Rob Packard, a Quality System & Regulatory expert of Medical Device Academy, was gracious enough to allow us to post these articles he wrote recently on Canadian Medical Device Regulations.  Thx Rob!

The first article is a hypothetical case study that explains the process of obtaining a Health Canada Medical Device License.

The second and third articles are a 2 Part Series on the 11 Steps to Obtaining CMDCAS Certification.

• Part 1 focuses on the process of verifying the classification, selecting a registrar and obtaining a quote for CMDCAS certification. 
• Part 2 focuses on the process of updating the quality system (Licensing, Mandatory Problem Reporting, & Recall Procedures), finding a distributor, training your staff that touches parts of the quality system that are impacted by the CMDR, conducting internal auditing to applicable sections of the CMDR, going thru the CMDCAS certification audit, and lastly if applicable your Submission of your License Application. 

TÜV America Inc. announces that its registrar division, TÜV Management Service, has received accreditation from Standards Council of Canada (SCC) and Health Canada as a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar on August 8, 2001. CMDCAS recognition enables TÜV to perform accredited ISO 13485 / 13488 quality systems certification services for medical device manufacturers marketing their products in Canada through the Medical, Health and Sports division of TÜV Product Service. TÜV becomes the first registrar in the world to be CMDCAS recognized by Health Canada and the SCC to provide ISO 13485 / 13488 certification. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization.

To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada. Published on May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already in the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications. (ISO 13485 and 13488:1996 are quality management standards specific to the medical device industry, which supplement ISO 9001 and ISO 9002:1994 quality management systems standards)

Canadian Requirements

To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada.

Manufacturers of Class 2 devices must comply with the requirements for ISO 13488 and manufacturers of Class 3 and 4 devices need to meet the requirements for ISO 13485. Accreditation to these standards must be achieved by a Health Canada recognized SCC accredited registrar. The SCC is deeming these registrars Canadian Medical Devices Conformity Assessment System (CMDCAS) registrars.

TÜV Management Service, the registrar division of TÜV America Inc., is the first registrar to receive accreditation by the SCC and Health Canada as a CMDCAS recognized registrar. This accreditation enables TÜV Management Service to provide clients ISO 13485 or ISO 13488 certification for medical device manufacturers selling their product in the Canadian marketplace. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization, TÜV Product Service.

About CMDCAS

Published May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) were due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already on the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications.