Medical Device Single Audit Program
Meet multiple requirements with a single audit.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management systems, which also satisfies the requirements of multiple regulatory jurisdictions. These jurisdictions currently include the US (FDA), Japan (MHLW/PMDA), Canada (Health Canada), Brazil (ANVISA) and Australia (TGA).
MDSAP certification allows medical device manufacturers to be audited for compliance with the ISO 13485 standard and regulatory requirements across these markets. The mission is to “jointly leverage regulatory resources to manage efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” This enables appropriate
regulatory oversight of medical manufacturers’ quality systems, as well as promotes alignment of regulatory approaches and technical requirements based off of ISO 13485 best practices.
Any manufacturer of medical devices is eligible to undergo an assessment under the MDSAP standard, however dependent on the regulatory authority, exclusion criteria may apply. In lieu of multiple audits or inspections, the program reduces the overall number of assessments and optimizes time and resources spent on those activities.
“The TGA will take into account MDSAP audit reports when considering whether to issue or maintain a TGA Conformity Assessment Certificate. Under some circumstances a manufacturer may avoid routine TGA inspections. TGA will take into account MDSAP- audit reports when considering whether a manufacturer has demonstrated compliance with an Australian Conformity Assessment procedure.”
“RDC 15/2014 and RE 2.347/2015, ANVISA may use MDSAP audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market. Undergoing an MDSAP audit may accelerate ANVISA´s GMP certification process, which is a pre-requisite to the marketing authorization. ANVISA can also use MDSAP audits to renew ANVISA’s GMP Certificate biannually, as an alternative to an ANVISA comprehensive inspection.”
“Health Canada will operate the current Canadian Medical Device Conformity Assessment System (CMDCAS) program and the MDSAP in parallel -. – 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. Additionally, Health Canada’s intent is to implement the Medical Device Single Audit Program as the mechanism to assess regulatory compliance for quality management system requirements in Canada.”
“When an MDSAP audit report is submitted at the timing of premarket or periodical post-market QMS inspection application, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the report as a trial: 1) To exempt a manufacturing site etc.* from on-site inspection, and/or to allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.”
“U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, will accept the MDSAP audit reports as a substitute for FDA routine inspections (biennial by policy).”
The process starts with the client’s needs and expectations. DQS wants to learn about the client’s organization, its management system, size and types of operation. Together both parties will define objectives for the assessment and/or certification, including applicable standards and specifications.
DQS will provide a detailed offer for assessment and certification services, tailored to individual client needs, based on the information provided initially. A written contract will specify all relevant deliverables as well as applicable assessment and certification criteria.
A pre-audit can serve as initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects a project planning meeting provides a valuable opportunity for the client to meet the lead assessor and develop a customized assessment plan for all functions and locations involved. Both services are optional.
The assessment procedure itself begins with review and evaluation of system documentation, goals, results of management review and internal audits. During this process, it will be determined whether the client’s management system is sufficiently developed and ready for certification. The assessor will explain findings and coordinate any required activities to prepare for the on-site system assessment.
The assigned auditor team will audit the client’s management system at the place of production or service delivery. Applying defined management system standards and specifications, the assessment team will evaluate the effectiveness of all functional areas as well as all management system processes, based upon observations, inspections, interviews, review of pertinent records, and other assessment techniques. The audit result, including all findings will be presented to the client during the closing meeting. Required action plans will be agreed upon as necessary.
The independent certification function of DQS will evaluate the audit process and its results, and decide independently about issuance of the certificate. The client receives an audit report, documenting the audit results. When all applicable requirements are fulfilled the client also receives the certificate.
Either semi-annually or at least once per year, there will be an on-site audit of the critical components of the management system. Improvement potential will be identified, with a focus on continual improvement and sustained effectiveness.
A management system certificate is valid for a limited period of time, frequently for a maximum of three years. At the end of this cycle, a re-audit will be carried out to ensure the ongoing fulfillment of all applicable requirements. Subject to this fulfillment, a new certificate will be issued.
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