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Business Taxes Law Guide—Revision 2024
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425.0000 Prescription Medicines—Regulation 1591
Annotation 425.0430
(b) Specific Items Classified
425.0430 Implantable Defibrillator and Related Devices. The microprocessor based programmable implantable defibrillator is a device which is implanted in a patient with a heart dysfunction for up to seven years. The device monitors the patient's heart signals and detects abnormal heart rates. Once detected, the device provides a defibrillation energy to correct the heart rhythm. The implanted defibrillator is connected to the heart via leads which are also implanted with the device. Both the implantable defibrillator and the implantable leads qualify as exempt medicines under Regulation 1591(b)(2).
The implanted defibrillator is inoperable without first being programmed by the doctor. This is done with a receiving and transmitting defibrillator programmer which is not implanted in or on the body.
A high voltage stimulator is an electronic instrument used during the implantation surgery for the defibrillator device to evaluate the proper pacing and defibrillation setting and therapies to be programmed into the device by the programmer. It is not implanted in or on the body.
Both the defibrillator programmer and the high voltage stimulator do not qualify as exempt medicines because they are not implanted in the human body. They are in the nature of medical devices or appliances specifically excluded from the term "medicine" under Regulation 1591. 11/30/89.