Import and Supply Controls
With effect from 10th August 2010:
1) Only licenced dealers can manufacture, import or wholesale medical devices. Click here for more information regarding the licences.
2) Class C and D medical devices (but excluding those medical devices currently licensed under the Radiation Protection Act by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA)) that are imported and supplied must meet one of the criteria below:
- Listed on the Singapore Medical Device Register (SMDR);
- Listed on the Transition List; OR
- Authorised via one of the Authorisation Routes.
NOTE: Class C and D medical devices currently licensed under the Radiation Protection Act by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA) shall be exempted from product registration with HSA until 01 August 2011.
With effect from 1 January 2012:
Unless exempted from product registration, all medical devices, including class A and B medical devices, that are imported and supplied must meet one of the criteria below:
- Listed on the Singapore Medical Device Register (SMDR);
- Listed on the Transition List; OR
- Authorised via one of the Authorisation Routes.
Please refer to our Frequently Asked Questions (FAQ) for more information.
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Industry Briefing on the Implementation of Health Products (Medical Devices) Regulation Presentation Slides
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