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Medical Device Licence & Regulation
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Medical Marijuana / Cannabis Licence
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Drug and Medicine Licence
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Regulation of pharmacies, dispensaries, and medical facility licenses
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Healthcare Facilities and Hospitals
Medical Device Licence & Regulation
Medical devices are divided into different categories, which require different assessment procedures. The apparent result of a successful conformity assessment is the so-called CE mark. With this label, medical devices can be placed on the market within the European Union and also in Switzerland.
Swissmedic’s focus in the area of medical devices is thus on efficient market surveillance. This is organized on a cross-border basis, especially since the industry has long been globally oriented. Against this background, networking of the authorities across national borders is essential. Joint or coordinated measures always with a view to health protection are becoming increasingly important.
In addition, the designation and monitoring of the so-called conformity assessment bodies and the drafting of requirements in the form of technical standards also fall within the remit of Swissmedic.
Medical Marijuana / Cannabis Licence
Cannabis is classified as a prohibited narcotic in Switzerland. The prescription for medical purposes of unauthorized cannabis-based medicinal products is permitted under certain circumstances.
A cannabis medicinal product is understood to be a cannabis-based substance with a standardized active ingredient content. It must meet safety and quality criteria under medicinal product law. In Switzerland, a physician may prescribe cannabis-based medicinal products (e.g., so-called “extemporaneous preparations”, i.e., medicinal products manufactured by a pharmacy on a physician’s prescription).
Import and export of cannabis and cannabis preparations with CBD and a combined THC content below 1.0%.
For cannabis and cannabis preparations with a total THC content below 1.0 %, no No-Objection Certificate (NOC) can be issued by Swissmedic for import or export, as these substances or products fall internationally under the provisions of the Single Convention.
With regard to the narcotics legislation, it must be demonstrated prior to importation that the products intended for importation have a total THC content below 1.0 %. The corresponding proof by means of a batch-specific certificate of analysis referring to the concrete delivery and issued by an accredited (ISO/IEC 17025) or a GMP laboratory has to be provided.
Drug and Medicine Licence
All medicinal products for the treatment of both in humans and animals are not permitted to be marketed in Switzerland until they have been granted marketing authorization by Swissmedic.
The pharmaceutical products can only be marketed once their quality, safety and efficiency have been adequately proven and verified. The required pharmaceutical testing is complex and often takes several months.
Once the criteria for a marketing authorization have been met, Swissmedic issues a marketing approval, specifies the method of sale (prescription requirement/dispensing points) and approves the technical and patient information. The granting of a marketing authorization is at the expense of the applicant. It must be renewed after every five year period.
Companies that are engaged in the provision of medicinal products in Switzerland require the appropriate licenses for their activities.
To obtain a license, certain requirements must be met. These vary depending on the type of establishment. As a rule, they include:
Professional requirements (person with overall professional and technical competencies), operational requirements (QMS, premises, etc.).
Medicinal product establishments are obliged to safeguard patient and medicinal product safety as well as the quality of therapeutic products at all times. To this end, clear requirements are formulated in the legal provisions. The quality assurance framework must be evaluated at regular intervals to ensure that it is timely and functional, as well as to determine compliance with the applicable legal regulations. Duties, tasks and responsibilities of the individual employees in handling medicinal products must be stipulated in writing. The person technically responsible for curative product handling is responsible for compliance with these rules and for the intrinsic quality of the medicinal products in question.
Healthcare Facilities and Hospitals
Swissmedic is the national competent authority for the supervision of the maintenance and reprocessing of medical appliances, that are intended for use in hospitals. Third-party intermediary service providers that render maintenance and reprocessing of medical devices for hospitals also fall under the responsibility of Swissmedic.
Under the definition, health care facilities are organizations whose primary function is to administer care or treatment to patients or to foster public health. The term “hospital” encompasses all those health care facilities in which inpatient treatment of diseases or inpatient measures of medical rehabilitation or inpatient medical measures for the purpose of aesthetics are implemented by means of medical and nursing assistance.
According to Art. 4 MepV, the term “maintenance” comprises measures such as servicing, software updates, inspection, repair, preparation for reuse, to preserve or restore the operational state of a product. The “reprocessing” is part of the maintenance and includes cleaning, disinfection, sterilization and related procedures, such as product packaging, conveyance and storage, as well as testing and reinstating the technical and operational safety of a product.
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