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序號(hào)

區(qū)域

檢索渠道

網(wǎng)站

關(guān)注模塊

1

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

2

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)

3

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

https://ec.europa.eu/health/md_eudamed/actors_registration_en

歐盟EUDAMED數(shù)據(jù)庫

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

3

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

4

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
    What's new: Medical devices

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)

5

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

6

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)

7

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) Regulations 2002
    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)

TGA官網(wǎng)
    What's New on the Federal Register of Legislation

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，
    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

8

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

9

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

10

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”

11

l  馬來西亞

馬來西亞-醫(yī)療器械管理局(MDA)官網(wǎng)

https://www.mda.gov.my/

馬來西亞醫(yī)療器械法規(guī)及指南文件

12

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

13

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

14

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）

15

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

16

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