The downside of MDSAP is that a bad inspection would immediately raise red flags and compliance problems across all IMDRF member nations. The U.S. Food and Drug Administration, for example, plans to base Warning Letters on MDSAP audits that turn up significant deficiencies, with no requirement for an inspection by the FDA itself or a Form 483 inspection report. The rollout starts with the 14 auditing organizations recognized by the Canadian Medical Devices Conformity Assessment System, most of which are also notified bodies. These entities are eligible to apply for recognition as MDSAP auditors in January. Devicemakers will be able to apply to participate in the MDSAP pilot in June.
Pilot Participation Urged
Kimberly Trautman, Associate Director of International Affairs at CDRH and Chair of IMDRF’s MDSAP working group, outlined the pilot at FDAnews’ Eighth Annual Inspections Summit in Bethesda, Md., late last month. She urged devicemakers to participate in the pilot.
Though the audit will take several days longer than, say, a routine FDA inspection, to incorporate each nation’s individual requirements, successfully completing the MDSAP audit has a major benefit: Brazil’s Anvisa will accept the audits to fulfill registration requirements. Currently, Anvisa has a backlog of more than five years for conducting audits on its own (see related story). Trautman said IMDRF will draw on lessons from the pilot to refine MDSAP.
“You can participate now and be part of the solution, or wait and get what you get,” she said. “Like any start-up company, which is what this is, we’re going to live, we’re going to learn and we’re going to have to adjust, but at least we’re getting it out there.”
To ensure that the four regulators — the FDA, Health Canada, the Therapeutic Goods Administration and Anvisa — are conducting assessments and reviews in a similar fashion, each has tweaked its quality management system, with new manuals, procedures and controls specifically designed for MDSAP, Trautman said.
The four regulators in the pilot all formally announced the program in October. Regulators in the EU and Japan, which are also IMDRF members, will not participate. Trautman noted that, in the EU, cooperative agreements with foreign regulators must be approved by all 28 member states, making them difficult to achieve. She stressed that there are no conflicts about the single audit program. Japan is considering incorporating IMDRF’s requirements for third-party auditors into proposed legislation, she said. Trautman added that Health Canada plans to make single audits voluntary during the pilot, but will then switch from CMDCAS to MDSAP and make them mandatory.
REFERENCE: FDA News; International Medical Device Regulatory Monitor; November 2013, Vol. 21 No. 11