Canada medical device QA/RA blog

News and commentary on regulatory changes.

Health Canada Elaborates on IEC 60601-1 Compliance Recommendations

Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safety standards.

According to an HC official, licenses already issued for medical devices meeting requirements of the Second Edition of IEC 60601-1 will remain valid after 2012, as will licenses for devices in compliance with standards related to the Second Edition.

 New equipment, however, may have to meet Third Edition requirements—even if manufacturers already hold licenses for compliance with the Second Edition—depending on how individual provinces enforce Canada’s Electrical Safety Code.

From June 2012, manufacturers applying for significant change amendments to their device licenses previously complying with the Second Edition will be asked to update their compliance to meet Third Edition requirements, according to the official. The regulator also encourages all manufacturers to comply with the Third Edition as quickly as possible to ensure up-to-date electrical safety of their products.

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