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What should you know about import declarations? Precautions for the import of medical products

06 Jan 2023

By Nick Lung      Photo:Ketut Subiyanto 

Since the changes in consumption patterns and the impact of the epidemic, the public or companies purchase products from e-commerce platforms based on their own needs or cost assessments. Most people think that products that can be purchased anywhere in physical stores, if purchased from abroad can be imported directly. But you may not know that the products you buy may involve medical products listed and controlled by the Ministry of Health and Welfare. Importers must obtain an import license agreement before importing.

 

What is the definition of a medical product? What else do we need to pay attention to?

Medical products refer to products related to instruments, utensils, and reagents. If their product uses and essential functions or meet the human body, and its purpose is to diagnose, treat, alleviate or prevent human diseases, all are classified as medical products. Commonly imported medical equipment since the epidemic, such as blood oxygen machines, smart watches with heart rate measurement, body fat machines, etc.

 

According to the Ministry of Health and Welfare Food and Drug Administration's announcement of import regulations, products for medical use must obtain an import approval letter from the Ministry of Health and Welfare before importing the goods. Ordinary people can also apply for self-use imports. If the importer cannot determine whether the product belongs to For medical equipment, you can apply for medical equipment attribute management inquiry to the Food and Drug Administration of the Ministry of Health and Welfare to avoid penalties for accidentally violating the Pharmaceutical Affairs Law (a fine of NT$30,000 to NT$150,000)

 

Commonly imported medical products

Blood oxygen machine/blood pressure machine

Electrotherapy massager

Smart watches with heart rate measurement: APPLE WATCH/Xiaomi bracelet, etc.

Heating pad

Body fat machine

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