Medical network - on August 17, August 15, the CFDA medical instrument technical review center issued this year 4, the medical device is preferred for examination and approval of application verification result of the public, with a total of three products fitting for prior approval. Specific include:
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產(chǎn)品名稱
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申請人
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同意理由
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疝修補(bǔ)片
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北京博輝瑞進(jìn)生物科技有限公司
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列入國家重點(diǎn)研發(fā)計(jì)劃
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胸主動脈覆膜支架系統(tǒng)
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北京華脈泰科醫(yī)療器械有限公司
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列入國家重點(diǎn)研發(fā)計(jì)劃
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基因測序儀
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武漢華大智造科技有限公司
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列入國家重點(diǎn)研發(fā)計(jì)劃
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It is reported that this year, the center has issued priority approval notice no. 3 this year, only 6 medical device products received priority approval, including:
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產(chǎn)品名稱
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申請人
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同意理由
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藥物洗脫球囊導(dǎo)管
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遼寧垠藝生物科技股份有限公司
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臨床急需，且在我國尚無同品種產(chǎn)品獲準(zhǔn)注冊的醫(yī)療器械。（可用于冠脈分叉病變）
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血液透析/濾過裝置
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廣州市暨華醫(yī)療器械有限公司
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列入國家重點(diǎn)研發(fā)計(jì)劃
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中空纖維膜血液透析濾過器
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成都?xì)W賽醫(yī)療器械有限公司
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列入國家重點(diǎn)研發(fā)計(jì)劃
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Released by CFDA last October 25, the medical instrument prior approval process, to meet the following conditions within the territory of one of the third class and import for the second and third class medical device registration approval implementation of priority:
(a) comply with any of the following circumstances medical devices:
1. Diagnosis or treatment of rare diseases with obvious clinical advantages;
2. Diagnosis or treatment of malignant tumor with obvious clinical advantages;
3. Diagnosis or treatment of elderly persons with specific and multiple diseases, and there is no effective diagnosis or treatment;
4. Special for children, with obvious clinical advantages;
5. Clinical needs are urgently needed, and there are no medical instruments licensed for registration in our country.
(2) medical devices listed in national science and technology major special projects or state key research and development plans.
(3) other medical devices that shall be subject to approval.
From the above six priorities for examination and approval of medical equipment products, you can see, there are five products because "included in the national key research and development" and to obtain prior approval, only a product because of clinical need to obtain prior approval.
For the approved companies, the pace of product launch will be greatly accelerated.
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