| 區(qū)域 | 檢索渠道 | 網(wǎng)站 | 關(guān)注模塊 |
| 國(guó)際標(biāo)準(zhǔn) | ISO 標(biāo)準(zhǔn) | https://www.iso.org/home.html | 每周更新適用的標(biāo)準(zhǔn)知識(shí)庫(kù)清單 |
| IEC 標(biāo)準(zhǔn) | https://webstore.iec.ch/home |
| ASTM 標(biāo)準(zhǔn) | https://www.astm.org/Standard/index.html |
| EN 標(biāo)準(zhǔn) | https://www.cencenelec.eu/ |
| ISO update | https://www.iso.org/iso-update.html | ISO標(biāo)準(zhǔn)每月發(fā)布的報(bào)告 |
| IMDRF | IMDRF | https://www.imdrf.org/ | 國(guó)際醫(yī)療器械監(jiān)管機(jī)構(gòu)論壇(International Medical Device Regulators Forum) |
| 歐盟 | 歐盟官方公告-OJ | https://eur-lex.europa.eu/homepage.html | Access to the Official Journal |
| Medical Devices - Sector - Latest updates | https://ec.europa.eu/health/medical-devices-sector/latest-updates_en | 醫(yī)療器械相關(guān)資訊的更新 |
| Public Health-Latest updates | https://ec.europa.eu/health/latest-updates_en | 公共健康模塊的咨詢更新 |
| EUDAMED的概覽 | https://health.ec.europa.eu/medical-devices-eudamed/overview_en | EUDAMED模塊公布的時(shí)間表 |
| 通用規(guī)范、指南的征求意見稿 | https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives_en | 征求意見 |
| European Commission資訊更新 | https://ec.europa.eu/growth/news_en | 通告、公告更新 |
| Harmonised Standards | https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en | MDR下的協(xié)調(diào)性標(biāo)準(zhǔn) |
| MDCG 指南 | https://ec.europa.eu/health/md_sector/new_regulations/guidance_en | MDCG 所有模塊下醫(yī)療器械的相關(guān)指南文件 |
| EUDAMED數(shù)據(jù)庫(kù) | https://ec.europa.eu/health/md_eudamed/actors_registration_en | 歐盟EUDAMED數(shù)據(jù)庫(kù) |
| Team NB | https://www.team-nb.org/ | 公告機(jī)構(gòu)組織發(fā)布的信息，會(huì)轉(zhuǎn)載OJ、MDCG的資訊發(fā)布 |
| CAMD | https://www.camd-europe.eu/news/ | 各主管當(dāng)局的小組發(fā)布文章，如IVDR過(guò)渡期解答 |
| Bfarm | https://www.bfarm.de/EN/News/News-from-the-divisions/Medical-devices-news/_node.html | 德國(guó)主管當(dāng)局信息更新 |
| MDD下公告機(jī)構(gòu)指導(dǎo)文件（NBOG） | https://www.nbog.eu/nbog-documents/ | MDD下公告機(jī)構(gòu)指導(dǎo)文件 |
| MEDDEV指南 | https://ec.europa.eu/health/md_sector/current_directives_en | MEDDEV更新的醫(yī)療器械指南文件 |
| 美國(guó) | FDA近期發(fā)布的指南文件 | https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents | 關(guān)注最新的醫(yī)療器械指南文件 |
| FDA歷史發(fā)布的指南文件 | https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products | 關(guān)注醫(yī)療器械相關(guān)指南文件 |
| 21 CFR Part 800-898 Medical Devices | https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl | 關(guān)注FDA醫(yī)療器械法規(guī)的變化 |
| 加拿大 | 加拿大MDR | https://laws-lois.justice.gc.ca/eng/regulations/ | 關(guān)注加拿大MDR醫(yī)療器械法規(guī)的變化 |
| 醫(yī)療器械最新消息 | https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html | 關(guān)注加拿大醫(yī)療器械相關(guān)的最新動(dòng)態(tài) |
| What's new: Medical devices |
| 英國(guó) | 英國(guó)醫(yī)療器械監(jiān)管Medical devices regulation and safety | https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety | 關(guān)注英國(guó)醫(yī)療器械相關(guān)的最新動(dòng)態(tài) |
| 英國(guó)醫(yī)療器械指南 | https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra | 關(guān)注英國(guó)醫(yī)療器械相關(guān)的指南文件 |
| MDSAP區(qū)域（日本、巴西、澳大利亞） | FDA官網(wǎng) | https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-international-regulations-english-australia-brazil-canada-japan-and-usa | 關(guān)注MDSAP五國(guó)的QMS相關(guān)法規(guī) |
