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Transition to the MDSAP

The Medical Device Single Audit Program (MDSAP) uses one audit to achieve regulatory compliance in up to five countries  - US, Australia, Brazil, Canada and Japan.  The program is voluntary with the exception of Health Canada, which will require MDSAP certification by January 2019.

Oriel STAT A MATRIX can help you prepare for MDSAP.

With MDSAP, ISO 13485:2016, ISO 9001:2015, and the new EU regulations, CBs and regulators will be experiencing increased demand for their services.  Be sure to plan ahead.

Training
Understand the MDSAP requirements and how to participate in MDSAP


In our 2-day course Transitioning to the Medical Device Single Audit Program (MDSAP), you'll learn about MDSAP, what is included in an MDSAP audit, the use of the nonconformity grading matrix, and how to prepare for MDSAP participation. This course is offered in 12 cities across the US, or we can deliver it at a location of your choice. Upcoming sessions.

MDSAP Baseline Audit
Map the road ahead


Understand your current compliance level against MDSAP requirements – we’ll follow the same Process-Based MDSAP Audit Model that the Auditing Organizations (AO) will use and calculate your MDSAP audit score to identify your areas of biggest risk.

The MDSAP Baseline Audit concludes with a transition planning session. Since we are not an MDSAP-certifying AO, we can make specific recommendations for addressing findings. This session will provide you with an actionable “roadmap” to resolve any findings.

Close the Gaps
Take action


We can assist you in implementing the MDSAP Transition Action Plan. Additional support may include coaching to apply risk-based thinking, developing and reviewing MDSAP audit checklists, aligning your internal audits to the MDSAP process, assessing if your products are registered properly in the participating countries (Chapter 2), and meeting the MDSAP reporting requirements (Chapter 4). 

Prepare for the Auditing Organization's Audit
Final dress rehearsal


You’ve prepared, and now it’s time for a final run-through before the real event. In this Preassessment Audit, our independent reviewers will follow the Process-Based MDSAP Audit Model and scoring rubric to help you identify any issues before your MDSAP certification audit. This gives you time to plan and implement corrective actions, and prepares you for what an actual AO certification audit will feel like.

 

What is MDSAP?

The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs).

Currently, five RAs are participating in the program:

  • Australian Therapeutic Goods Administration (TGA)
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada
  • MHLW/PMDA (Japan)
  • US Food and Drug Administration (FDA)

A three-year MDSAP pilot concluded in December 2016, and the program moved into its operational phase in January 2017.  

Is MDSAP required?

The program is voluntary apart from Health Canada, which will require MDSAP certification by January 2019. 

All manufacturers who sell in Canada must transition from CMDCAS to MDSAP before January 1, 2019 to meet the requirements of the Canadian Medical Devices Regulations. Learn more.

What are some of the benefits of MDSAP certification?

  • Leverage a single audit to meet the needs of multiple regulatory jurisdictions.
  • Promote the alignment of regulatory approaches and technical requirements.
  • Improve regulatory audit consistency, predictability, and transparency.  

How does MDSAP work?

MDSAP uses recognized third-party auditors – Auditing Organizations (AOs) – to conduct a single quality management system audit that satisfies the requirements of multiple regulatory authorities. The MDSAP audit model covers the requirements of ISO 13485 plus Good Manufacturing Practice (GMP) requirements for each applicable regulatory authority. For example, for the US, the GMP requirements of 21 CFR 820 are addressed; for Brazil, the GMP requirements of RDC ANSVISA 16/2013 are applied.

Manufacturers need only comply with the regulations from the jurisdictions where they sell their products. During an MDSAP audit, the AO will audit only the country-specific regulatory requirements for the MDSAP participant countries (United States, Brazil, Australia, Canada, and Japan) in which you sell your devices.

What can I expect from an MDSAP audit?

The MDSAP audit follows the process approach in a top-down direction. The audit sequence has four primary processes: 1) Management; 2) Measurement, Analysis, and Improvement; 3) Design and Development; and 4) Production and Service Controls. There are also three supporting processes: 5) Purchasing; 6) Device Marketing Authorization and Facility Registration; and 7) Medical Device Events and Advisory Notices Reporting.

  • Initial certification audit: This is a complete audit of a manufacturer’s QMS. It is conducted in accordance with the requirements of ISO/IEC 17021 in two separate stages:
    • Stage 1 audit activities are intended to evaluate QMS documentation and the extent of a manufacturer’s preparedness to undergo Stage 2 audit activities.
    • Stage 2 audit activities assess actual compliance of the QMS with the requirements of ISO 13485 and other requirements of the MDSAP-participating regulatory authorities.
  • Surveillance audits: In the two years following an initial MDSAP certification audit, a surveillance audit is conducted to determine compliance with MDSAP QMS requirements. These audits do not include the review activities that are part of an initial certification audit and do not need to address all MDSAP requirements that are part of Stage 2 activities. Surveillance audits should assess any changes in the manufacturer’s products or QMS processes since the initial certification audit was conducted.
  • Recertification audit: Recertification audits are conducted in the third year following the initial certification audit. These are intended to evaluate a manufacturer’s QMS for continued suitability and ability to meet QMS requirements under the MDSAP. These audits employ more precise sampling, and typically take less time than initial certification audits.

How do I participate?

MDSAP audits may be performed during the scheduled annual visit or during a special visit. To participate, confirm that your Notified Body (NB)/Certified Body (CB) is approved to participate in the program and be sure to let them know of your intent to be audited to MDSAP requirements. 

Select a course below to learn more or to register.
 
Course Name Public On-site
New!   Transition to the Medical Device Single Audit Program (MDSAP)

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

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