23
2016
-
09
CFDA revealed the registration of medical devices in China in 2016
From September 20 to 21,the first 2016 China pharmaceutical regulatory science conference hosted by China pharmaceutical regulatory Research Association was held in Beijing.Wang Zhexiong,director of the medical device registration department of the State Food and drug administration,introduced the registration data of medical devices in the first half of 2016 at the meeting.
Wang Zhexiong said that from January to June this year,the General Administration approved 4346 medical device registrations.Among them,1140 items were registered for the first time,2487 items were registered for renewal,and 719 items were registered for changes in licensing matters.At the same time,the general administration refused to register 298 medical device registration applications.
He said that the number of registrations increased significantly in the first half of this year,with a year-on-year increase of 28.4%;Among them,domestic in vitro diagnostic reagents are growing rapidly.The number of domestic class III IVD registrations is 2.5 times that of domestic active+passive products,and the top 5 enterprises are class III IVD enterprises.
At the same time,the overall development trend of domestic medical devices is good,and the number of domestic class III medical devices is more than that of imported ones.Moreover,the differentiation trend between domestic medical devices and imported medical devices is obvious:imported products are mainly active and passive,and domestic products are mostly in IVD,each with its own advantages.
Wang Zhexiong also said that the approval results of innovative medical devices have appeared.By the end of June 2016,379 applications for special approval of innovative medical devices had been received,63 products had been determined to enter the special approval channel of innovative medical devices,and 16 innovative medical device products had entered the market.For example,the second-generation gene sequencer of BGI and other companies,the breast X-ray digital tomography equipment of Tianjin Corning company,the implantable vagus nerve stimulator of Beijing Pinchi company,the drug-eluting peripheral balloon dilation catheter of Beijing xianruida company,etc.
According to Wang Zhexiong,the priority approval procedure for medical devices is being reviewed and released.
In addition,Kong Fanpu,director of the medical device technical evaluation center of the State Food and drug administration,delivered a speech at the conference.From January to August 2016,7088 medical device technical reviews were completed and 6765 were accepted.When innovative medical devices enter the special approval channel,the average acceptance time is 37 working days,which is more than 60%less than that of ordinary products.
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