Medical Device Single Audit Program
This is a program that allows an Auditing Organization to carry out a single audit of a medical device manufacturer’s Quality Management System (QMS) that satisfies the relevant requirements of the following regulatory authorities:
Australia
Therapeutic Goods Administration (TGA)
Use the MDSAP audit report as part of key evidence that is assessed for compliance with medical device market authorization requirements.
Brazil
Agência Nacional de Vigilância Sanitária (ANVISA)
Utilize reports and outcomes as an important input on pre-market and post-market assessment procedures, providing key information that support regulatory technical evaluation.
Canada
Health Canada (HC)
In Canada, manufacturers who wish to sell Class II, III, and IV medical devices are required to provide an ISO 13485 quality system certificate, as evidence of compliance to the Canadian Medical Device Regulations (CMDR). Currently, this certificate can only be issued by a MDSAP Auditing Organization.
USA
Food and Drugs Administration (FDA)
The FDA accept MDSAP audit reports in place of FDA routine inspections (Except for "For Cause" or "Compliance Follow-up" inspections). In addition, MDSAP does not apply to any pre-approval or post approval inspections for Premarket Approval (PMA) applications, nor to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.
Japan
Ministry of Health Labor and Welfare (MHLW) & Pharmaceutical and Medical Devices Agency
Officially joining the MDSAP pilot in June 2015, Japan uses the MDSAP report in both premarket and periodical post market assessment procedures.
In addition to the members above, the European Union (EU) and World Health Organization (WHO) are MDSAP Official Observers. The new MDSAP Affiliate Members are Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT) and the Republic of Korea’s Ministry of Food and Drug Safety.
The MDSAP audit cycle is three years, with an Initial Certification Audit, two Annual Surveillance Audits, and then a Recertification Audit.
Benefits of MDSAP
MDSAP is a program that medical device manufacturers may use to be audited once for compliance with the standard and regulatory requirements of the five countries above (or part thereof).
Key benefits include:
Incorporation of ISO 13485 as part of MDSAP
Reduction in time & resources normally dealing with individual audits from the five countries
Reduction in cost (compared to independent audits)
Transparency
Predictable audit schedules
Entry to multiple markets
MDSAP vs ISO13485 Checklist
Use our specifically designed checklist to ensure that requirements for both align for you to take your medical devices to market as quickly and safely as possible.
Grading of MDSAP Nonconformities
For manufacturers, probably the biggest concern during any audit is what nonconformities (NC) will be issued.
The MDSAP Grading System (based on GHTF/SG3/N19:202) was created to clarify this and address inconsistencies within tradition audit grading approaches that use “Major Findings” or “Opportunity for Improvement”. It establishes objective criteria which are used to characterize the significance of any potential finding that is more easily shared and understood by the participating Regulatory Authorities.
NCs are assigned a grade between 1 and 5, which is calculated using a two-step scoring system.
Step 1: Grading Matrix
First, a 4-point NC matrix is used to determine the initial score. This is divided based on clauses of ISO 13485:2016, into two categories:
Indirect – Clauses 4.1 through 6.3, which have an indirect impact on the device’s safety and performance. This includes general documentation, quality manual(s) and resources
Direct – Clauses 6.4 through 8.5.3, which have a direct impact on the device’s safety and performance. This includes design, work environment, production, purchasing, and CAPAs
However, the frequency of occurrence of a nonconformity adds to the grade that is given. This happens when, during a specific MDSAP audit, a NC is identified within the same subclause (i.e. 8.5.2) that had a NC in the last two audits. This is because a reoccurring NC indicates a corrective action has not adequately addressed the issue.
Step 2: Escalation Rules
After the matrix grade has been determined, the score may be further increased by +1 if there is an absence of a documented process and/or if a nonconforming medical device was released.
MDSAP Post-Audit Timeline
One of the benefits of a MDSAP audit is a clear timeline of events once the audit is complete. This is shown in the graph below.
