This e-Service allows a Registrant to report any significant changes regarding a registered higher-risk medical device currently listed on the Singapore Medical Device Register (SMDR).
Supporting documents must be submitted online along with this application, after which:
- The device's listing in the SMDR will be updated; and/or
- An additional device listing will be made in the SMDR.
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Note:
Please submit an amendment application for:
- Minor changes to a registered higher risk medical device without any supporting documents; or
- Significant changes to a registered low risk medical device.
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Need help? View the application guide.
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