Any person who wishes to perform cytogenetic or molecular genetic tests in a medical context requires authorisation from the Federal Office for Public Health (FOPH).
The Federal Council, after consulting the Commission, may:
make additional genetic tests or prenatal risk assessments subject to the authorisation requirement, if these tests or assessments must satisfy the same requirements as cytogenetic or molecular genetic tests with regard to quality assurance and the interpretation of results;
waive the authorisation requirement for cytogenetic or molecular genetic tests that are not subject to special requirements with regard to their performance and the interpretation of the results;
make individual steps in a process that are performed in facilities without authorisation in accordance with paragraph 1 subject to the authorisation requirement.
Authorisation shall be granted if:
the required technical and operational criteria are met, and
a suitable quality management system exists.
The Federal Council shall regulate:
the requirements placed on the laboratory manager and laboratory personnel and on the quality management system, and the operational criteria;
the duties of the holder of the authorisation;
the authorisation procedure;
the supervision, in particular the possibility of unannounced inspections; and
the information exchange between the relevant federal and cantonal bodies with regard to authorisations and supervisory activities.