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Medical Devices Regulations

Version of section 68.34 from 2023-02-22 to 2024-01-02:

  •  (1) If a new or modified quality management system certificate is issued in respect of a COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.

  • (2) Subsection (1) does not apply if the manufacturer includes the new or modified quality management system certificate in an application to amend the authorization that is submitted under section 68.14.

  • SOR/2023-19, s. 7

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