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Watercooler conversations February 16, 2024

An executive summary of the regulatory requirements for in-vitro diagnostic medical devices, wellness and fitness products, and aesthetic products in North America, EU, and Asia including India:

An executive summary of the regulatory requirements for in-vitro diagnostic medical devices, wellness and fitness products, and aesthetic products in North America, EU, and Asia including India:

In-vitro Diagnostic Medical Devices

Wellness and Fitness Products

Cosmetic Products

In both the EU and the US, the distinction between aesthetic and cosmetic devices is primarily based on their intended use and the effects they have on the body.

European Union (EU) Under the EU Medical Devices Regulation 2017/745 (MDR), many types of cosmetic and aesthetic products are covered1The EU MDR lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices2A key element for a product to qualify as a medical device in the EU is that it must have a clinical benefit2Although the term “aesthetic” is not included in the medical device (MD) definition, most aesthetic devices are regulated as MDs by the regional authorities based on the devices’ technical specifications and intended use3.

United States (US) In the US, the Food and Drug Administration (FDA) regulates aesthetic (cosmetic) devices depending on their intended use and whether they impact the structure or function of the body4The FDA provides specific regulations related to cosmetics from Title 21 of the Code of Federal Regulations (21 CFR)5For example, a microneedling device for aesthetic use is defined as a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use6This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics6.

In both regions, the classification of a product as a cosmetic or a medical device can significantly impact its regulatory requirements.

Please note that these are general overviews and the specific requirements can vary based on the product and its intended use. It’s always recommended to consult with a regulatory expert or the relevant regulatory bodies for the most accurate information.

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