{"id":16907,"date":"2020-12-16T17:32:42","date_gmt":"2020-12-16T16:32:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16907"},"modified":"2023-01-24T14:59:03","modified_gmt":"2023-01-24T13:59:03","slug":"singapore-udi-system-medical-devices","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/12\/16\/singapore-udi-system-medical-devices\/","title":{"rendered":"SINGAPORE: next introduction UDI system for Medical Devices"},"content":{"rendered":"\n

Last 19 October 2020 the Health Sciences Authority (HSA)<\/strong>, Singapore\u2019s Regulatory Authority, announced that it will be introduced a UDI<\/strong> (Unique Device Identification) system to be used for Medical Devices. UDI implementation will take place gradually.<\/p>\n\n\n\n

\"Singapore
Next introduction UDI system for Medical Devices <\/figcaption><\/figure>\n\n\n\n

HSA will accept the UDI labels of the EU and U.S.A devices<\/strong><\/h2>\n\n\n\n

HSA decided to introduce the UDI system in order to start to comply\ninternationally with the labelling requirements of Medical Devices and IVDs, consistently\nwith other countries such as Europe and the United States, where the\nimplementation of the UDI system is well under way or it is about to be, and\nwith China, Brazil e Saudi Arabia.<\/p>\n\n\n\n

In this regard, HSA will consider valid the UDI codes that Manufacturers have applied on the labels of Medical Devices in Europe and in the United States without any need for modification. In addition, the information of these labels together with other information will be collected and published in the Singapore Medical Device Register (SMDR) <\/strong>database.<\/p>\n\n\n\n

UDI labels will only be required for medium-high risk Medical Devices, while\nthey will not be necessary for low-risk Medical Devices (Class A). <\/p>\n\n\n\n

Implementation of the UDI system will begin in 2022<\/strong><\/h2>\n\n\n\n

The first phase<\/strong> of UDI system implementation will begin in 2022<\/strong> with specific high-risk implantable devices, followed by three successive phases which will take place every two years:<\/p>\n\n\n\n