E-update - 12 November 2013
BSI would like to draw your attention to the MDSAP Pilot Program that is starting in 2014, that will have significant impact on your Medical Device Audits in the future.
The International Medical Device Regulators Forum (IMDRF) have recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the Medical Device Single Audit Program (MDSAP).
This global approach opens possibilities and pathways to support the development of an international initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in a Pilot Program starting in 2014.
Which Regulatory Authorities will Participate in the Pilot and What Does it Mean for Medical Device Manufacturers?
The pilot MDSAP is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
The international partners for the MDSAP Pilot starting in 2014 are:
- Australia: The Therapeutics Goods Administration TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.
- Brazil: The Brazilian National Health Surveillance Agency ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues.
- Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
- United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.
Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the Pilot Program’s Regulatory Authority Council and subject matter expert groups.
The development of the MDSAP includes the use of third party auditors much like some current regulatory audit programs, as well as regulatory inspectorates. BSI is in the process of applying for recognition as a recognised Auditing Organisation under MDSAP program. If you would be interested in being audited as part of the Pilot Program please let us know.
Where can I get more information?
Full details of the pilot and future plans can be below:
The International Medical Device Regulators Forum (IMDRF)
The Therapeutic Goods Administration (TGA) of Australia
Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
The U.S. Food and Drug Administration
Sign up to BSI Global Medical Devices LinkedIn page to receive all the latest updates, regarding this pilot and other regulatory changes occurring in the Medical Device industry:
BSI Global Medical Devices LinkedIn
How can BSI help?
If you have any questions please contact your BSI Client Manager or Scheme Manager directly.
Angie Combs, Technical Manager, Medical Devices - CMDCAS Program Manager