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• Regulation_(JP)_MD&IVDR_Ordinance on Standards for Manufacturing Control and Quality Control Download
• Regulation_(AU)_MD&IVDR_Therapeutic Goods (Medical Devices) Regulations 2002 Download
• Regulation_(BR)_MD&IVDR_RDC 16/2013_Quality System Regulation Download
• Guidance_(US)_Convenience Kits Interim Regulatory Download
• Guidance_(US)_Sterilized Convenience Kits for Clinical and Surgical Use Download
• Guidance_(US)_Surgical Gown&Drape 510K Download
• Guidance_(US)_Surgical Mask 510K Download
• Guidance_(US)_Medical Glove 510K Download
• Guidance_(CA)_List of Recognized Standards for Medical Devices Download
• Regulation_(CA)_Medical Device_SOR-98-282_Quality System Regulation Download