A VITAL GUIDE TO SHIPPING MEDICAL SUPPLIES
Shipping medical supplies can carry its own unique set of challenges and procedures. When importing and exporting medical equipment, special precaution must be used to select the right carrier. Medical equipment, pharmaceuticals, and other health care related commodities often require special attention and care due to the nature of their content. Beyond the physical handling of medical goods, it is also very important to comply to each country's unique set of rules and regulations regarding medical equipment imports. Oftentimes, there are special requirements for health care related items that must be followed to be allowed entry into a country. In this article we examine some things your team should consider when shipping medical equipment and supplies.
Medical equipment usually requires special handling and care. Unlike general goods that can be placed on a pallet, medical supplies are often more fragile in nature. It is important that your freight forwarder is familiar with how to pack, load, and transport your specific medical equipment to avoid damage in transit.
Pharmaceutical shipments may require temperature controlled environments. Some equipment may need to be crated or stored in special ways to avoid damage. Our experience in shipping medical equipment has shown that each shipment can have very different requirements from the next. Due to this, medical shipments typically take more planning and scheduling. We always recommend accounting for additional time for pick-ups, loading, and other preparation prior to boarding a plane or vessel.
TRANSIT TIME CONSIDERATIONS
Medical equipment and pharmaceutical drugs are typically shipped with urgency. It is important that your freight forwarder chooses the proper routing and carrier to meet your deadlines. Ocean shipments with transshipment points increases the level of handling of the cargo and increases the risk for cargo delays. Flights that have multiple stops will also add more cargo handling and transit time. If possible, try to book direct flights and routes without transshipments.
RESTRICTIONS AND REGULATIONS
This is probably the most important and challenging aspect of shipping medical supplies. Each country will have its own import restrictions, regulations, and processes for allowing importation of medical devices and drugs. Typically medically related shipments have their own unique set of paperwork that must be completed prior to entry into a country.In the USA the FDA has very specific requirements for importing medical devices.
“FDA verifies and enforces applicable medical device requirements at the time a medical device is imported or offered for import into the United States.” - FDA.gov
These requirements include, but are not limited to:
- Establishment registration
- Medical Device Listing
- Quality System
- Premarket Notification [510(k)], unless exempt, or Premarket Approval
- Medical Device Reporting.
This is particularly important if you are a first time importer. The FDA has special requirements for first time importers of medical equipment. Initial importers must report and comply with the below:
- 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.
It is also important to note that Customs and Border Protection extends the definition of an initial importer as any importer that handles the marketing, final delivery, or sale of the imported medical equipment.
“An initial importer is defined in Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g) as 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.” - FDA.gov
Below an example of some additional required information for Manufactures and Importers of Medical Equipment:
It is important to consider the regulatory aspect of shipping medical supplies. These requirements take time and often time are overlooked as part of the transit time. Oftentimes importers and exporters will only look at the time in the land, air, or sea, but it is not uncommon that customs clearance and examination is the longest part of a cargo’s journey. The Vital Worldwide team works with trusted brokers that are familiar with clearing medical shipments to ensure your shipments are handled efficiently and timely.
CURRENT TRENDS (AS OF THE WRITING OF THIS ARTICLE 4/27/2020):
The recent challenges presented by COVID-19 has brought an increased demand for shipping medical supplies. Due to import and export restrictions on general goods placed by many countries(including the US), shipping medical equipment has become a priority. However, this has also restricted the amount of space available on vessels and planes. Care consideration must be given to restricted flight and ocean schedules. We usually advise considering at least one additional week of time to a typical transit in times where space and schedules are in high demand. Restricted space will also increase the cost of shipments. Be sure to factor this into your budget.
Are you an importer or exporter that has shifted focus to medical related cargo? Are you a first time importer or exporter of medical supplies? Whether you are new to the medical industry or well experienced a trusted logistics partner will ensure your cargo moves as efficiently and safely as possible. Our team is familiar with the requirements and specific details in shipping medical cargo. Our experience will ensure your cargo will move with confidence and assurity! We look forward to hearing from you!
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