Re: Non-Invasive Machines Singapore Registration
You can see the definition of the medical device in Singapore here:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/Overview.html
Medical devices are classified into 4 risk classes, when A is the lowest risk and D is the highest risk. The classification rules are adopted from the guidance developed by the GHTF.
Currently, only contact lens care products, radiation emitting devices and condoms come under
statutory control through certain provisions in the Medicines Act and Radiation Protection Act. Recently
voluntary registration deadline in Singapore was extended from 1 May to 1 Aug.
Current post marketing obligations of the medical device dealers are:
- Report adverse events to HSA within stipulated time frame
- Notify HSA prior to the initiation of a product recall
- Keep records of complaints and product distribution
The false or misleading advertisements and promotions of medical devices will be prohibited. HSA can direct an advertiser to publish a “corrective advertisement” for any false or misleading advertisements.
Starting from 1 Aug 2010 onwards, unlicensed manufacturers, importers and wholesalers cannot deal with medical devices.
Starting from 1 Aug 2010, supply of unregistered Class C and D medical devices, that are not on the Transition List, is prohibited.
From 1 Aug 2011, supply of unregistered and un-exempted Class A medical devices and unregistered class B devices is prohibited.