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CFDA Releases 2016 China Medical Device Registration Statistics
Category: Industry News
Release time: 2016-09-23
Summary: The first China Pharmaceutical Regulatory Science Conference 2016, hosted by the China Association for Drug and Medical
From September 20 to 21, the first China Drug Regulatory Science Conference 2016, hosted by the China Association for Pharmaceutical and Medical Device Regulation Research, was held in Beijing. At the conference, Wang Zhexiong, Director of the Medical Device Registration Division of the National Medical Products Administration, presented registration data for medical devices for the first half of 2016.
Wang Zexiong said that from January to June this year, the Administration approved a total of 4,346 medical device registrations. Among these, 1,140 were first-time registrations, 2,487 were renewal registrations, and 719 were registrations involving changes to licensed items. Meanwhile, the Administration rejected a total of 298 medical device registration applications.
He stated that the number of registrations in the first half of this year showed a significant increase, rising by 28.4% year-on-year; among them, domestically produced in vitro diagnostic reagents demonstrated particularly strong growth momentum. The number of Class III IVD registrations for domestically produced products was 2.5 times that of domestically produced active and passive medical devices combined, and the top five companies in terms of registration volume were all Class III IVD enterprises.
Meanwhile, the overall development trend of domestically produced medical devices is positive, with the number of registrations for Class III domestic medical devices exceeding that of imported ones. Moreover, a clear trend of differentiation is emerging between domestically produced and imported medical devices: while imported products are predominantly active and passive devices, domestically produced products are more commonly found in the IVD sector—each type has its own distinct advantages.
Wang Zexiong also stated that the results of the approval process for innovative medical devices are already becoming evident. As of the end of June 2016, a total of 379 applications for special approval of innovative medical devices had been received, and 63 products had been designated to enter the special approval pathway for innovative medical devices. Among these, 16 innovative medical device products have already entered the market—such as the second-generation gene sequencers from companies like BGI, the digital mammography equipment from Tianjin Kening, the implantable vagus nerve stimulator from Beijing Pinchi, and the drug-eluting peripheral balloon dilation catheter from Beijing Xianruida.
Wang Zexiong introduced that the “Priority Review Procedure for Medical Devices” is currently under review and will soon be released.
According to a speech delivered at this conference by Kong Fanpu, Director of the Medical Device Technical Review Center of the National Medical Products Administration, from January to August 2016, a total of 7,088 medical device technical reviews were completed, with 6,765 applications received. Innovative medical devices entering the special approval pathway have an average review time of 37 working days, representing a reduction of more than 60% compared to the review time for conventional products.
Keywords: CFDA Releases 2016 China Medical Device Registration Statistics
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