MDSAP
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What is MDSAP (Medical Device Single Audit Program)?
MDSAP is a Medical Device Single Audit Program that allows the conduct of single regulatory audit of medical device manufacturer’s QMS that satisfies various regulatory jurisdiction. This program was developed by a group of medical device regulators, the IMDRF, to allow third-party auditors to conduct this single audit of medical device manufacturers which covers ISO 13485:2016 and respective regulatory requirements.
MDSAP is a mechanism for producers of medical devices to have their compliance with the standards and laws of up to five distinct medical device markets, including Australia, Brazil, Canada, Japan, and the United States, audited once. The goal of MDSAP is to make it possible to conduct a single regulatory audit of a medical device manufacturer’s quality management system.
Are you preparing for the Medical Device Single Audit Program (MDSAP) audit? then click here to know more about MDSAP Audit Process
Regulatory Authorities Included in MDSAP
- Australia (TGA: Therapeutic Goods Administration of Australia)
- Brazil (ANVISA: Brazil’s Agência Nacional de Vigilância Sanitária)
- Canada (Health CANADA)
- Japan (MHLW: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency)
- USA (FDA: Food and Drug Administration)
The Benefits of MDSAP Certification
- Timesaving and efficiency
- Clarity and transparency
- Reduces the number of audits and inspections
- Reliable audit schedule
MDSAP and ISO 13485
MDSAP has more stringent requirements than ISO 13485. ISO 13485 and MDSAP are two different programs with similar requirements. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO 13485 MDSAP standards look to ensure that medical devices are manufactured to strict quality requirements. Companies that participate in the MDSAP program must undergo an audit to ensure compliance with both regulatory and ISO 13485 requirements in order to profit from the program.
What Is the Criteria That Must Be Achieved for the MDSAP to Be Considered Successful?
A strategy to acquire data for “proof of concept” of the MDSAP has been devised by the MDSAP Subject Matter Experts Working Group. For the purpose of evaluating the program’s progress, the plan includes eight performance metrics. The requirements concern audit reports and non-conformities, the audit methodology, the number of audits required, auditing organizations, and manufacturers. For each indication, a method of data collection, a sampling technique, an analytic technique, and goals were established. The MDSAP program has been proven to work.
Our Role in MDSAP Certification Process
- Defining the goals: To start with the first step we discuss with you about the company and the benefit of MDSAP certification. You will receive a specific offer tailored to the need of your company or organization
- Project planning: project planning is the step where we do a pre-audit, which helps us to identify the improvement potential of QMS in advance. This pre-audit meeting helps us in planning and scheduling the audit procedures.
- QMS Quality Management System Assessment: while assessing this step we guide and provide training to our clients to implement QMS as per the required regulations and we also help them in the creation of documents.
- System evaluation: You acquire your MDSAP certificate if all requirements are satisfied and the assessor’s recommendation for certification is confirmed.
For free consultation Contact us now. The cost for the MDSAP certification depends on the country-specific requirements that need to be assessed during the audit.
FAQs
What is the difference between ISO 13485 and MDSAP?
ISO 13485 and MDSAP are two different programs with similar requirements, but they do not duplicate each other. MDSAP has the more stringent requirements of the two, and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP.
What countries require MDSAP?
Make use of the MDSAP if you are a manufacturer of medical devices. In this special programme for medical devices, which includes the US, Canada, Brazil, Australia, and Japan, you can submit for a single evaluation of your quality management system (QMS).
Does FDA recognize MDSAP?
MDSAP audit reports are accepted by the Food and Drug Administration (FDA) in place of FDA Establishment Inspection Reports (EIRs).
What is the objective of MDSAP?
It is a regulatory auditing programme that four countries initially created cooperatively. MDSAP is exceptional in that it enables a medical device maker to conduct a single quality management system audit to meet the standards of all involved regulatory authorities.
What is MDSAP for medical devices?
The Medical Device Single Audit Program allows an Auditing Organization authorised by MDSAP to perform a single regulatory audit of a manufacturer of medical devices that complies with the pertinent specifications of the regulatory bodies taking part in the programme
What is the audit cycle of MDSAP?
The MDSAP is built around a three-year audit cycle, starting with a Stage 1 and Stage 2 audit of the manufacturer's QMS. Audit of Partially Surveillance in each of the ensuing two years. A thorough re-audit, also known as a recertification audit, is performed in the third year