Singapore Medical Device Regulations

Agency
All medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA)
Medical Device Definition
A medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of (a) diagnosis, prevention, monitoring, treatment or alleviation of any disease; (b) diagnosis, monitoring, treatment, alleviation or or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of physiological process; (d) supporting or sustaining life; (e) control of conception; (f) disinfection of medical devices; (G) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.
Classification of Medical Device
International ClassificationExamplesRisk Level
Class A (Non-sterile)Nonsterile glovesVery Low
Class A (Sterile)Surgical retractors / tongue depressorsLow
Class BHypodermic Needles / suction equipmentLow-Moderate
Class CLung ventilator / bone fixation plateModerate-High
Class DHeart valves / implantable defibrillatorHigh
Premarket Approval Process
Class A (Non-sterile)Class A (Sterile)Class BClass CClass D
Must conform to Essential Principles for Safety and Performance for Medical Devices (EPSP)Appoint Singapore Registrant to submit registration application.
Devices approved in Australia, Canada, the EU, Japan or the USA qualify for an abridged, expedited, or immediate (Class B only) submission process.
Prepare and submit application dossier using ASEAN CSDT format. Provide proof of compliance with QMS. Submit application via theMedical Device Information and Communication System (MEDICS)
Appoint and register importer
HSA will verify classificationHSA will verify classification and conduct an in depth evaluation of application
Approval will be granted. Registrations do not expire.
Postmarket Surveillance
 Every manufacturer, importer, supplier, and registrant of a medical device must maintain a detailed record of every received complaint and submit it to the HSA for inspection.

Source: WHO, HSA

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