§ COMPARE REGULATORS

Swissmedic vs HSA: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs HSA (Singapore).

Swissmedic

Swiss Agency for Therapeutic Products

Switzerland

Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device…

CLASSES

Class I, IIa, IIb, III

PATHWAY

EU CE recognition / Swiss conformity assessment

KEY FUNCTIONS
  • ▸MedDO compliance oversight
  • ▸Recognition of EU CE certificates
  • ▸Swiss market surveillance
  • ▸MDSAP participation

HSA

Health Sciences Authority (Singapore)

Singapore

Singapore's HSA regulates medical devices using a four-class risk-based system (A, B, C, D). HSA accepts conformity assessment from recognized bodies and is a founding member of IMDRF. Singapore serve…

CLASSES

Class A, B, C, D

PATHWAY

HSA registration

KEY FUNCTIONS
  • ▸Device registration (Class B-D)
  • ▸Class A dealer license
  • ▸GN-13 guidance compliance
  • ▸Adverse event reporting
  • ▸IMDRF participation

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