Foreign Manufacturers of Medical Devices
A foreign manufacturer is a manufacturer located outside of the United States. Foreign manufacturers must meet applicable U.S. regulations in order to import a device into the U.S.
The basic regulatory requirements include:
- Establishment registration
- Medical Device Listing
- Quality System
- Premarket Notification [510(k)], unless exempt, or Premarket Approval
- Labeling
- Medical Device Reporting.
A foreign manufacturer must designate a United States agent as a part of its initial and updated registration information. A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting. MDR regulations hold manufacturers responsible for conducting an investigation of each event and evaluating the cause of the event. Therefore, non-US manufacturers need to have a clear understanding of the MDR regulations and written procedures that describe how all requirements that apply to them will be fulfilled. Non-US manufacturers should also understand how the importer intends to comply with the MDR regulations. This is critical because some non-US manufacturers believe that only the US importer is directly responsible for submitting MDR reports. This is not the case; however, FDA has accepted the submission of an MDR report only from the importer if certain criteria are met. For example, the report includes necessary information from the manufacturer and written procedures and agreements clearly define manufacturer and importer responsibilities
Distributor
A “distributor” is defined as any person (other than the manufacturer or importer) who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper or labeling of the device or device package.
Distributor event records
Under 21 CFR 803.18(d)(1), a device distributor is required to establish and maintain device complaint records that contain any incident information, including any written, electronic or oral communication received by, or generated by, the company that alleges deficiencies related to the identity (for example, labeling), quality, durability, reliability, safety, effectiveness or performance of a device. In addition, section 803.18(d)(1) also requires that distributors maintain the information, if any, on the evaluation of these allegations in the incident record.
Device incident records must be prominently identified as such and filed by device and can be maintained in written or electronic form. Files maintained in electronic form must be backed up. It is important that non-US manufacturers know whether or not these records are being maintained for the specified period of time. That is, the regulation requires the distributor to retain copies of these records for a period of two years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater, even if the distributor has ceased to distribute the device that is the subject of the record.
Initial Importers of Medical Devices
An initial importer is defined in Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g) as an 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.
An initial importer of a medical device is required to comply with the following regulatory requirements:
- Establishment registration
- Medical Device Reporting (MDR) (21 CFR 803)
- Reports of Corrections and Removals (21 CFR 806)
- Medical Device Tracking (21 CFR 821), where applicable.
Under the MDR regulations, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions. An importer must maintain an MDR event file for each adverse event. All product complaints including MDR and non-MDR events must be forwarded to the manufacturer. Under the Medical Device Tracking regulation, certain devices must be tracked through the distribution chain.
Registration and listing
Under 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, FDA defines “initial importer.” An initial importer is 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 subject to important requirements under this regulation including the need to register their establishment and meet the medical device listing requirements that apply to them.
Device Facility User Fee
For additional information, please refer to:
Adverse event reporting
The US regulations for reporting serious adverse events are specified in 21 CFR Part 803, Medical Device Reporting (MDR). These regulations apply to importers and distributors. Under the MDR regulations, an MDR reportable event is
■ an event about which user facilities become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury
■ an event about which manufacturers or importers have received or become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury
■ an event in which the device has malfunctioned and the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Event Files
Files and records provide a critical source of evidence that importers, distributors, and manufacturers are complying with the MDR regulation. Recording events