January 16, 2015
Our reference number: 14-115035-931
Health Canada would like to invite medical device manufacturers to participate in the MDSAP Pilot. They are encouraged to consider entering the program as experience gained during the pilot will be important in optimizing the efficiency of the regulatory quality management system audit process.
The MDSAP pilot enables medical device manufacturers to have an authorised Auditing Organization under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of those medical device regulatory authorities participating in the pilot program.
The Medical Devices Single Audit Program (MDSAP) pilot was launched on January 1, 2014 for a period of three years. It is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Agŕncia Nacional de vigilÔncia sanitßria (ANVISA ), Health Canada and the United States Food and Drug Administration (FDA). Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers in the pilot.
The MDSAP Pilot audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the requirements for a quality management system for medical devices derived from; ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes, the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Quality System Regulation (21 CFR Part 820), and other specific requirements of medical devices regulatory authorities participating in the MDSAP Pilot program including registration, licensing, advisory notices or recalls and mandatory problem reporting.
The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP Pilot. The program does not add any new requirements to existing requirements from ISO 13485:2003 or from the medical device regulations in relation to quality management system requirements of the participating Regulatory Authorities.
Health Canada will operate the current Canadian Medical Device Conformity Assessment System (CMDCAS) program and the MDSAP in parallel during the three year pilot. During the Pilot, Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for the purpose of obtaining a new (or maintaining an existing) Class II, III or IV medical device licence, pursuant to section 32 of the Regulations.
Upon successful completion of the pilot, Health Canada's intent is to implement MDSAP as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
Health Canada is currently developing a transition strategy from CMDCAS to MDSAP. MDSAP would therefore replace the CMDCAS program, regardless of whether a manufacturer intends to market only in Canada (in which case only Health Canada specific regulatory requirements would be assessed for the purposes of issuing a certificate).
Health Canada is committed to working with the Standards Council of Canada, recognized third party auditing organizations ("Registrars") and medical device manufacturers to ensure the smooth operation of both programs during the pilot and the subsequent transition to MDSAP.
During the MDSAP Pilot, all Auditing Organizations currently recognised under CMDCAS program are invited to apply for authorization to participate in the MDSAP Pilot by submitting an MDSAP application. The list of Registrars recognized by Health Canada can be found on the Health Canada website. These Auditing Organizations (recognized Registrars) undergo an application review, stage 1 assessment, stage 2 on-site assessment, and, if applicable, on-site assessment at their critical locations, and successfully resolve any identified deficiency will be authorized to perform any MDSAP Pilot Audits. The participating Regulatory Authorities will decide whether to officially recognize Auditing Organizations upon completion of the MDSAP Pilot. Additional auditing organizations may apply for recognition under MDSAP following the successful conclusion of the pilot.
Medical device manufacturers interested in the program should contact the Auditing Organization of their choice to determine if they are - or when they expect to be - authorized to perform MDSAP Pilot audits.
For documents specific to the MDSAP pilot, these are currently hosted on the US FDA website.
Questions on the MDSAP may also be directed to: QS_MDB_HC@hc-sc.gc.ca