The Medical Device Branch is entrusted with the responsibility of regulating medical device products placed on the Singapore market. Our objective is to safeguard public health and safety by implementing regulatory controls through a programme of pre-market assessment of devices, manufacturing controls and post-market vigilance. Medical Device Branch carries out a range of assessment and monitoring activities to ensure medical devices available in Singapore are of an acceptable standard in accordance to the Health Products Act and Health Products (Medical Devices) Regulations.
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The applicant is reminded that, besides registration of the medical device under the Health Products Act, the supply and use of any medical device in Singapore should also comply with the requirements under other applicable legislations (e.g. Private Hospitals and Medical Clinics Act, Professional Acts*, Radiation Protection Act).
*Professional Acts include Medical Registration Act, Dental Registration Act and others.
Guidance documents and draft guidance for consultation
Fees and Charges
Registration, retention, amendment, Dealer’s Licence and other fees
Target Processing Timelines
Target turn-Around-Time (TAT) for product registration and change notification applications
Carry out transactions with MDB and view medical device information online
Medical Devices Risk Classification Tool
To identify the risk classification of medical devices
Search the Singapore Medical Device Register (SMDR)
Health Product enquiry form
Enquire about medical devices
Grouping enquiry form
Enquire about grouping of medical devices
News updates, safety alerts on medical devices and guidance documents
Medical Devices Advisories
For healthcare professionals, industry and consumers