Smedtrum Has Obtained Taiwan QMS

Smedtrum Has Obtained Taiwan QMS

On May 1, 2021, Taiwan's new medical device regulations has hit the road by having a specific law established particularly for planning the relevant management system according to the product characteristics of medical devices.

Also, the medical equipment quality management system has changed from the original GMP (Good Manufacturing Practice for Medical Devices) to QMS (Medical Device Quality Management System). In addition, based on the old GMP, QMS refers to the revised guidelines of ISO 13485:2016, which is in line with the international system to ensure that medical device manufacturers in Taiwan are also following international standards.

Smedtrum has taken the lead in introducing QMS as early as 2021, passed it successfully in March this year, and became a qualified medical equipment manufacturer in Taiwan.

With Taiwan’s latest medical device quality management system aligned to international standards, Smedtrum is ready to bring our high-quality products to the world.


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