| 澳大利亞 | Therapeutic Goods Administration (TGA) | https://www.legislation.gov.au/Search/Therapeutic%20Goods | 關(guān)注如下三個(gè)法規(guī)的變化： |
| 1、Therapeutic Goods Act 1989治療產(chǎn)品法案，其他法規(guī)基礎(chǔ) |
| 2、Therapeutic Goods Regulations 1990 治療產(chǎn)品法規(guī) |
| 3、Therapeutic Goods (Medical Devices) 治療產(chǎn)品（醫(yī)療器械）法規(guī)，注冊(cè)，符合性評(píng)估主要依據(jù)Regulations 2002 |
| TGA官網(wǎng) | https://www.legislation.gov.au/WhatsNew | 聯(lián)邦立法紀(jì)事在最近21天內(nèi)公布的材料清單， |
| What's New on the Federal Register of Legislation | 關(guān)注澳大利亞醫(yī)療器械相關(guān)的最新動(dòng)態(tài) |
| Therapeutic Goods Administration (TGA) | https://www.tga.gov.au/latest-news-updates | Latest news & updates |
| Guidance and resources | https://www.tga.gov.au/resources | 所有指南文件的檢索 |
| Publications | https://www.tga.gov.au/resources/publication/publications | 公告發(fā)布 |
| Latest News | https://www.tga.gov.au/news/news | 最新資訊發(fā)布 |
| Consultations | https://www.tga.gov.au/resources/consultation | 征求意見稿發(fā)布 |
| 巴西 | ANVISA官網(wǎng) | https://www.gov.br/anvisa/pt-br | 關(guān)注如下兩個(gè)法規(guī)的變化： |
| 1、Resolution RDC 185/2001 巴西ANVISA注冊(cè)法規(guī) |
| 2、RDC 40/2015 Defines the enrollment/ notification requirements of medical products. 適用于Class I、II的登記備案要求 |
| 第三方咨詢機(jī)構(gòu)Emergo | https://www.emergobyul.com/resources/regulations-brazil | Resolution-RDC-16-2013 （BGMP） GMP要求 |
| 日本 | 日本法規(guī)翻譯網(wǎng) | http://www.japaneselawtranslation.go.jp/law/list/?ft=2&re=2&dn=1&yo=medical+device&ia=03&ja=04&ph=&x=35&y=15 | 關(guān)注日本醫(yī)療器械法規(guī)的變化 |
| 厚生勞動(dòng)省官網(wǎng) | https://www.mhlw.go.jp/english/index.html | 關(guān)注“Pharmaceuticals and Medical Devices（藥品和醫(yī)療器械）”模塊的變化 |
| 日本藥品和醫(yī)療器械局（PMDA） 官網(wǎng) | https://www.pmda.go.jp/english/index.html | 關(guān)注日本“Medical devices”醫(yī)療器械模塊的更新 |
| 香港 | 衛(wèi)生部-醫(yī)療器械官網(wǎng) | https://www.mdd.gov.hk/tc/home/index.html | 關(guān)注香港醫(yī)療器械“醫(yī)療儀器行政管理制度” |
| l 馬來(lái)西亞 | 馬來(lái)西亞-醫(yī)療器械管理局(MDA)官網(wǎng) | https://www.mda.gov.my/ | 馬來(lái)西亞醫(yī)療器械法規(guī)及指南文件 |
| 韓國(guó) | 韓國(guó)食品和藥品安全部官網(wǎng) | https://www.mfds.go.kr/eng/index.do | 關(guān)注韓國(guó)Medical Devices 模塊的變化 |
| 瑞士 | 瑞士聯(lián)邦法律 | https://www.fedlex.admin.ch/eli/cc/2020/552/en | 關(guān)注Medical Devices Ordinance法規(guī) |
| 瑞士衛(wèi)生部 | https://www.swissmedic.ch/swissmedic/en/home/news.html | 關(guān)注瑞士醫(yī)療器械法規(guī)的變化 |
| 菲律賓 | 菲律賓FDA官網(wǎng) | https://www.fda.gov.ph/ | 關(guān)注菲律賓醫(yī)療器械法規(guī)的變化（FDA circular, FDA Memorandum, Memorandun circular板塊） |
| 東盟 | 東盟ASEAN官網(wǎng) | https://asean.org/ | 關(guān)注醫(yī)療器械法規(guī)的變化 |
| ASEAN DOCS | https://docs.asean.org/SitePages/DocumentSearch.aspx | 指南文件檢索 |
| WHO | WHO官網(wǎng) | https://www.who.int/ | 關(guān)注醫(yī)療器械法規(guī)的變化 |
| Emergency use listing (EUL) | https://www.who.int/teams/regulation-prequalification/eul/ | 白名單 |
| Coronavirus disease (COVID-19) Pandemic — Emergency Use Listing Procedure (EUL) open for IVDs | https://extranet.who.int/pqweb/vitro-diagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open | 新冠EUL |