A breathing trainer has become the first Class I medical device imported from Taiwan to complete regulatory filing in Xiamen, after receiving certification from the Fujian Provincial Medical Products Administration.
This product was filed by GaleMed, a company based in the Xiamen FTZ, acting as the domestic agent. The technical requirements met by this product are consistent with those already on the market in the Chinese mainland.
This marks an important step in the integrated development of the cross-Strait medical device industry between Xiamen and Taiwan.
Marketing medical devices from Taiwan in the Chinese mainland previously involved a complex process. However, a plan was introduced to support Fujian's cross-Strait integration efforts, allowing Class I medical devices from Taiwan to be filed locally, enabling a "submitted and finalized within the province" policy.
With this, Taiwan companies can now complete all procedures in Fujian without traveling to Beijing, greatly cutting processing times. The streamlined process reduces costs and makes access to low-risk medical devices faster and easier.