【EXPERT Q&A】When exporting Class I medical devices, should they be declared for non-medical or medical use?

February 15, 2024  Source: drugdu 67

Drugdu.com expert's response:

 

The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases.

 

However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors:

Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such as beauty or personal care)?

Regulations of the Target Market: Different countries or regions may have different classifications for medical devices. Understanding and complying with the specific regulations and classification standards of the target market before exporting is crucial.

Ultimately, the correct classification will affect the market access, regulatory requirements, and customs clearance process of the product. It is advised to consult with professionals in the field or regulatory authorities before exporting to ensure accurate and proper declaration.

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By editor
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