APPLIED LASER, Volume. 44, Issue 10, 221(2024)

Overview and Discussion of the Dose-Effect Relationship and Energy Safety Research Data Requirements of Energy Therapy Equipment

Shen Gao and Chang Fengzhu
Author Affiliations
  • Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100076, China
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    The non-clinical research data in the registration materials of energy therapy products, including dose-effect relationship and energy safety research data, are crucial for evaluating the safety and effectiveness of these products. This paper elucidates the specific requirements for various energy therapy products, such as optics, ultrasound, radiofrequency, and microwave equipment. It defines the concepts of dose-effect relationship and energy safety and proposes detailed requirements for the registration research materials pertaining to these aspects. The aim is to provide assistance and guidance to registration applicants and relevant practitioners in submitting pertinent content materials.

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    Shen Gao, Chang Fengzhu. Overview and Discussion of the Dose-Effect Relationship and Energy Safety Research Data Requirements of Energy Therapy Equipment[J]. APPLIED LASER, 2024, 44(10): 221

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    Paper Information

    Received: Jul. 5, 2024

    Accepted: Mar. 11, 2025

    Published Online: Mar. 11, 2025

    The Author Email:

    DOI:10.14128/j.cnki.al.20244410.221

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