2017 (3) TMI 1275 - AT - Customs

Classification of imported goods - Thermacool Thermage Radio Frequency Therapeutic device and its accessories - beauty care equipment or medical device? - classified under CTH 8543.7093 or CTH 9018 9099? - benefit of N/N. 12/2012-Cus - Held that - the goods imported by the appellant are to be used for dermatological and general surgical procedures for electro coagulation and hemostasis; and non invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids - The said equipment is used only by the qualified Doctors - impugned items cause the remodeling and re-generation of collagen (protein connective tissue) in dermal and sub-cutaneous layers of skin. Because of physiological changes or changes in anatomy, skin gets tightened. On a perusal of above uses, it is apparently clear that the device is nothing but a medical device which helps in treatment - it stand clearly marked on the said technical literature that the goods are for use by Registered Medical Practitioner, Hospital or a laboratory only - also, certificate of TUV Rheinland (applicable authority) has certified the goods as medical device - goods are properly classified under Chapter 9018 - appeal dismissed - decided against Revenue.

Issues Involved:
1. Classification of the imported goods.
2. Applicability of exemption notifications.
3. Determination of the nature and use of the imported device.
4. Relevance of previous case laws and international definitions.

Detailed Analysis:

1. Classification of the Imported Goods:
The primary issue is the correct classification of the "Thermage CPT System" under the Customs Tariff. The original adjudicating authority classified the goods under heading 8543.7093 as "professional beauty care equipment," while the appellants claimed classification under heading 9018.9099 as "therapeutic devices."

The Commissioner (Appeals) ruled in favor of the appellants, stating that the goods are essentially Radio Frequency (RF) Systems used for tightening and contouring of the skin and must be used by professionals with technical knowledge like doctors. The explanatory notes to CTH 9018 cover instruments used in professional practice to diagnose, prevent, or treat an illness. The Commissioner (Appeals) concluded that the device is for medical treatment of skin-related conditions and not merely a beauty care device.

2. Applicability of Exemption Notifications:
The appellants claimed the benefit of Customs Notification No. 12/2012, Central Excise Notification No. 12/2012, and Notification No. 21/2012, asserting that the goods were for use in medical science. The Commissioner (Appeals) supported this claim by highlighting that the goods were accepted as "therapeutic devices" and thus should benefit from the said exemptions.

3. Determination of the Nature and Use of the Imported Device:
The device, Thermage CPT, uses RF energy to treat the skin non-invasively, stimulating collagen to remodel and regenerate, thus tightening the skin. The Commissioner (Appeals) noted that the device is used by qualified doctors for various medical purposes, including dermatologic and general surgical procedures, non-invasive treatment of wrinkles, temporary improvement in cellulite appearance, minor muscle pain relief, and local blood circulation improvement.

The Commissioner (Appeals) emphasized that the device's medical use, as supported by FDA certification and technical literature, indicates it is a medical device rather than a beauty care product. The device's operation involves sophisticated technology that requires professional medical knowledge, further supporting its classification under CTH 9018.9099.

4. Relevance of Previous Case Laws and International Definitions:
The Revenue cited previous Tribunal decisions and international definitions to argue that the device should be classified as a beauty care equipment. However, the Commissioner (Appeals) and the Tribunal found these arguments unconvincing. The Tribunal's decision in "New Look Cosmetic Laser Centre vs. CC Mumbai" and CBEC Circular No. B-11/1/2002-TRU were referenced to support the classification of the device as a medical apparatus.

The Tribunal also considered international definitions, such as the EU Council Directive 93/42/EEC, which defines a medical device as any instrument used for human beings to investigate, replace, or modify the anatomy or physiological process. The TUV Rheinland certificate and FDA certification further supported the classification of the Thermage CPT System as a medical device.

Conclusion:
The Tribunal upheld the Commissioner (Appeals)'s decision, classifying the Thermage CPT System under CTH 9018.9099, and dismissed the Revenue's appeal. The device was recognized as a medical apparatus used by qualified doctors for therapeutic purposes, thereby qualifying for the claimed exemption notifications.

(Pronounced in the open court on 24/3/17)

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