S.L. 458.59 · Medical Devices And In-Vitro Diagnostic (S.L. 458.59)
S.L. 458.59 Art. 6Obligation for medicaldevice registeredperson.
(1) No person shall act as a medical device registered person responsible for any medical device locally unless they have registered as such with the competent authority.
(2) Any person who applies for registration as a medical device registered person shall satisfy any eligibility requirements as may be established by the competent authority.
(3) Any person registered as a medical device registered person with the competent authority shall be issued a registration document.