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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
| Registrar | Contact Information | Registrar Status with Health Canada |
Standards (against which the registrar is authorized by Health Canada to issue quality system certificates) |
||
|---|---|---|---|---|---|
| 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 Phone: +49 69 9 54 27 263 |
X | X | ||
| DQS Medizinprodukte GmbH | August-Schanz-Strasse 21 Phone: +49 69 95427 - 263 www.dqs-medicaldevices.com |
X | X | ||
Intertek Testing Services |
1829 32nd Avenue Phone: 514 631-3100 |
X | X | ||
| Laboratoire national de metrologie et d'essais, division certification G-MED |
1, rue Gaston Boissier Phone: 33 1 40 43 39 72 |
X | X | ||
| LGA Intercert GmbH | Tillystrasse 2 Phone: 49 911 6 55 41 61 |
X | X | ||
| Lloyd's Register Quality Assurance Inc. (LRQA Inc. ) | 1401 Enclave Parkway, Phone: 281 398-7370 |
X | X | ||
| National Standards Authority of Ireland (NSAI) | 1 Swift Square Phone: 353 1 807 3800 |
X | X | ||
| Office of Manufacturing Quality Monitoring and Compliance Group Therapeutic Goods Administration | 136 Narrabundah Lane Phone: +61 2 6232 8790 |
X | X | ||
| SAI Global Certification Services Pty Ltd. |
286 Sussex Street Phone: 416-401-8700, 800-465-3717 |
X | X | ||
| SGS United Kingdom Ltd. | Inward Way Phone: +44 (0) 1934 522917 |
X | X | ||
| TUV Rheinland of North America, INC. | North American Headquarters Phone: 888 743-4652 (Canada and USA only) |
X | X | ||
| TÜV SÜD America Inc. | 10 Centennial Drive Phone: 800 888-0123 (Canada and USA only) |
X | X | ||
| TUV USA, Inc. | 215 Main Street, Suite 3 Phone: 603-870-8023 |
X | X | ||
| Underwriters Laboratories, Inc. (ULI) | 333 Pfingsten Road Phone: 408-754-6500 |
X | X | ||
