Exporting Veterinary Medical Equipment to the US: Compliance Requirements Explained!

In recent years, with the rapid growth of the pet health industry, “veterinary medical devices” such as pet therapy devices, monitors and physiotherapy lamps have begun to enter international markets. But to enter the U.S. market successfully, these products need more than innovative technology – they must also meet a number of compliance requirements.

Today we systematically explain which regulations and certifications apply when exporting a pet red-light therapy device (such as a 650 nm laser healing device) to the US.

1. FDA: veterinary devices are regulated differently from human devices

Many companies’ first reaction is: “Since it’s a medical device, it needs FDA registration.” In fact, the US FDA regulates veterinary devices differently from devices for human use:

Therefore:

Pet medical devices usually do not require FDA registration; but if medical efficacy such as “curing disease” or “preventing infection” is claimed, the FDA may treat the product as an unapproved animal drug and take enforcement action.

• Label it “For Veterinary Use Only”;

• Use conservative marketing language such as “promotes recovery” or “supports healing” and avoid “cures” or “treats”;

• If it contains drug ingredients or implant materials, consult the FDA Center for Veterinary Medicine (CVM) as well.

2. Laser products: must comply with CDRH laser safety regulations

Pet laser therapy devices are laser-emitting products. Even if they are not regulated as medical devices, they are still subject to the FDA CDRH (Center for Devices and Radiological Health) laser product performance standards (21 CFR 1040.10 & 1040.11).

Required:

• Laser class label (Class 1, 2, 3R, 3B or 4);

• Laser warning label;

• Safety warnings in the user manual;

• Laser Product Report submitted to the CDRH.

Commonly applicable standards:

• IEC 60825-1 (international laser safety standard)

• ANSI Z136.1 (US laser safety standard)

Recommendation: before export, obtain a Laser Safety Report from an accredited laboratory and register with the FDA

3. FCC: electromagnetic compatibility (EMC) testing

Any product containing electronic circuits, displays, batteries or USB charging ports falls under FCC Part 15B – Unintentional Radiators.

• Test items include:

• Radiated emission

• Conducted emission

Goal: to ensure the product does not interfere with other electronic devices.

Labelling requirement: This device complies with Part 15 of the FCC Rules…

Test standard: ANSI C63.4

4. OSHA/NRTL: electrical safety (for use in veterinary clinics)

If the product will be used in workplaces such as veterinary clinics and pet hospitals, it is regulated by OSHA (Occupational Safety and Health Administration). OSHA requires electrical equipment used in the workplace to be certified by an NRTL (Nationally Recognized Testing Laboratory).

Common certification marks: UL, ETL, TÜV, CSA.

Common standards:

• UL 61010-1 (safety of laboratory equipment)

• UL 60335-1 (household and similar electrical appliances)

NRTL certification is recommended for commercial products.

5. California Proposition 65 (CP65): chemical warning requirements

California’s Prop 65 requires warning labels on any product containing carcinogens or reproductive toxicants.

Common risks in electronic products include:

• Phthalates in plastic housings

• Lead in cables or solder joints

Common label example:

⚠️ WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer or reproductive harm.

We recommend RoHS/REACH or Prop 65 chemical testing to confirm material safety.

6. Other supplementary compliance requirements

7. Summary: a compliance roadmap for exporting to the US