Medical Device Regulatory Submissions
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Health Canada has adopted a risk-based classification system which is consistent with that of other countries. Canadian medical device risk-classifications are based on the application of the risk classification rules outlined in the Medical Device Regulations. It is important to note that a product may have a different risk rating in Canada than assigned in other regulatory jurisdictions. It is also important to note that some products regulated as medical devices in other countries, may in fact be drugs or natural health products in Canada, based on the definitions that are found in the Food and Drugs Act (FDA). The first stage of assessment is to work with a DSA Regulatory Affairs Consultant to assess risk classification for the Canadian market. Here are some examples: Risk I
All risk II, III, and IV medical devices must be registered with Health Canada prior to their sale in Canada. A DSA Regulatory Affairs Consultant will handle all aspects of medical device submission preparation and on-going contact with the Medical Devices Bureau to follow through on product approvals. We can spearhead the entire registration project or just handle specific components of the submission process for you, such as a Quality Control Review of submissions prepared by your own staff. DSA Consultants can handle the following types of regulatory submissions to Health Canada’s Medical Devices Bureau:
A DSA Regulatory Affairs Consultant can also handle the associated review of product labels to ensure compliance with Canadian labelling regulations (package labels, cartons, and product inserts). Our medical device regulatory affairs services include pre-approval label reviews or label development to guide you on compliance with Canadian Regulations and advise you on changes to labelling which will help maximize claims and/or expedite product approvals. DSA also offers post-approval label reviews to ensure compliance with the marketing authorization or to help you determine if supplemental filings are required to support your proposed changes to the approved label. Contact us today to find out how we can help you spearhead your registration projects. To receive our free white paper on marketing a healthcare product in Canada, please click here. |
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