by Leslie Blyakhman, Regulatory Project Director and
Tim Robinson, Regulatory Project Director
The current medical device regulatory environment is highly dynamic with changes to ISO 13485 and European regulations well underway. The latest new wrinkle is the introduction of the Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is an international initiative led by the Regulatory Authorities of the International Medical Device Regulatory Forum (IMDRF). The intent of the program is to establish a single audit system to meet the quality system audit requirements of the five Regulatory Authorities:
- Therapeutic Goods Administration (Australia)
- ANVISA (Brazil)
- Health Canada (Canada)
- US Food and Drug Administration (United States).
The principle behind the MDSAP is the use of recognized third-party auditors (Auditing Organizations) to conduct a single audit of a medical device manufacturer to satisfy the various Quality Management System requirements of the participating organizations.
How Does the MDSAP Impact My Organization?
After three years in a pilot phase, MDSAP moved into the operational phase in January 2017, when all five Regulatory Authorities choose to continue to participate in the program. The program is voluntary, with one note of critical importance: Health Canada will continue to participate in the program, but will be making a full transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP. Manufacturers intending to sell in Canada after January 1st, 2019, will need to be certified to MDSAP. Medical device license applications containing CMDCAS certificates will not be accepted after January 1, 2019.¹
What Do I Need to Consider?
Medical device manufacturers should consider which geographies they sell to and determine whether certification to MDSAP will be necessary or beneficial. If a manufacturer decides to pursue MDSAP certification, they should consider the timing of upcoming certification assessments (e.g., transition to ISO 13485:2016, new MDR/IVDR requirements) and license applications to determine optimal timing before contacting their Auditing Organization to schedule a MDSAP audit. A poorly-timed transition may result in redundant audits and additional costs.
How Can I Ensure A Smooth Transition?
Given the other major regulatory changes impacting the device industry, successfully implementing multiple new regulations while simultaneously transitioning to MDSAP will require a considerable amount of effort. Organizations should take steps to ensure their quality systems are MDSAP-audit ready. Start with a gap assessment and/or mock audit to help you determine your current state of readiness, identify areas of concern, and proactively address any identified issues. Based on the findings, design a remediation program to fill the gaps.
RCRI experts are knowledgeable in all applicable regulations, and are happy to assist you with MDSAP transition planning guidance, gap assessments, and audit services. Please contact Samantha Thrun at email@example.com or 952-224-2260 for more information.