§ COMPARE REGULATORS

Health Canada vs HSA: Medical Device Regulatory Comparison

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

Health Canada

Health Canada — Therapeutic Products Directorate

Canada

Health Canada regulates medical devices through a four-class risk-based system. Class I devices require an establishment license, while Class II-IV require pre-market review. Canada is an MDSAP partic…

CLASSES

Class I, II, III, IV

PATHWAY

MDEL (Class I), MDL (Class II-IV)

KEY FUNCTIONS
  • ▸Medical Device License (MDL)
  • ▸MDSAP single audit program
  • ▸Incident reporting via MEDDEV
  • ▸Medical Device Establishment License (MDEL)

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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§ OTHER COMPARISONS

FDA vs Health Canada

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FDA vs EMA

Compare FDA 510(k)/PMA with EU MDR CE marking — classification, timelines, costs, QMS requirements, …

FDA vs MHRA

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FDA vs Swissmedic

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