Finally from 2022 Singapore will become consistent with European countries, through the implementation of the UDI system, thus significantly simplifying trade.
Already in October 2020, the Health Sciences Authority of Singapore, i.e. the regulatory authority on the import, production, export and supply of medical devices, had announced that such a system would be introduced; all this in order to comply with the European and US system, and to guarantee patients greater safety, traceability and traceability of medical devices and to optimize therapeutic pathways.
In essence, the UDI codes, applied by manufacturers, on the labels of medical devices in Europe and in the USA, will be fully valid in Singapore, without the need to request changes. Subsequently, the information on the relevant labels will be entered and published in a database, called Singapore Medical Device Register.
Initially, we will see the implementation of the UDI system for specific high-risk implantable medical devices, for which manufacturers before the beginning of the year will send all the necessary information to the SMDR and the devices will be labeled.
Once this first phase has been completed, an evaluation of the results obtained will take place and changes will be made if required. This first step is followed by another 3, one every 2 years; that is, in 2024 this system will be applied to class D medical devices, in 2026 to class C medical devices, and in 2028 to class B medical devices.
Clearly this orientation is to be very much welcomed for all manufacturers of Italian and European quality medical devices who will have fewer obstacles to be able to market their products in the rich Asian island-state.
