Canadian Market Access

(Medical Device Reglations and CMDCAS)

The Canadian medical market is estimated at $5.7 billion USD, an impressive figure for its population size. Much of the device industry is supplied by imports, largely from the United States. The market is expected to increase by 4.8% annually to reach $7.2 billion USD in 2014.*

Challenges

Under Canada’s Medical Devices Regulations (MDR), medical device manufacturers must prove that the devices they market or sell are safe, effective and meet quality standards. Other than the lowest risk (Class I) items, all Medical Devices and In Vitro Diagnostic Devices (IVDDs) are required to meet specific quality criteria based on standards developed by the International Organization for Standardization (ISO).

To verify these requirements, manufacturers must contract with an independent registrar who is accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and is recognized by Health Canada (the Canadian Ministry of Health).

A registrar confirms a manufacturer's quality management system operates in compliance with a Canadian version of ISO 13485 standards by assessing procedures and product management in the following main topic areas:

• Document Control
• Management Responsibility
• Resource Management
• Realization of the Product
• Monitoring, Measurement and Improvement

Partnering with an experienced and recognized registrar, such as LNE/G-MED, can be one of your most important steps to ensure a smooth, efficient audit process, obtain valuable feedback on your quality processes and convey credibility to your customers, business partners and regulators.

Advantages

LNE/G-Med has the necessary expertise and experience to provide a fair, thorough assessment under ISO standards which holds up to tough CMDCAS regulatory scrutiny. And we can combine audits (such as CMDCAS and CE Marking) to save you the time and cost of multiple audits. You also benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team

*Source: The Medical Device Market: Canada; Epsicom Research; 1/31/10