MDSAP Position Statement

04th, April 2019

Background: The Medical Device Single Audit Program, or MDSAP, is a means to reduce the number of surveillance Inspections by the Regulatory Authorities from Australia, Brazil, Canada, Japan and the USA. MDSAP challenges and assesses conformance to the Medical Device Regulations and Laws of the above countries, and not to ISO. While it originally started out as a voluntary program in 2014, it became mandatory in late 2017 with Canada making it compulsory to have MDSAP certificates from Jan 01, 2019.

Vitalograph position: Following significant pressure from Medical Device companies across the globe, Health Canada amended the compliance route in 2018, as regards to medical device registration in relation to MDSAP requirements. Vitalograph confirms our compliance with these requirements, including agreement with our Auditing Organization to have an MDSAP audit in Q2, 2019. While our CMDCAS ISO 13485:2016 certificate expired in Dec 2018, as per Health Canada ruling, Vitalograph can continue to ship duly registered product into Canada.

Vitalograph management will continue to ensure we are in a state of MDSAP audit readiness.