This article summarizes the current status and updates on the Medical Device Single-Audit Program (MDSAP) Pilot that began in 2014 and will be fully implemented in 2017.
The Medical Device Single-Audit Program (MDSAP) Pilot (http://bit.ly/MDSAP) is a new international effort to harmonize the inspection and auditing of medical device manufacturers in a single annual audit to be conducted by third-party certification body auditors. The program is the result of the efforts by the International Medical Device Regulators Forum (IMDRF). The program satisfies the requirements of four regulatory bodies:
- US Food & Drug Administration (FDA)
- Brazilian National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada (HC)
- Australian Therapeutic Goods Administration (TGA)
Japan will become the fifth, full member of the pilot program this summer. Several of the European Notified Bodies are actually conducting the MDSAP audits, and it is expected that Europe will also join the MDSAP when the program is fully implemented in 2017.
FDA will accept the MDSAP audit reports in lieu of routine Level 1 and Level 2 inspections. However, these audit reports will not replace “For Cause” FDA inspections or Level 3 follow-up inspections by the FDA. MDSAP audits will not replace pre-approval inspections for 510(k) or PMA submissions either.
ANVISA will use MDSAP audit reports as part of the pre-market and post-market assessment processes. ANVISA will also accept audit reports in lieu of the initial ANVISA audit. This is critical because there is an average backlog of 3 years for initial inspections.
Health Canada intends to replace the existing CMDCAS certification program (http://bit.ly/CMDCAS) with MDSAP as the method of verifying that Health Canada’s quality management system requirements are met. This is another reason why only registrars recognized by Health Canada were invited to apply for participation in the MDSAP pilot.
Australia’s TGA will use MDSAP audit reports as an input to decisions for issuing market authorization unless the device excluded or exempted, or current policy prohibits the use of these audit reports. In addition, the Australian TGA recently became Health Canada’s 15th recognized registrar (http://bit.ly/RecognizedRegistrars).
Japan’s Ministry of Health, Labor & Welfare (MHLW)
MHLW is an official observer and active participant in the MDSAP pilot. MHLW becomes a full member this summer and already contributes subject matter experts. In addition, amendments to the Japanese Pharmaceutical Affairs Law (JPAL) were approved in November 2013 and launched on November 25, 2014 (http://bit.ly/JPAL-New-Act).
The primary mission of MDSAP is to leverage resources of the collective regulatory bodies to more efficiently monitor device manufacturers. Sharing regulatory reports will decrease the total number of audits required by regulators, and manufacturers that participate in the pilot will help shape the ultimate policies. The FDA posted four new documents on the MDSAP pilot describing how the five participating countries participating in the pilot will use the audit reports:
- Participation in MDSAP Pilot (http://bit.ly/MDSAP-Participation)
- MDSAP Frequently Asked Questions (http://bit.ly/MDSAP-FAQs)
- List of Eligible Auditing Organizations for MDSAP (http://bit.ly/MDSAP-Auditors)
- FDA Voice Blog (http://bit.ly/MDSAP-FDAVoice)
On January 20th, the FDA released an update regarding the Medical Device Single-Audit Progream (MDSAP) Pilot. If you signed up for the CDRH mailing list (http://bit.ly/CDRH-Subscribe), you might have received this important update. Here are some additional resources:
- http://bit.ly/IMDRF-MDSAP – Presentation by Kim Trautman of FDA
- http://bit.ly/imdrf-mdsap – IMDRF Webpage
- http://bit.ly/MDSAP-FDA-Resources – FDA Resources
- http://bit.ly/MDSAP-Documentation – Procedures & Forms
How to Apply for MDSAP Pilot
If you are interested in applying for participation in the pilot, you might consider contacting one of the three largest Notified Bodies that are participating in the pilot:
- Tony Rizzo at BSI (Anthony.Rizzo@bsigroup.com) – http://bit.ly/MDSAP-BSI
- Gary Minks at TUV SUD (email@example.com) – http://bit.ly/MDSAP-TUVSUD
- Bruno Samuel at SGS -(Bruno.Samuel@sgs.com) – http://bit.ly/MDSAP-SGS
The investment in training and resources to support this pilot is significant. Therefore, you can expect participation in MDSAP upon full implementation to only include the largest certification bodies.
If you are interested in more details about the Medical Device Single Audit Program, please read the full-length version of this article (http://bit.ly/MyBoneZoneArticles).
This post was adapted from an article that originally appeared in BONEZONE®. The content is revised and republished with permission from ORTHOWORLD®. www.orthoworld.com.