List of Registrars Recognized by Health Canada

As of a June 1, 2011 publication by Health Canada, the following registrars are recognized under section 32.1 of Medical Devices Regulations (MDR).

As of publication, all registrars are authorized by Health Canada to issue quality management system certificates for:

  • CAN /CSA ISO 13485:2003
  • ISO 13485:2003

Registrar Contact Information
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 [at] bsiamericas [dot] com
Web site: http://www.bsiamerica.com
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 [dot] global [at] dekra [dot] com
Web site: http://www.dekra-certification.com/en/home
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 [dot] devices [at] dqs [dot] de
Web site: https://de.dqs-ul.com/en/home.html
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 [dot] devices [at] dqs [dot] de
Web site: http://www.dqs-medizinprodukte.de/en
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 [at] intertek [dot] com
Web site: http://www.intertek-sc.com/index.htm
Laboratoire national de metrologie et d’essais, division certification G-MED
1, rue Gaston Boissier
Paris CEDEX 15
75724 France
Phone: 33 1 40 43 39 72
Fax: 33 1 40 43 37 37
E-mail: corinne [dot] delorme [at] lne [dot] fr
Web site: http://www.gmed.fr
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 [at] lga [dot] de
Web site: http://www.lga-intercert.com
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 [at] lrqa [dot] com
Web site: http://www.lrqausa.com
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 [dot] devices [at] nsai [dot] ie
Web site: http://www.nsai.ie
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 [at] tga [dot] gov [dot] au
Web site: http://www.tga.gov.au/about/tga-structure.htm
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 [dot] phipps [at] qmisaiglobal [dot] com
Web site: http://www.saiglobal.com
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 [at] sgs [dot] com
Web site: http://www.sgs.co.uk/
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 [at] tuv [dot] com
Web site: http://www.tuv.com/en/usa/home_3.jsp
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 [at] tuvam [dot] com
Web site: http://tuvamerica.com/newhome.cfm
TUV USA, Inc.
215 Main Street, Suite 3
Salem, NH 03079
USA
Phone: 603-870-8023
Fax: 603-870-8026
E-mail: request [at] tuv-usa [dot] com
Web site: http://www.tuv-nord.com/us/
Underwriters Laboratories, Inc. (ULI)
333 Pfingsten Road
Northbrook IL 60062-2096
USA
Phone: 408-754-6500
Fax: 408-689-6500
E-mail: A [dot] Mcroberts [at] uk [dot] ul [dot] com
Web site: http://www.ul.com