Medical Market Consultants
Managing the Business of Science™
Experience. Service. Quality.
Value of Innovative Technologies and Devices
We are at a time of unprecedented promise in the realm of medical technology. Through earlier and more accurate diagnosis, less invasive procedures and improved treatment options, medical technology is transforming health care while dramatically improving and enhancing the lives and productivity of Canadians and patients worldwide.
Significant gains in patient outcomes and improved health care system efficiencies over the long term are achieved with the safe and proven technology solutions offered by today's medical technology companies.
Discover and Explore the world of innovative technologies and devices:
Source: Copyright 2011 MEDEC - Canada’s Medical Technology Companies
Medical Devices - Overview
In Canada medical devices share many of the same regulatory requirements as in other countries. A risk-based classification system sets out the fundamental framework and the classification rules that will be the determining factor regarding submission requirements. Each country may not necessarily assign the same classification to the same product. Some products regulated as medical devices in their country of origin may be classified a drugs or natural health product in Canada.
Generally products fall into one of four (4) categories, Class I to Class IV, with the regulatory requirements increasing as a product moves up in class. As an example, a Class IV device would be a cardiac pacemaker while Class I is something as common as a toothbrush.
Spectrum MMC can assist clients in their registration activities across all risk classes. Services include:
- Assessment of risk classification
- Preparation of submissions from Investigational Testing Authorization to commercial applications (Class II-Class IV)
- Certification, registration and support
- Counsel regarding compliance issues
- Label and advertising review
- Liaison with Health Canada
- Organize and manage meetings with Regulatory Authorities
- Manage regulatory compliance issues
"We have been working with Spectrum MMC for over five years, and have always been satisfied with the professional approach, the quality of work and the value that your team has provided to our efforts, especially in our project to register SilverClear with the Health Canada's Medical Devices Directorate.
When a question comes up related to Canadian regulations or issues, we can always count on you and your team to guide us or put us in touch with the right contacts to get the information.
When we have issues with decisions taken by government officials, you are always in a position to guide us and support us in our decision to pursue the negotiations or move on."
Bernard A. Rose
Medifit Marketing Inc.