Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?

Annually and within November 1st, the manufacturer must submit a document to the Ministry:
• confirming that all information and documents provided are still valid;
• describing all changes for the information and documents provided.
If the manufacturer does not meet the disclosure requirements, the Ministry may withdraw the license. If the manufacturer suspends the medical devices sale in Canada for a certain period, the Ministry shall be informed within 30 days. If a new quality system certificate is issued or the current one is amended, the manufacturer must notify the Ministry within 30 days by sending a copy of it. Further obligations must be met as defined in Regulation SOR 98-282.