Notice: Guidance Document – Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations

November 21, 2018
Our file number: 18-117169-555

Health Canada is pleased to announce the release of the guidance document - Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations.

This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in recognizing Auditing Organizations under the MDSAP.

The MDSAP is a program designed to allow third-party auditing organizations to audit the quality management system (QMS) of medical device manufacturers in a way that will be accepted by the regulatory authorities of the five participating countries (Canada, Australia, Brazil, Japan, and the U.S.). Health Canada is currently transitioning to the MDSAP program.

The MDSAP will replace the previous 3rd party auditing program, the Canadian Medical Device Conformity Assessment System (CMDCAS), in 2019. Consequently, this new guidance document will replace the May 2000 document, Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS) – Quality Systems by January 1, 2019.

This guidance document is effective January 1, 2019.

Questions or concerns regarding this guidance document should be directed to:

Quality Systems Section
Medical Devices Bureau
Holland Cross, Tower A
11 Holland Avenue Suite 511
Ottawa, Ontario
K1A 0K9
Phone: (613) 952-8250
Fax: (613) 954-7666
Email: qs.mdb@hc-sc.gc.ca