There has been a lot of information out there about import requirements for Personal Protective Equipment (PPE) during the COVID-19 Pandemic. Government guidance has changed rapidly and often as we become more aware of how the virus is transmitted. For example, initially the World Health Organization advised a social distancing of three feet. In turn the US adopted a six feet social distancing advisory. It is now being reported that the Virus can travel as far as 13 feet.
FDA Reporting Requirements
As a result of the shortage of Personal Protective Equipment in the United States, FDA has published guidance documents and relaxed import reporting requirements. Although they have relaxed what information we are required to report within the entry the goods are still required to be certified as compliant with the exporting countries’ regulations.
Providing Testing Certification
When dealing with these imports we are requiring proof that the goods have been quality tested to meet the US standards or at a minimum the exporting countries’ standards for their intended use. This proof can be in the form of a certificate of testing by the exporting government agency. In addition, you must also provide the name and address of the actual manufacturer of the goods.
Import requirements are dependent on the intended use. When determining if a good must be reported to FDA, you must take into consideration how the goods themselves and their packaging are marked as well as where the goods are going to be used. For example, if the goods are going to a construction company, they are regulated by the National Institute for Occupational Safety and Health(NIOSH) and are not marked for medical use, they may be able to enter without an FDA declaration. However, if the goods are marked for hospital use or are destined for a hospital or medical facility, those goods would most likely require reporting to FDA.
Reports Of Faulty PPE
Recently there have been reports of care workers complaining of faulty PPE that were imported into the United States. This has caused FDA to emphasize that the goods still must meet quality standards when being imported into the United States, and it is up to the Importer to ensure the goods are compliant. The last thing we need is faulty equipment that puts our care workers in danger and will ultimately prolong the pandemic.
PPE Export Requirements
The United States has put into place safeguards against the export of PPE to ensure that items that are desperately needed to fight this virus such as respirators, surgical masks and gloves, are offered domestically first. All exports of these items now must be approved for export by the Federal Emergency Management Agency (FEMA). Other countries are following suit, such as China, who is requiring that PPE exporting from China must first be reported and approved for export, which could add a week or more to the exporting process during this pandemic.
When donations are sent on a government to government or nation to nation basis, these goods do not require an entry to come into the country. They do need a manifest and certification that the goods were approved for importation under the International Assistance System (IAS).
When donations from private parties are sent to the US for import, they also can qualify to come in without an entry however, they will need to be going to a US recognized tax exempt charity and accompanied by a letter from the charity on their letterhead that they are willing to accept the donation and that the goods will be donated after import. These goods will still need to be reported via an ACE manifest, however an entry will not be required.
Are You Looking At Importing PPE To The US
Pacific Customs Brokers Inc, your premier trade advisor, can assist you in navigating the requirements for import of PPE into the United States.
Read More: How To Import Medical Supplies Into The US