Swissmedic, the Swiss Agency for Therapeutic Devices regulates medical devices in Switzerland.
Medical Device Definition
Medical Devices are instruments, apparatus, devices, software, implants, reagents , materials or other items:
a) which according to the manufacturer are intended for humans;
b) whose intended main effect in or on the human body is neither achieved by pharmacological or immunological means nor metabolically, but whose mode of action can be supported by such means; and
c) which alone or in combination fulfill one or more of the following specific medical purposes:
1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
2. Diagnosing, monitoring, treating, alleviating or compensating for injuries or disabilities,
3. Examination, replacement or modification of the anatomy or of any physiological or pathological process or condition,
4. Obtaining information through the in vitro examination of samples from the human body – including from organ, blood and tissue donations.
The following are also considered medical devices:
a) contraceptive or contraceptive products;
b) Products specifically intended for the cleaning, disinfection or sterilization of the products
Medical Device Classification System
||Elastic bandages, hearing aids, and simple walking aids.
||low to Moderate risk
||Wheelchairs, blood glucose meters, and handheld ultrasound devices.
||Moderate to High risk
||Implantable pacemakers, implantable defibrillators, and intravenous infusion pumps.
||Implantable artificial heart valves, cerebral stimulators, and high-risk implantable devices such as spinal cord stimulators.
||Class III devices:- Approx. 6 to 9 months, All other devices:-Approx. 1 to 6 months.
|License validity period
|| 5 years (as long CE Mark is valid)
||Notification for placing a medical device on the market :- $317