| Regulatory Authority | Health Authority |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | They don't have a regulation for medical device, but they use Italian or European legislation |
| IVD Classification | A,B,C,D |
| Registration Process | All the procedures or regulatory guides are the same as use in Italy or in Europe |
| Requirement of Authorized Representative | Yes |
| Certificate of Free Sale |
Issues free sale certificates to San Marino manufacturers of medical devices operating in compliance with EU Regulation 2017/745. |
| Adverse Event Reporting Form | Download |
| Additional Information | The Health Authority acts as the Competent Authority in the field of Medical Devices for the Republic of San Marino. Given the regulatory gap present in San Marino in the specific sector of medical devices, the Health Authority issues this circular to protect the health of citizens and consumers. The introduced System is inspired by the principles defined worldwide for the regulation of Medical Devices, and adopts the regulatory framework defined by the European Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). |