Register of Medical Device Manufacturer's Licence Holders
After 10 Aug 2010, any company that manufactures finished medical devices is required to obtain a manufacturer's licence from HSA. Certification to ISO 13485 is one of the pre-requisites for the manufacturer's licence.
To view the Register of Medical Device Manufacturer's Licence Holders, please access this link.
 |
Import and Supply Controls
With effect from 1 November 2007:
Mandatory duties and obligations that all dealers of medical devices must fulfill, are:
- Duty to maintain records of import and supply
- Duty to maintain records of complaints
- Reporting of defects and adverse effects to HSA
- Notification to HSA concerning field safety correction actions, e.g. recall
- Prohibition against false or misleading advertisement.
1) Only licenced dealers can manufacture, import or wholesale medical devices (regardless of the risk classification of the medical devices). Click here 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.
Please refer to our Frequently Asked Questions (FAQ) for more information.
For an understanding of the product registration and licensing of dealers process and requirements, you can download the following Quick Guide.
Please refer to our Target Processing Timelines for more information on product registration registration timelines.
|
Industry Briefing on the Implementation of Health Products (Medical Devices) Regulation Presentation Slides
|
|
|
|
|
|
|
|
