What is MDSAP?

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 the third-party auditors to conduct this single audit of medical device manufacturers which covers ISO13485:2016 and respective regulatory requirement. 

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. 

Which 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) 

What are the Benefits of MDSAP Certification

  • Time-saving and efficiency  
  • Clarity and transparency  
  • Reduces the number of audits and inspections 
  • Reliable audit schedule

MDSAP and ISO13485

MDSAP has more stringent requirement than ISO13485. ISO 13485 and MDSAP two different programs with similar requirement. the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO13485 MDSAP standards look to ensure that medical device 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.

How Operon Strategist Help 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. 

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. 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.