The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.
MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.
MDSAP audits can be performed by a recognized MDSAP AO, such as BSI. We have been active from the inception of the MDSAP pilot phase and have now completed significant numbers of MDSAP audits, predominantly from world-leading medical device manufacturers.
Time for your MDR application is now
According to Amending Regulation (EU) 2023/607, if you are transitioning to the MDR, you will be able to benefit from extended validity of your directive certificates for legacy devices if some conditions are met.
Among these, by 26 May 2024 you have to put in place an MDR compliant QMS and lodge a formal application with a Notified Body for MDR Conformity Assessment.
MDSAP should be considered for companies based globally, if they wish to export products into the countries participating, as described below. The five RAs involved with MDSAP have made the following statements on how they will utilize MDSAP reports:
Australia
The Therapeutics Goods Administration (TGA) uses an MDSAP audit report as part of the evidence that it has assessed for compliance with medical device market authorization requirements, unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.
The Brazilian National Health Surveillance Agency ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and postmarket assessment procedures. It provides, when applicable, key information that is expected to support regulatory technical evaluation on these issues.
Health Canada Health Canada (HC) will ONLY accept MDSAP for manufacturers who market their devices in Canada. Therefore, manufacturers wishing to place a product on the market in Canada need to have MDSAP Certification issued by an AO.
The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both pre-market and periodical post-market audits under regulations in Japan.
U.S. Food and Drug Administration’s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Moreover, the MDSAP program would not apply to any necessary pre-approval or post-approval inspections for Pre-Market Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f) (5)) concerning the classification of a device.
BSI è un AO pienamente riconosciuto. Abbiamo sostenuto il progetto pilota MDSAP e conduciamo audit da settembre 2014. Abbiamo riscontrato un aumento dell'interesse e delle richieste da parte dei fabbricanti. Il feedback sui vantaggi di MDSAP è stato estremamente positivo.
BSI comprende le sfide specifiche che i fabbricanti di dispositivi medici devono affrontare e l'importanza di portare prodotti innovativi e sicuri sui mercati globali. Garantire la resilienza e la trasparenza delle autorizzazioni normative è fondamentale per mantenere un vantaggio competitivo.
Dimostriamo questo impegno attraverso
oltre 200 valutatori MDSAP in tutto il mondo
oltre 240 valutatori QMS ISO 13485 in tutto il mondo
esperti di prodotto e revisori interni
accesso diretto a un team di specialisti tecnici e clinici