Notice - Cessation of Recognition of Orion Registrar Inc. as a Registrar by Health Canada

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TO ALL CANADIAN AND FOREIGN MANUFACTURERS
Attention to persons responsible for regulatory affairs and quality systems

APPLICATION

The cessation of recognition by Health Canada of Orion Registrar Inc. as a registrar affects all CANADIAN and FOREIGN manufacturers:

• holding class II, III, and IV medical device licences supported by a quality system certificate issued by Orion Registrar Inc.
• applying for class II, III and IV medical device licences with a quality system certificate issued by Orion Registrar Inc.
• applying for class II, III and IV medical device amendments with a quality system certificate issued by Orion Registrar inc
• in the process of having their quality system registered under CMDCAS by Orion Registrar Inc.

CONTEXT

Section 32.1 of the Medical Devices Regulations (the Regulations) requires Health Canada to recognize third-party registrars so that medical device manufacturers are able to comply with the quality management systems (QMS) provisions of the Regulations, and to assess and monitor the activities of these registrars to ensure that they operate in compliance with the Regulations at all times.

Pursuant to section 32.5 of the Regulations, the Department may cease recognition of a registrar if the registrar no longer meets the requirements of section 32.1 of the Regulations.

Health Canada recognition of a registrar is predicated on accreditation of the registrar by the Standards Council of Canada (SCC). The accreditation of Orion Registrar Inc. has been suspended by the SCC as of June 10, 2005.

Suspension by the SCC of the accreditation of a registrar means that the registrar no longer meets the requirements of section 32.1. As a result, Health Canada may cease to recognize the registrar and will, from the date of suspension, refuse to accept QMS certificates issued by the registrar as the basis for new licence applications and applications to amend existing licences.

A registrar whose accreditation has been suspended by the SCC may appeal the suspension. Based on information submitted in support of the appeal, the SCC will decide whether the accreditation should be withdrawn or reinstated.

Health Canada may reinstate the recognition of Orion Registrar Incorporated as a registrar under Section 32.1 of the Regulations if and when the suspension of their accreditation by the SCC is lifted.

IMPACT OF THE CESSATION OF RECOGNITION ON NEW DEVICE LICENCE APPLICATIONS AND AMENDMENTS TO EXISTING LICENCES

Effective June 10, 2005 and until further notice, new licence applications and amendments to existing licences based on QMS certificates issued by Orion Registrar Inc. will not be accepted by Health Canada.

IMPACT OF THE CESSATION OF RECOGNITION ON EXISTING DEVICE LICENCES

Existing QMS certificates issued by Orion Registrar Inc. and provided in support of issued licences remain valid until further notice. If the SCC ultimately decides to withdraw the accreditation of Orion Registrar Inc., Health Canada will take appropriate measures with the affected manufacturers regarding their device licences.

ADDITIONAL INFORMATION

For additional information on regulatory quality systems related issues and processes, Health Canada can be contacted by writing, calling, faxing, or e-mailing the following:

Quality Systems Section
Medical Devices Bureau
Therapeutic Products Directorate
Room 1605, Statistics Canada Main Building
Tunney's Pasture, Address Locator 0301H1
Ottawa, Ontario
K1A 0L2
Phone: (613) 952-8250
Fax: (613) 954-7666
E-mail: iso13485_cmdcas_scecim@hc-sc.gc.ca