Oct 26, 2011
Starting November 1, 2011, Health Canada will extend a pilot program requiring both paper and electronic submissions of premarket review documents for Class IV medical devices to Class III devices, as well.
According to a new HC guidance for industry, the pilot program’s extension to Class III applications are part of the regulator’s ongoing transition to accepting stand-alone electronic submissions. The guidance covers medical device license applications as well as medical device license amendment applications for Class III and IV medical and in vitro diagnostic devices. The program also applies to documents including Screening Deficiency Letter responses, Clarification Requests and Additional Information Letters associated with premarket review submissions.
The HC guidance lists file and data formatting, naming and structuring requirements and suggestions, and also requires letters of attestation from manufacturers verifying that the content of their electronic submissions matches that of their paper filings.
Electronic premarket review submissions will help expedite the device review process, HC argues, and improve data management as well.
Citing rising costs of performing medical device and pharmaceutical regulatory activities in Canada, Health Canada has announced user fee increases—some of them substantial—for medical device license
Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and