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Insight Report Vol. 12 No.2

FDA compliance requirements for medical device importers/distributors – You are not immune from CAPA investigations

This IR has been prepared by a recent experience mdi has had with an FDA Inspection of a Medical Device Importer/Distributor

mdi Consultants has recently assisted with an FDA inspection of an importer/distributor of medical devices. It is important to note that firms that are not involved in actual production activities of medical devices and simply purchase device from overseas manufacturers are still subject of FDA Quality System Regulations and hense, FDA inspections. These initial importers/distributors are also required to be registered with the FDA.

Major emphasis for an importer/distributor inspection was with complaint investigation and MDR filing. Even if your company has pretty good complaint records, the FDA may still comment that it is not enough to simply have good documentation. The complaint investigations must be thorough and ultimately result in finding a true root cause of the problem which can be further addressed through the CAPA system. FDA understands that CAPA’s should be handled by a device manufacturer however, they view an importer/distributor as the entity that places devices on US market so they will look for effective CAPA handling in your quality system. It does not mean you are expected to provide an actual fix but to demonstrate effective handling with the manufacturer to accomplish successful CAPA resolution. If these are the practices you are already following, it confirms your company is on the right track. If you are an importer/distributor and didn’t realize the extent of your involved in these types of investigations, you are not alone. The FDA is taking a much stronger stance on this with the greatly increased amount of imports and the number of quality problems involving these devices.

It is mostly important that all complaints, especially those involving any kind of an injury, even minor, are thoroughly evaluated and documented for a decision to file or not to file an MDR. The FDA did not say that every injury is an automatic MDR. They were in agreement with certain injury related complaints that were not filed as MDR for as long as the rationale was appropriate and well documented. So if at times you need to decide about a possible MDR, assure that your personnel have the required expertise to make such decision or enlist a help of an outside consultant.

So, initial importers/distributors who once thought that they only had to have the following procedures in their quality system were:
     Complaint handling
     MDR reporting
     Recalls
would put themselves in a very vulnerable position if they find that they are being audited. This would especially be critical if the FDA inspection was as a result of a product recall.

In terms of required SOP’s, the expectations for an importer/distributor are at the minimum: Complaint Handling and Complaint Investigations, Medical Device Reporting, Product Recall, CAPA, Document Control, Purchasing Controls (supplier evaluation), Management Review, Internal Audits and Personnel Training.

If you want more information FDA QSR/cGMP compliance for your importing/distributions operations contact mdi at info@mdiconsultants.com and ref. import/distribute.

Next Insight Report - to be announced.

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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