The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device regulatory authorities in...
HC Extends Premarket Review E-Submission Program to Class III Devices
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.