Monday, October 5, 2009

No Grace Period for Unlicensed Software

The Health Canada notice dated August 31, 2009 states, "If manufacturers previously received a Class I ruling from Health Canada, but their software now falls into Class II (as defined above), a one-year transition period will be granted to the manufacturers in order to be able to meet all the regulatory requirements outlined under section 32(2) of the Medical Devices Regulations. This transition period is effective as of the date of this notice" (August 31, 2009).

According to an official of Health Canada contacted on this date, this transition applies only to software that has previously ruled as Class I. Software that has not been classified as Class I by Health Canada is subject to licensing immediately. There is no transition or grace period. Nor are there any grandfathering provisions for patient management software currently in use.

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