Initial Importer System Content
Document Control Procedure (Simplified)
Change Control Procedure (Simplified)
Medical Device Reporting (MDR)
Remedial Action / Recall Procedure
Complaint Handling Procedure
Complaint Trending Procedure
Product Hold Procedure
Supplier Management Procedure
Management Review Procedure
Training and Job Descritptions
Internal Audit Procedure
Corrective and Preventative Action
Includes Related Forms
Per FDA definition the term Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
Initial importers are also subject to Medical Device Reporting (MDR) under 21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and nonMDR events) must be forwarded to the manufacturer. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.
Industry trends would suggest that initial importers may soon be subject to increased scrutiny as part of an FDA effort to gain greater control over the thousands of initial importers in the U.S. In recognition of this compliance need GPMG developed a quality system product specifically tailored to Initial Importers operations.
GPMG understands the simplified organizational structure of most Initial Importer operations and crafted the system to be the least burdensome approach to compliance.The GPMG Initial Importer Quality System is a great tool to gain FDA compliance with minimal resource requirements.