Russell Regulatory Consultants Ltd

International Regulations and Guidances

USA

CFR – Code of Federal Regulations Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

 

Great Britain

The Medical Devices (Amendment) (Great Britain) Regulations 2023 | UK Statutory Instruments 2023 No. 627

https://www.legislation.gov.uk/uksi/2023/627/contents/made

 

Health Canada

Medical Devices Regulations (SOR/98-282)

https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

 

TGA Australia

Australian regulatory guidelines for medical devices (ARGMD)

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

 

PMDA (Japan) Regulation of Medical Devices

https://www.pmda.go.jp/english/review-services/regulatory-info/0002.html

 

NMPA (China) Regulation of Medical Devices

http://english.nmpa.gov.cn/medicaldevices.html

 

Brazil’s Regulation of Medical Devices (ANVISA)

https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices

 

ASEAN Medical Device Directive

https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

 

Russia’s Regulation of Medical Devices

http://publication.pravo.gov.ru/Document/View/0001202009030024

 

International Medical Device Regulators Forum (IMDRF)

Library of IMDRF Documents

https://www.imdrf.org/documents/library