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1. CFR - Code of Federal Regulations Title 21 https://www.accessdata./scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
2. Medical Device Single Audit Program (MDSAP) https://www./medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap
3. EUMDR指南MDCG https://health.ec./medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
醫(yī)療器械投放市場(chǎng)在哪個(gè)國家，就適用哪里的法規(guī)。  下面我們看看中國的有關(guān)法規(guī)要求：
www.nmpa.gov.cn
2.國家藥品監(jiān)督管理局醫(yī)療器械技術(shù)審評(píng)中心 https://www./
3.醫(yī)療器械標(biāo)準(zhǔn)查詢 http://app./biaogzx/qxqwk.do
4.醫(yī)療器械行業(yè)標(biāo)準(zhǔn) http://app./jianybz/jybzTwoGj.do?formAction=listTsDalid&type=ylqx&page=list_ylqx
5.醫(yī)療器械非采標(biāo)推薦性行業(yè)標(biāo)準(zhǔn) http://app./jianybz/jybzTwoGj.do?formAction=listTsDalid&type=qxtjbz&page=list_qxtjbz
6.醫(yī)療器械分類目錄查詢 http://app./biaogzx/dataGk.do
7.分類界定文件查詢 http://app./biaogzx/flmlbczlk.do
8.I類產(chǎn)品補(bǔ)充分類信息 http://app./biaogzx/flmlbczlk.do?formAction=chadFlmk&type=2015#none
9.醫(yī)療器械標(biāo)準(zhǔn)與分類管理 https://www./nifdc/bshff/ylqxbzhgl/index.html
10.醫(yī)療器械法規(guī)查詢 https://www.nmpa.gov.cn/xxgk/fgwj/index.html
11.國家標(biāo)準(zhǔn)全文公開系統(tǒng) http://openstd./bzgk/gb/index
12.分類目錄 指導(dǎo)原則 標(biāo)準(zhǔn) https://www./flfg/zdyz/flmlbzh/flmlylqx/index.html
13.審評(píng)論壇 https://www./splt/index.html
14.器審云課堂 https://learn./
15.醫(yī)療器械UDI數(shù)據(jù)庫 https://udi.nmpa.gov.cn/
16.醫(yī)療器械召回 https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/index.html
17.國家局高級(jí)研修學(xué)院 http:///
18.國家醫(yī)療器械不良事件監(jiān)測(cè)信息系統(tǒng) https://maers./console/login.ftl
19.國家局審核查驗(yàn)中心 https://www./cfdi/index?module=A001&nty=A25
（中國法規(guī)內(nèi)容來源公眾號(hào)“叁顆籽”） |
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