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FDA Medical Device Registration
| Item No.: | Medical devices registration |
Supplier Details
Country: Taiwan
City: Taichung City 428017
Address: No. 12-1, Qiancun E. Rd., Daya Dist.
TEL: +886-4-25685848
Fax: +886-4-25685857
Online Showroom:
103 Products
The FDA defines a medical device as:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to the FDA’s laws and regulations before, during, and after it is offered for sale or use in the United States.
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to the FDA’s laws and regulations before, during, and after it is offered for sale or use in the United States.