MDSAP International Regulations [English] (Australia, Brazil, Canada, Japan, and USA)

 

Australia

• Therapeutic Goods (Medical Devices) Regulations 2002

Brazil

• Brazilian Health Surveillance Agency
• Resolution RDC 16 2013
• Resolution RDC 23 2012
• Resolution RDC 67 2009

Canada

• Medical Devices Regulations (SOR/98-282)

Japan

• Japanese Medical Device QMS Requirements and other related Regulatory Information

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