MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)
On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to provide updates and feedback on the implementation status of the Medical Device Single Audit Program (MDSAP).
This article provides a brief overview on how each of the participating regulators use MDSAP and the key take-aways from each regulator.
United States FDA:
How FDA uses MDSAP:
MDSAP audit reports are acceptable as a substitute for FDA routine inspections.
However, MDSAP audits will not substitute certain types of inspections, including:
- For Cause
- Compliance Follow-up
- Pre-approval or post-approval
- Compliance with Electronic Product Radiation Control (EPRC) Regulations
- Participation in MDSAP has grown exponentially in 2018. From 777 Manufacturers at end of 2017 to 2,700 manufacturers by the end of 2018.
- FDA use of MDSAP has generated a lesser auditing burden for multi-nationals.
- Questions continue with regards to the ability of the FDA to cancel surveillance audits by using MDSAP Certificates. Some companies indicated for cause audits have been replaced with surveillance audits to circumvent the MDSAP Certificate. FDA acknowledged that there is an adoption curve being implemented to adjust the auditing practices for MDSAP-certified companies and encouraged companies to contact FDA central offices to resolve any auditing questions.
How Health Canada uses MDSAP:
- MDSAP Audit Certificates replace CMDCAS certificates.
- Health Canada uses MDSAP certificates as evidence of conformity to Medical Devices Regulations sections 32(2)(f), 32(3)(j) and 32(4)(p).
Canada has made it mandatory to obtain an MDSAP certification by January 1st, 2019 in order to continue to supply products to Canada. However, in April of 2018 they announced two mitigating measures to address the growing concerns on timelines to certify companies and the significant burden that the MDSAP auditing program represents for smaller firms.
- To date, roughly 75% of Manufacturers had transitioned to MDSAP. About half have undergone the transition, and the remaining have submitted documentation of their plans to transition during 2019.
- Health Canada has provided guidance on the documentation requirements needed to submit prior to Dec 31st, 2018 where a company has not fully implemented the transition to MDSAP. Many manufacturers expressed confusion on providing objective evidence of their plans to transition to MDSAP.
- One point of clarification made was that Health Canada only requires the legal manufacturer to comply with the MDSAP mandate.
How PMDA uses MDSAP:
- PMDA accepts MDSAP audit reports to reduce the burden on medical device manufacturers.
- PMDA may perform an off-site inspection instead of an on-site inspection, or reduce the documentation requirements for on-site inspections when an MDSAP audit report is supplied.
- Japan is also working to harmonize with ISO 13485 QMS requirements, however they recognize that the Japan-specific requirements will need to be significantly changed to make this happen. They confirmed that the intention is to reduce the Japanese requirements.
- PMDA envisioned the Regulatory Exchange Platform REP (the centralized shared database between MDSAP participating regulatory bodies) will be a comprehensive solution for communication with all the economic operators (MAHs included) and to streamline the communication process.
How TGA Uses MDSAP:
- MDSAP has been used to establish the framework for the TGA to recognize regulatory approvals from the EU, USA, Canada and Japan in order to reduce duplication of regulatory assessments.
(To learn more visit our blog dedicated to this ground-breaking announcement. )
- TGA announced their continued efforts to harmonize with the EU MDR, with Australian changes to be implemented prior to the end of the EU MDR transition period – 26 May 2020
- 20 MDSAP Certificates have been submitted to date to support ARTG applications.
- 108 TGA on-site audits have been postponed pending the availability and review of MDSAP audit report.
How Brazil uses MDSAP:
- MDSAP Audit Certificates replace Brazilian GMP certificates.
- ANVISA uses MDSAP certificates as evidence of conformity to RDA no 16/2013 requirements.
- Address main issues with apparent double taxation of manufacturers using MDSAP for GMP certification. Announced that they are working on a revision of the internal procedures for use of the MDSAP Audit Report in the GMP certification process.
- Participating cites in MDSAP are now 200, a 900% increase from the end of the MDSAP pilot program.
- There have been 87 BGMP Certs issued based on MDSAP Audit Reports thus far.
- The World Health Organization, WHO also participated in the forum and confirmed that they are fully recognizing MDSAP certifications. They did comment that special requirements for WHO target demographics should be accounted for in the design and technical documentation of medical products.
- FDA dispelled any rumors that MDSAP would be a requirement for the US in any foreseeable future.
- The announcement of TGA working to “align wherever appropriate” with EU MDR/IVDR, raised concerns on the issues currently expected in Europe for up-classification and clinical requirements of products with a long-standing history of use.
- Observing countries are expected to introduce the use of MDSAP to reduce auditing burden for manufacturers.
- The grading scheme for Nonconformities (according to GHTF/SG3/N19) used in MDSAP continues to be closely evaluated. Special attention was allocated to the basis for repeat occurrence observations and for the delineation between direct and indirect impact to QMS observations.
- All bodies recognized the huge gap in manpower for Auditing Bodies that are authorized or recognized to do MDSAP certification.
Another noteworthy update was the efforts from FDA to harmonize QSR requirements with ISO 13485, with a plan to issue the proposed rule by Fall 2019:
“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacturer, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”
For further reading, the presentations used during the event can be found here: https://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/
Final thoughts and conclusion:
During the entire program, participating companies expressed satisfaction with the program and commended the efforts done by these agencies to provide an international program for Quality System Auditing.
An outstanding question that the agencies recognized is to increase the benefits of participation in MDSAP for small to medium-sized companies that would otherwise not be audited as much by these participating regulators. They expressed interest in considering how to follow suit with Australia’s TGA, which has allowed MDSAP to be used as a conduit for market registrations.
In our opinion, this would make the program even more attractive for those companies who are still evaluating the pros and cons to participating in this innovative program.
As with any new program, the MDSAP program will continue to mature and initial adopters will have to rely heavily on interpretation and overall QMS experience. If you are thinking of implementing changes to your QMS and pursuing MDSAP certification, we can help! We have lead companies through the pilot program and current program and can help orchestrate a seamless and well-informed implementation program to assure you achieve the efficiencies that this program aims to deliver.
Looking to fly south for warmer weather? We have the skills in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)