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Proactive Disclosure

Proactive Disclosure

Drugs and Health Products

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List of registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR)

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(PDF Version - 44 K)

Date of issue: June 1, 2011

List of registrars
Registrar	Contact Information	Registrar Status with Health Canada			Standards (against which the registrar is authorized by Health Canada to issue quality system certificates)
Registrar	Contact Information	Recognized under section 32.1 of Medical Devices Regulations (MDR)	Applicant under section 32.1 of MDR, but certificates accepted by Health Canada	Ceased to be recognized under section 32.5 of Medical Devices Regulations (MDR)	CAN /CSA ISO 13485:2003 and ISO 13485:2003
BSI America, Inc.	12110 Sunset Hills Road Suite 200 Reston, Virginia, 20190-3231 USA Phone: 800 862-4977 (Canada and USA only) 703 437-9000 Fax: 703 437-9001 E-mail: inquiry@bsiamericas.com Web site: http://www.bsiamericas.com	X			X
DEKRA Certification B.V.	Utrechtseweg 310 Arnhem, 6812 AR Netherlands Phone: +31 26 3 56 20 09 (Netherlands) 925-283-7535 (USA) Fax: +31 26 3 52 58 00 E-mail: medical.global@dekra.com Web site: www.dekra-certification.com	X			X
DQS GmbH	August-Schanz-Strasse 21 Frankfurt am Main D-60433 Germany Phone: +49 69 9 54 27 263 Fax: +49 69 9 54 27 388 E-mail: medical.devices@dqs.de Web site: http://www.dqs.de	X			X
DQS Medizinprodukte GmbH	August-Schanz-Strasse 21 Frankfurt am Main D-60433 Germany Phone: +49 69 95427 - 263 Fax: +49 69 95427 - 388 E-mail: medical.devices@dqs.de Web site: www.dqs-medicaldevices.com	X			X
Intertek Testing Services North America Ltd. (ITS)	1829 32nd Avenue Lachine, Québec, H8T 3J1 Canada Phone: 514 631-3100 Fax: 514 631-1133 E-mail: intertek-sc@intertek.com Web site: http:// www.intertek-sc.com	X			X
Laboratoire national de metrologie et d'essais, division certification G-MED	1, rue Gaston Boissier 75724 Paris CEDEX 15 France Phone: 33 1 40 43 39 72 Fax: 33 1 40 43 37 37 E-mail: corinne.delorme@lne.fr Web site: http://www.gmed.fr	X			X
LGA Intercert GmbH	Tillystrasse 2 D-90431, Nuremberg Germany Phone: 49 911 6 55 41 61 Fax: 49 911 6 55 41 70 E-mail: intercert@lga.de Web site: http://www.lga-intercert.com	X			X
Lloyd's Register Quality Assurance Inc. (LRQA Inc. )	1401 Enclave Parkway, Suite 200 Houston, Texas, 77077 USA Phone: 281 398-7370 Fax: 281 398-7337 E-mail: marketing- usa@lrqa.com Web site: http://www.lrqausa.com	X			X
National Standards Authority of Ireland (NSAI)	1 Swift Square Northwood, Santry Dublin 9 Republic of Ireland Phone: 353 1 807 3800 Fax: 353 1 807 3844 E-mail: medical.devices@nsai.ie Web site: http://www.nsai.ie	X			X
Office of Manufacturing Quality Monitoring and Compliance Group Therapeutic Goods Administration	136 Narrabundah Lane SYMONSTON ACT 2609 Australia Phone: +61 2 6232 8790 Fax: +61 2 6232 8426 E-mail: GMP@tga.gov.au Web site: http://www.tga.gov.au/international/ canada-qms.htm	X			X
SAI Global Certification Services Pty Ltd.	286 Sussex Street Sydney, NSW 2000 Australia Phone: 416-401-8700, 800-465-3717 Fax: 416-401-8650 E-mail: malcolm.phipps@qmi-saiglobal.com Web Site: http://www.saiglobal.com	X			X
SGS United Kingdom Ltd.	Inward Way Rossmore Road Ellesmere Port, Cheshire CH65 3EN United Kingdom Phone: +44 (0) 1934 522917 Fax: +44 (0) 1934 522137 E-mail: sgsprodcert@sgs.com Web site: http://www.uk.sgs.com	X			X
TUV Rheinland of North America, INC.	North American Headquarters 12 Commerce Road Newtown , Connecticut , 06470 USA Phone: 888 743-4652 (Canada and USA only) 203 426-0888 Fax: 203 426-4009 E-mail: info@tuv.com Web site: http://www.us.tuv.com	X			X
TÜV SÜD America Inc.	10 Centennial Drive Peabody, Massachusetts, 01960 USA Phone: 800 888-0123 (Canada and USA only) 978 573-2500 Fax: 978 977-0157 E-mail: info@tuvam.com Web site: http://www.tuvamerica.com	X			X
TUV USA, Inc.	215 Main Street, Suite 3 Salem, NH 03079 USA Phone: 603-870-8023 Fax: 603-870-8026 E-mail: request@tuv-usa.com Web site: http://www.tuv-usa.com	X			X
Underwriters Laboratories, Inc. (ULI)	333 Pfingsten Road Northbrook IL 60062-2096 USA Phone: 408-754-6500 Fax: 408-689-6500 E-mail: A.Mcroberts@uk.ul.com Web site: http://www.ul.com	X			X