Special Device Types

Software as a Medical Device (SaMD)

Classified via TR-003/TR-004. Documentation should address software lifecycle (IEC 62304), usability (IEC 62366), cybersecurity, and algorithm validation. See SaMD Overview.

IVD Medical Devices

Follow TR-004 classification. Require performance evaluation (not a clinical evaluation report). Submitted through MDIS alongside general device applications.

Active Implantable Devices

Typically Class IV — most stringent requirements. Consider pre-submission consultation with MDD.

Radiation-Emitting Devices

Subject to MDACS and the Radiation Ordinance (Cap. 303). Manufacturers must satisfy both the MDD and the relevant radiation authority. See Radiation Ordinance.

Devices Incorporating Medicinal Substances

The medicinal component may elevate device classification. Document the role of the medicinal component and whether pharmacological activity is ancillary to the device's intended purpose.

Custom-Made Devices

Devices manufactured for individual patients are exempt from MDACS listing. Manufacturers must maintain documentation demonstrating essential principles compliance.

Single-Use Devices

Must be clearly labelled as single-use. Third-party reprocessing raises additional regulatory considerations.