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Regulatory requirements in the EU and Canada are subject to revision.  Below you will find the most maintained, up-to-date regulatory guidance offered by the standard bodies to ensure that your path starts and follows a positive course.

European Union

Revision of the EU Medical Device Legislation.

Comprehensive source for EU regulation regarding medical devices.

Guidance documents to assist in EU regulatory compliance.

EU recognized association of organizations that provide European Authorized representative services for non-European manufacturers.

Listing of EU National Competent Authorities regarding general contact, vigilance, and clinical investigation.

Canada

Overview of legislation and guidelines for medical devices.

Canadian Medical Device Regulations

List of documents to assist in medical device and quality procedure compliance.

List of registrars recognized by Health Canada.

Global Initiatives

Forum dedicated to global medical device harmonization.