices, and introduced nearly 200 new industry standards, initially forming a medical device standard system with a certain coverage.
Guo Fanli pointed out that, however, the standards for these medical devices are far from enough. This "insufficiency" is manifested in two aspects. First, it is insufficient in "quantity". my country's medical device industry standards are far from the standards and refinements of foreign standards, and there is a big gap in quantity compared with foreign countries; secondly, the "quality" is not enough. my country's medical device industry standards are not standardized, so there will be inconsistencies between local and local standards; in addition, compared with foreign medical device industry standards, my country's standards are far lower than foreign standards. In other words, products that have passed the medical device industry standards in my country may not pass the corresponding standards abroad.
In response to this situation, my country will further revise the standards for medical devices starting this year. The focus of the revision includes in vitro diagnostic reagents, surgical implants, hemodialyzers, etc. At the same time, the State Food and Drug Administration will also strengthen the research work of medical device standards, improve the entry threshold of enterprises on the basis of the original medical device standard system, and organize departments at all levels to carry out basic research on standard verification, test methods, and key indicators.
The "2010-2015 China Medical Device Industry Investment Analysis and Forecast Report" pointed out that there are currently more than 13,000 medical device manufacturers in my country, but the problem of "scattered, chaotic, and poor" industries is still very serious. This time the country will increase its efforts to revise basic and general medical device standards, which will help improve the overall level of medical device companies and pave the way for my country's medical device industry to further enter the world in the future.
Beijing Kelian Shenghua Medical Technology Co., Ltd 京ICP備05070151號 互聯(lián)網(wǎng)藥品信息服務(wù)資格證書號：（京）-非經(jīng)營性-2017-0043