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Impact on the industry's new "Medical Devices Regulations"

2014/8/14 10:27:31Click on the£º

Implementation of the 14-year "Medical Devices Regulations" Come on, has finally ushered in the first "overhaul." March 31, the State Food and Drug Administration released a new version of the "Medical Devices Regulations", a total of eight chapters 80,which is  comprehensive coverage of medical equipment research and development, production, distribution, use and other sectors, and it will be held on June 1 this year officially implemented. This issue we invited industry experts to further explore how the impact of the new regulations on China's medical device industry will be generated.

Space is huge, we face opportunities, from the current situation, our local device companies are more concentrated in the low-end market consumption of conventional varieties, domestic enterprises in high-end imaging, high-value consumables (such as endoscopes, etc.) and other areas are still in a weak position ,there is  a huge space for future import substitution. On the basis of policy support, its technology, talent and capital accumulation, the domestic enterprises are facing major opportunities for development. China Pharmaceutical Industry: our local device companies are more concentrated in the low-end market consumption of conventional varieties, what do you think is the main reason for this phenomenon?

Cai Nong: there are three main reasons:

 Technical capacity reasons: supporting domestic manufacturers and vendors of technology in general is relatively backward; many areas lack appropriate senior professionals. 

Policy for environmental reasons: inadequate protection of intellectual property; insufficient incentives for innovation.

 Operators for their own reasons: profit-oriented thinking; lack of innovation.

Hao xinbao: The main reason is the accumulation of technology which is not enough, it has low industrial level. Medical Devices includes both materials, machining and electronic control high requirements of major medical equipment, but also the consumption of low-tech conventional varieties. For the former R & D and production, it is depended on the overall level of technology. Second, the high-tech medical equipment long development cycles, large capital investment, limit its development in the country's small and medium sized companies in the equipment. Third, medical institutions tend to use imported medical equipment, confidence in the domestic high-tech medical equipment has a gradual build process. So although there are still many local companies focused on routine consumables low-end market, in the past two decades, high-tech medical equipment in the proportion of domestic medical devices  grow  through the introduction of technology digestion and independent research and development.

Zhong zhihui: the following main reasons:

 First, China's medical device industry and regulatory standardization started late, the overall technical level is not high, that the industry back on track, or when the true sense of standardization has since 2000 Ordinance; 

 Second, the State Council Decree No. 276 has been in 14 years, the implementation of existing legislation and policy system are too old, they no longer meet the current level of productivity of domestic medical device and technology development, and may even block the development of the situation. For example, "Mr. postpartum registration" regulatory model, the enterprise is unable to know the availability of new product research marketing authorization, we are afraid  of  investing research for new products;