REGULATORY PRACTICE

Case Work

Representative completed and ongoing projects are presented to explain product background, regulatory challenges, working methods, and stage status. No single case replaces an independent assessment of a specific product.

RFNot Regulated as a Medical Device
Radiofrequency Devices

27 MHz RF Delivery Device Regulatory-status Project

Basic Law supported product reconstruction and classification by analysing the RF mechanism, energy parameters, skin safety and intended purpose.

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MCNot Regulated as a Medical Device
Imported Microcurrent

Imported Microcurrent Wellness Device Regulatory-status Project

The project involved multiple rounds of technical analysis and supplementary testing to align the actual imported product with its China submission dossier.

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LEDNot Regulated as a Medical Device
Light-based Devices

“Milk Light” Light-based Beauty-care Device Regulatory-status Project

Basic Law helped the client organise technical parameters, skin safety and non-medical aesthetic use into a reviewable product dossier.

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Digital Project PortalCompliance Center Submit Assessment