MDSAP International Regulations [English] (Australia, Brazil, Canada, Japan, and USA)
Australia
Brazil
- Brazilian Health Surveillance Agency
- Resolution RDC 16 2013
- Resolution RDC 23 2012
- Resolution RDC 67 2009
Canada
Japan
USA
- 21 CFR 803 � MEDICAL DEVICE REPORTING
- 21CFR806--Subchapter H--Medical Devices--Part 806 Medical Devices; Reports of Corrections and Removals
- 21 CFR 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
- 21 CFR 820 - QUALITY SYSTEM REGULATION
- 21 CFR 821 - MEDICAL DEVICE TRACKING REQUIREMENTS