Starting January 2014 Health Canada will be participating in a pilot program by launching the Medical Device Single Audit Program (MDSAP)together with the Australian Therapeutic Goods Administration of Australia (TGA), the Brazilian Nacional de vigilancia sanitaria (ANVISA) and United States Food and Drug Administration (FDA).
This program is intended to provide similar assessment system as the current (CMDCAS) which has been adopted by Health Canada for number of years now.
Health Canada will continue to operate the current (CMDCAS) as well as the new (MDSAP) for period of three year pilot program. During the pilot the certificates generated by registrars under MDSAP will be used instead of (CMDCAS) until the three year pilot which and successful completion of the pilot the (MDSAP) will replace the (CMDCAS), and (CMDCAS) will no longer will be used for assessment of the quality systems.
Under this program the manufacturers will benefit from a single audit program that meets the requirements of multiple countries. This will reduce the number of inspections faced by medical device manufacturers which a present cause significant disruption and cost to business operations while at the same time maintaining appropriate regulatory oversight.
FDA Video Presentation on MDSAP:
FDA Slide Presentation MDSAP: