CLA-2-98:OT:RR:NC:N3:135
Nicholas Mooney
Film Logic Custom Brokers
15100 S Broadway
Gardena, CA 90248
RE: The tariff classification of a prototype medical robotic system from Canada
Dear Mr. Mooney:
In your letter dated August 27, 2025, you requested a tariff classification ruling on behalf of your client,
Insight Medbotics.
You state that Insight Medbotics has developed a prototype medical robotic system for product evaluation.
This prototype is not approved for human use by the FDA and is exclusively for testing technical capabilities
and gathering feedback from physicians and key opinion leaders. These evaluations, conducted in
non-clinical settings like offices or conference rooms in the United States, involve demonstrating the robot's
capabilities on a resin anatomical model through mock procedures. During a mock procedure, the robot's
manipulator is moved to different orientations, and off-the-shelf accessories are inserted into the resin model.
This demonstration allows physicians to experience firsthand how the device might be used. The feedback
collected helps refine the design and development of the system. Additionally, the prototype undergoes
technical evaluations in specialized U.S. labs to test parameters such as electromagnetic interference,
bio-material compatibility, magnetic interference, and MRI image artifacts, as well as human factors
evaluations using the prototype. All testing and evaluations with this prototype are performed on test models,
not on humans.
The Insight Medbotics robotic system consists of several components and accessories needed to: 1)
demonstrate the full capabilities of the system using different accessories - all medical accessories are
labelled “For Demonstration Purposes Only”, 2) Perform repairs, and 3) Protect the system and accessories
during shipment. The components and accessories always accompany the system and are shipped back to the
country of origin (Canada), after the evaluation is completed.
The component list includes:
1 - Insight Medbotics Robotic Platform
1 - Insight Medbotics Control Box
1 - Insight Medbotics Spare Carriage
2 - Spare Stepper Motor
1 - Spare Motor Drive
1 - Digital Multimeter
1 - Precision Driver and Bit Set
1 - Longnose Pliars
1 - Philips Screwdriver
1 - HD26 D-Sub Cable 2.5ft
1 - HD26 D-Sub Cable 5ft
1 - Power Cord NEMA
1 - USB Cable A to B 6.5ft
1 - USB Cable A to B 16.5ft
1 - Phatom Prostate w/Lesion
1 - Medical needles BIM 18/20i
1 - Medical needles KIM 16/14T
1 - Medical needles BAM 18/20
1 - Apple AirTag
1 - Nanuk 996 Black Case
2 - Nanuk TSA Lock
You inquired about whether the prototype medical robotic system qualifies for duty free treatment as a
prototype under subheading 9817.85.01, Harmonized Tariff Schedule of the United States (HTSUS), which
provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality
control purposes.”
Based on the information presented, we find that the prototype medical robotic system qualifies for duty free
treatment as a prototype under subheading 9817.85.01, provided that all of the conditions delineated in U.S.
Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States, (HTSUS) are
satisfied.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division