SAI Global is authorized to conduct MDSAP audits that will satisfy the relevant requirements of those medical device regulatory authorities participating in the MDSAP program. MDSAP ended its pilot phase and became fully implemented in January 2017 in the United States, Canada, Brazil, Australia and Japan. Reference to MDSAP resources are provided at the bottom of this page.

  • Health Canada (HC) announced on December 4, 2015 under reference number 15-112791-35 their Transition Plan towards the Medical Device Single Audit Program (MDSAP) as of January 1, 2019. Only MDSAP certificates will be accepted replacing all existing CMDCAS certificates see Fig. 1).
  • The Food and Drug Administration (FDA) announced on December 17, 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 1, 2017, which will allow third parties, such as SAI Global, recognized by the MDSAP consortium to submit audit reports that FDA will utilize for routine inspections (see Fig. 1).
MDSAP is an initiative of the Therapeutic Goods Administration of Australia (TGA), the Brazilian Agência Nacional de vigilância sanitária (ANVISA), Health Canada (HC), United States Food and Drug Administration (FDA)  and Japan's Ministry of Health Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).

The MDSAP audit model was designed and developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP . The program does not add any new requirements to existing requirements from ISO 13485:2003*- ISO 13485:2016 or from the medical device regulations in relation to quality management system requirements of the participating Regulatory Authorities listed above including specific requirements for registration, licensing, advisory notices or recalls and mandatory problem reporting.

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 up to December 31, 2018. Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension by Heath Canada.

At present the MDSAP Portal is hosted on the FDA website. The essential documents to help you prepare for the MDSAP Audit are summarized below.
  1. MDSAP Frequently Asked Questions
  2. MDSAP Audit Model (Audit Checklist for ISO 13485:2016) - Companion Document with additional detail regarding each audited process
  3. Post-Audit Activities and Timeline Policy
  4. MDSAP On Line Learning Modules are located under  www.fda.org: Home / Medical Devices /Resources for You (Medical Devices) / Industry (Medical Devices) / Services Provided to Industry / CDRH Learn / Postmarket Activities / Inspections - Global Harmonization / MDSAP Learning Modules
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 audits and therefore invites you to contact us to plan your transition process between prior Q3 of 2018. Contact us regarding your MDSAP Transition at
certification.americas@saiglobal.com.





Sector Scheme Requirements MDSAP
Return to ISO 13485:2016 page
 

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