Importing N95 Face Masks From China? Call Sequoia Legal for Legal Guidance.

Importing Respirators From China

Are you considering importing respirators from China to the US? In this blog post, Sequoia Legal provides an overview of the legal consideration and steps required before importing respirators from China to the US. Please note that this post is a summary for discussion purposes only and is not a full analysis of the matters presented and may not be relied upon as legal advice.

Step 1: Setting up an entity
Before importing filtering facepiece respirators (“FFRs”) from China, you should set up a legal entity in the US. Establishing a legal entity to import FFRs will insulate you from personal liability and may also provide tax advantages. For guidance on setting up an entity, please see our Choice of Entity blog post.

Step 2: Paying the registration fee
Once your legal entity is set up, you’ll need to complete an Establishment Registration with the FDA and pay their registration fee (currently $5,236). This process allows the FDA to keep track of who is importing and exporting medical devices, such as FFRs. The FDA requires “initial importers,” “repackagers,” and “re-labelers” to register and pay the registration fee. You must pay the fee and register within 30 days of beginning activity or distributing products. Once you pay the fee, you will receive a Payment Identification Number (PIN) and a Payment Confirmation Number (PCN), which you will then use to register your entity at https://www.access.fda.gov/oaa/.

In this context, an “initial importer” is an entity that imports FFRs and distributes them in the US without changing the product or its packaging. A “repackager” “[p]ackages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).” (See FDA “Who Must Register, List and Pay the Fee,” https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee#reprocessor ) A “re-labeler” changes the product’s label from that of the original manufacturer to its own label for distribution under its own name.

Step 3: Complying with FDA regulations
The next considerations are ensuring that the products you plan to import comply with FDA regulations. Under normal circumstances, imported FFRs must be approved by the National Institutes of Occupational Safety and Health (NIOSH). However, under the current emergency circumstances of the COVID-19 crisis, the FDA has relaxed this requirement to allow the importation of a higher quantity of FFRs to meet the needs of the US healthcare system. The FDA announced this change in a letter published on April 3, 2020. The new regulations allow for the importation of FFRs manufactured in China which meet one of the following criteria:

  1. “It is manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by the FDA;
  2. It has a regulatory authorization under a jurisdiction other than China that can be authenticated and verified by FDA; or
  3. It demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by the FDA.”
    See “FFRs Manufactured in China Letter,” US FDA, April 3, 2020.

Simply meeting one of the foregoing criteria is not sufficient to authorize the importation of FFRs into the US; rather, the FDA must confirm that the FFRs meet one of these criteria and officially approve its importation by adding it to “Appendix A.” To get your FFRs in Appendix A, you must email the FDA at [email protected] with the subject line “FFRs Made in China.” Your email must include certain information based on which criterion your FFRs meet.

For criterion (1), the email must include:

  • The manufacturer name, model number and NIOSH approval numbers for your NIOSH approved respirator(s)
  • The manufacturer name, address, model number, and a copy of the product labeling for the respirator you want to be authorized
  • An estimate of the number of respirators you are planning to import during the public health emergency.”
  • See “FFRs Manufactured in China Letter,” US FDA, April 3, 2020.

For criterion (2), the email must include:

  • The manufacturer name, address, model number, and a copy of the product labeling for the respirator you want to be authorized
  • Marketing authorization document/certificate from another regulatory authority or conformity assessment body acting on their behalf (including the authorization number and the name of the conformity assessment body)
  • Certificate of conformity to the applicable standards
  • An estimate of the number of respirators you are planning to import during the public health emergency.”
  • See “FFRs Manufactured in China Letter,” US FDA, April 3, 2020.
For criterion (3), the email must include:
  • The manufacturer name, address, model number, and a copy of the product labeling for the respirator you want to be authorized
  • Name of the testing body
  • Certificate of conformity to the applicable standards
  • Test report demonstrating applicable performance standards have been met
  • An estimate of the number of respirators you are planning to import during the public health emergency.”
  • See “FFRs Manufactured in China Letter,” US FDA, April 3, 2020.

Additionally, regardless of which criterion you meet, all importers must comply with the following:

  • All descriptive printed material relating to the use of the authorized respirators shall be consistent with applicable CDC recommendations for use during the COVID- 19 outbreak.
  • No descriptive printed material relating to the use of the authorized respirators may represent or suggest that the product is safe or effective for the prevention of COVID-19.
  • Importers of authorized respirators must notify manufacturers of these terms and conditions and ensure the destination of these FFRs receive a letter from the manufacturer, in English, which includes the manufacturer, the model, the intended use, and the manufacturer’s webpage if available.
  • Importers of authorized respirators must maintain any records associated with these requirements until the end of the COVID-19 crisis.
  • See “FFRs Manufactured in China Letter,” US FDA, April 3, 2020

Once you have received confirmation from the FDA that your FFRs are in Appendix A and these criteria are met, you can proceed with importing. As noted above, this post does not cover all the necessary steps and issues involved in importing masks and other medical devices from China or other countries. Please contact Sequoia Legal at [email protected] or 973-919-4547 for more information or if you need legal assistance.

 

This publication does not necessarily deal with every important topic or cover every aspect of the topics with which it deals. It is not designed to provide legal or other advice. www.sequoialegal.com/international-business-law