Did you already start the transition to Medical Device Single Audit Program (MDSAP)? The clock is ticking!
October 18, 2018

As of January 1st, 2019, Health Canada will terminate the Canadian Medical Devices Conformity Assessment System (CMDCAS) program and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted. To ensure a smooth process, the Canadian Authorities have recently published a Frequently Asked Questions (FAQ) document to provide further clarification on the Transition Plan, as well as the different scenarios available and their respective requirements to maintain Medical Devices Licenses active.

With the aim of promoting Medical Device industry expansion into different markets, the Medical Device Single Audit Program (MDSAP) was initially developed to enable an efficient, effective, and sustainable regulatory oversight of Medical Device manufacturers’ Quality Management Systems (QMS) which satisfied the requirements of multiple regulatory jurisdictions. This way, Medical Device manufacturers would be audited only once for compliance with the standard and regulatory requirements of up to five different Medical Device markets: Australia, Brazil, Canada, Japan and United States.

According to the program premises, MDSAP Audits are to be conducted by Auditing Organizations (AO), which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements. However, most of candidate Auditing Organisations are either still being evaluated for recognition against the current MDSAP audit criteria or gathering auditing experience by executing the MDSAP audit models and processes.

Other Competent Authorities involved in the program, such as the Therapeutic Goods Administration (TGA) in Australia, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW), the Brazilian Agência Nacional De Vigilância Sanitária (ANVISA), and the U. S. Food and Drug Administration (FDA) have recently updated their lists of authorized and formally recognized Auditing Organizations to conduct QMS audits under the Medical Device Single Audit Program (MDSAP) and already accept MDSAP audit reports as a substitute for routine Agency audits or inspections for selected types of devices. Thus, Medical Device manufacturers may be required further assessment in addition to the MDSAP Certification to fulfil the local requirements.

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