SAI Global is authorized to conduct MDSAP Pilot audit that will satisfy the relevant requirements of those medical device regulatory authorities participating in the pilot program.
 

  • Health Canada (HC) announced on December 4th, 2015 under reference number 15-112791-35 their Transition Plan towards the Medical Device Single Audit Program (MDSAP) as of January 1st, 2019. Only MDSAP certificates will be accepted replacing all existing CMDCAS certificates see Fig. 1).
  • The Food and Drug Administration (FDA) announced on December 17th 2015 the termination of the Medical Device ISO Voluntary Report Pilot Program and its participation in the operational phase of the Medical Device Single Audit Program (MDSAP) as of January 1st 2017, which will allow third parties, such as SAIG Global, recognized by the MDSAP consortium to submit audit reports that FDA will utilize for routine inspections (see Fig. 1).
The MDSAP pilot was launched on January1st, 2014 for a period of three years, until January 1st, 2017. It is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Agencia Nacional de vigilancia sanitaria (ANVISA), Health Canada (HC) 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 license, 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).

SAI Global is authorized to participate and to conduct MDSAP Pilot audits and invites you to contact us to plan your transition process.

Click here to contact us regarding your MDSAP Transition
Click here for the MDSAP Sector Scheme Requirements



 

FIG 2 : Illustration of Health Canada & FDA MDSAP Transition Plans.