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Summary of 25 national medical device standard inquiry websites
2022.08.12
1. Asia
1) China

http://www.cssn.net.cn/cssn/index

2) India
https://www.icmr.gov.in/

3) Thailand
https://www.fda.moph.go.th/Pages/HomeP_D2.aspx

4) Malaysia
https://www.mda.gov.my/

5) Japan
https://www.pmda.go.jp/english/index.html

6) Turkey
https://www.tse.org.tr/

2. Europe
1) Germany

https://www.din.de/en

2) Italy
https://www.uni.com/#

3) France
https://www.afnor.org/

4) Austria
https://www.austrian-standards.at/

5) Spain
https://www.une.org/

6) Poland
https://www.pkn.pl/

7) Netherlands
https://www.nen.nl/

8) Hungary
https://prod.mszt.hu/hu-hu/

9) UK
https://www.bsigroup.com/

10) Portugal
http://www1.ipq.pt/

11) Czech Republic
https://www.unmz.cz/en/home/

12) Switzerland
https://www.snv.ch/en/

13) Belgium
www.nbn.be

14) Luxembourg
https://portail-qualite.public.lu/fr.html

15) Ireland
https://www.nsai.ie/

16) Slovakia
https://www.unms.sk/

3. Americas
1) America

https://www.fda.gov/

2) Canada
https://www.canada.ca/en.html

3) Brazil
https://www.gov.br/anvisa/pt-br

In the past two years, whether domestic or overseas, the IVD industry has experienced the speed and quantity of regulations, standards, and guidelines promulgated, especially if you are doing registration or R&D. In addition to those listed above, there are also EU websites, CLSI EP, ISO, IEC standards and other query websites that you often visit, and you need to pay attention to their dynamics frequently.
The standard query and collection are only the most basic, the important thing is the content of the update, the trend of the change, and whether it has any impact. These are the key points. . .