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Switzerland Medical Device Regulations

Agency
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
International Classification Risk Level Examples
Class I Low risk Elastic bandages, hearing aids, and simple walking aids.
Class IIa low to Moderate risk Wheelchairs, blood glucose meters, and handheld ultrasound devices.
Class IIb Moderate to High risk Implantable pacemakers, implantable defibrillators, and intravenous infusion pumps.
Class III High risk Implantable artificial heart valves, cerebral stimulators, and high-risk implantable devices such as spinal cord stimulators.
Approval Process
Classification Approval procedure
Class I
  • The manufacturer must demonstrate that the device conforms to the relevant European medical device regulations and standards.
  • The manufacturer must provide detailed technical documentation to Swissmedic, including a detailed description of the device, its intended use, its design, and its performance.
  • Swissmedic may require the manufacturer to provide clinical data and evidence to demonstrate the safety and performance of the device
  • Swissmedic will evaluate the device, its technical documentation, and any clinical data provided. If Swissmedic is satisfied with the information, it will issue a CE mark, which indicates that the device is authorized to be placed on the market.
Class IIa
Class IIb
Class III
Additional Information
Approval timeline 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)
Fees Notification for placing a medical device on the market :- $317
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