Foshan United Medical Technologies Ltd (UMT) has gained a UKCA certification — the UK’s version of the CE mark — for its Alginate, Chitosan, Silver Alginate wound dressings and Wound Probe.
On Nov 18th 2022, UMT passed the assessment by its Notified Body BSI on the conformity to the UKCA (United Kingdom Conformity Assessment) requirements for UMT’s Alginate, Chitosan, Silver Alginate wound dressings and the Wound Probe.
The UKCA mark is the United Kingdom (UK) product conformity marking that will be mandatory for a majority of goods including medical devices being placed on the market in Great Britain (England, Wales and Scotland) beginning 01 January 2025. The UKCA mark will be the replacement marking for goods which previously required the CE mark.
Dr Xiaodong Wang, the CEO of UMT comments,
It is a great achievement of UMT to have obtained the UKCA certification before the deadline set by MHRA after Brexit. This is a sign of the strength of UMT R&D and regulatory teams who completed all technical files and required documents within the time frame of BSI.
The UKCA certificate has allowed UMT to continue to distribute the above advanced wound dressings in UK after 2024. It has also given UMT the opportunity to gain experience in the preparation of technical files to meet the requirements of similar regulations such as the MDR.