Import and Supply Controls

With effect from 1 November 2007:

Mandatory duties and obligations that all dealers of medical devices must fulfill, are:

1. Duty to maintain records of import and supply
2. Duty to maintain records of complaints
3. Reporting of defects and adverse effects to HSA
4. Notification to HSA concerning field safety correction actions, e.g. recall
5. Prohibition against false or misleading advertisement.

With effect from 10th August 2010:

1) Only licenced dealers can manufacture, import or wholesale medical devices (regardless of the risk classification of the medical devices). Click here268 KB for more information regarding the licences

2) The import and supply of medical devices that are licensable under the Radiation Protection Act (Cap. 262) by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA), shall be exempted from the importer's and wholesaler's licensing requirements under the Health Products Act. However, product registration for such medical devices are mandatory with effect from 1 August 2011. To import and supply, the devices 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.

With effect from 1 January 2012:

All medical devices regardless of its risk classification (unless exempted from product registration), to 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. 

For an understanding of the product registration and licensing of dealers process and requirements, you can download the following Quick Guide379 KB.

Please refer to our Target Processing Timelines for more information on product registration registration timelines.

HSA Press Release193 KB

Published: 1 Nov 2007

Regulatory Updates