Importation of Medical Devices Shall Be Made in Accordance with the Import Regulation Coded as "504" Regardless of Their CCC Codes

Taipei Customs(台北關)

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Importation of Medical Devices Shall Be Made in Accordance with the Import Regulation Coded as "504" Regardless of Their CCC Codes

Taichung Customs(TCC)expresses that, recently, some importers importing medical devices for human use have repeatedly failed to declare and list the number of the pre-marketing license issued by FDA(Food and Drug Administration, MOHW)in the import declaration. The importers misread that tariff CCC codes without the import regulation coded as "504" are exempted from the above regulation, leading to controversy between customs and importers, and also affecting customs clearance seriously.

TCC took "nursing bed" for example, despite its HS Code is classified as Subheading 9402.90, it is still within the scope of medical devices and need to be handled according to Article 40 of Pharmaceutical Affairs Act (PAL). For the import of medical devices, an application all shall filed with FDA for registration and market approval. No import is to be allowed until a medical device permit license is approved and issued. Besides, only the owners of a medical device permit license or their authorized persons may apply for import of medical devices. Alternatively, importers could make project application of medical devices on the basis of regulations governing management of samples and gifts. After receiving approval from FDA, import of medical devices would be permitted.

In order to facilitate import customs clearance, TCC reiterates no import of medical devices are to be allowed without prior approval from FDA no matter which tariff CCC codes should be. In addition, if there were any questions whether import goods belong to medical devices, TCC advises importers to consult with FDA to avoid any violation of PAL.

  • Publish Date:2018-04-13
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