Hi there,

Are we required to do any shipping validations prior to exporting our product? We have a 510(k), stability data etc, but was wandering if there is anything we need to on the shipping side of things and what he requirements are for that if I do. OR can we just package then up in their cases and ship?

Thanks

Requirements depend on factors such as:

- What the items are. Chemicals? Food? Pharmaceuticals?
- What standard your company is registered to. ISO? TS16949?
- Your customers' requirements
- Export/import regulations and restrictions

Are you referring to inspections?

There are a lot of things to consider but you should do some sort of packaging validation.

In 820.130 the FDA says "Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution".

There are other standards and regulations regarding packaging like ISO 13485 7.5.5 and MDD Annex I

You should research the following:

§ ASTM F1980-99, 2000 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
§ ASTM D 4169-98 Standard Practice for Performance Testing of Shipping Containers and Systems
§ ISTA 2A 2001 Partial Simulated Performance Test Procedure, Packaged-Products 150 lb. (68 kg) or Less

You have to validate that your device will be delivered to the customer safe and sterile (assuming it is sterile). You will be wanting to do a series of pre-ship and post-ship tests to prove your package will allow the device to perform correctly after shipment including Microbial Challenge or some other way of verifying your sterile barrier still functions after shipping.

I believe that ship testing is mandatory for export products. Depending on the product, a stability, sterility test must be performed on the device after exposure to ship temperatures and stress. The expectation is that your product should retain its integrity over the shelf life after exposure to shipping conditions. If you are shipping your product by sea, you have to perform the testing after exposing the product to the temperature extremes of ocean shipping; or ship the product at controlled temperatures.
The ship testing must be done after stability and sterility (if sterile device) is established at shipping temperatures and conditions. This involves shipping the product to hypothetical customer sites in the final ship container, then testing it for integrity. Alternatively, you may send the product to organizations who subject the container to a standardized amount of stress and return the container to you for testing.