NAIROBI PROTOCOL FOR MEDICAL DEVICES
Practical Guide for EU Exporters
Many European manufacturers and exporters of medical devices are not aware that some of their products may qualify for duty-free entry into the United States under an international treaty known as the Nairobi Protocol. This mechanism has been part of U.S. law for many years, yet it remains significantly underused by exporters. Understanding how it works can help companies reduce landed costs and improve their competitiveness in the U.S. market.
This guide explains what the Nairobi Protocol is, how the United States implements it, and what exporters should review before claiming duty-free treatment.
What We’ll Cover in This Blog
What Is the Nairobi Protocol?
The Nairobi Protocol is a treaty adopted under UNESCO. It supplements the earlier Florence Agreement and expands duty-free treatment to include certain articles that are specially designed or adapted for the use or benefit of persons who are blind or have other physical or mental disabilities.
The United States implements the Protocol through specific provisions in the Harmonized Tariff Schedule of the United States (HTSUS) (Proclamation 5978). These provisions appear in Chapter 98 and provide a free rate of duty for qualifying articles.
How the United States Applies the Protocol
The key provisions are HTSUS subheadings 9817.00.92, 9817.00.94, and 9817.00.96. These headings allow duty-free treatment for articles that meet two main criteria:
- The article must be specially designed or adapted for the use or benefit of persons with physical or mental disabilities.
- The disability must be chronic or permanent, not temporary or short-term.
U.S. Customs and Border Protection (CBP) determines eligibility when goods enter the country. CBP also publishes rulings (CBP Customs Bulletin) that exporters can consult to understand how the rules are applied to specific products.
Which Products Can Qualify
Not all medical devices qualify automatically. A product must meet the legal requirements and must have features that clearly distinguish it from general-use medical or consumer products.
Examples of products that have qualified in past CBP rulings include:
- Certain implantable medical devices
- Hearing aids
- Devices supporting mobility
- Articles designed specifically for chronic or permanent disabilities
- Accessories that are uniquely adapted to qualifying devices
In each case, CBP examined whether the product was truly designed or adapted for people with disabilities and whether the disability was permanent or chronic.
What Typically Does Not Qualify for the Nairobi Protocol
CBP rulings and U.S. court decisions consistently show that some products are unlikely to qualify under the Protocol. These include:
- General-use medical devices
- Devices used for temporary or acute medical conditions
- Products with only minor or cosmetic modifications
- Standard therapeutic or diagnostic equipment
- Accessories or components that are not uniquely adapted for disabled users
If the product could reasonably be used by the general population without modification, CBP is unlikely to consider it eligible.
Key Questions for Exporters
EU manufacturers and exporters should assess their products using the following questions:
Is the device intended for a permanent or chronic disability?
Is the design noticeably different from standard devices?
Does the device have features that clearly serve a disabled user?
Is it marketed, regulated or documented as a device for disabled users?
If it is an accessory, is it essential and uniquely adapted to the qualifying device?
If the answer to several of these questions is yes, the product may be a candidate for duty-free entry under the Nairobi Protocol.
Preparing Documentation for the Nairobi Protocol
CBP often requires evidence that the article is specially designed or adapted. Exporters should prepare the following:
- Technical descriptions explaining design features
- User manuals or instructions describing the intended use
- Marketing materials identifying the target users
- Clinical or functional information, if relevant
- Regulatory documentation supporting the device’s purpose
Clear documentation helps reduce the risk of delay or denial at the border.
Binding Rulings for Certainty
If a product is difficult to classify or if an exporter wants certainty before shipping, CBP offers binding rulings. These rulings determine how a product will be classified and whether it qualifies for duty-free treatment.
Binding rulings:
- Are free to request
- Provide legal certainty
- Can be obtained before exporting
- Are published as reference and help exporters understand precedent
For companies exporting a wide range of medical devices, obtaining rulings for key product lines is often a practical approach.
Regulatory Considerations for the Nairobi Protocol
Duty-free status does not change U.S. regulatory requirements. All medical devices imported into the United States must comply with rules enforced by the U.S. Food and Drug Administration (FDA guidance).
This includes:
- Establishment registration
- Device listing
- Premarket clearance or approval where required
- Correct labelling
- Quality system compliance
CBP frequently coordinates with the FDA at the border, so exporters should ensure all regulatory obligations are met before shipping.
At Customs Complete, we assist exporters with duty-free claims under the Nairobi Protocol. We review product classifications, prepare supporting documentation, and coordinate with U.S. customs authorities, helping companies minimize the risk of delays or issues at the border.
Contact us using the form below.
