Clinical evaluation of laser therapy devices has new guidelines (No.28-2023) issued by the China Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) in July 2023. The guidelines outline essential principles for conducting clinical evaluations and seeking regulatory approval for laser therapy devices. These guidelines not only provide clarity for applicants undergoing the registration process but also serve as a reference for the technical evaluation process carried out by regulatory authorities.
In the rapidly evolving field of medical devices, regulatory standards and guidelines play a critical role in ensuring the safety and effectiveness of products. For companies involved in the development and registration of laser therapy devices, understanding and adhering to these guidelines is important.
Scope and Application
The guidelines apply to laser therapy devices considered as class III with classification code 09-03-01 in the medical device catalogue and intended for various applications, including hair removal, wrinkle reduction, treatment of pigmented skin disorders, and scar treatment. It’s important to note that these guidelines do not cover picosecond laser therapy devices.
Key Requirements for Clinical Evaluation
- Selection of medical devices of the same species: When conducting clinical evaluations under the same species, it is advisable for applicants to choose laser therapy devices with similar technical characteristics and intended applications. This helps establish a relevant comparison and ensures the reliability of clinical data.
- Comparing scope and clinical use information: Detailed comparisons of the scope and clinical use information between the applicant’s device and comparable devices are crucial. Factors to consider include the intended scope, target demographic, usage methods, treatment areas, contraindications, warnings, and precautions.
- Comparative analysis of technical features: Comparing technical features is vital to demonstrate the similarity and compatibility of the applicant’s device with the comparable devices. This analysis should cover aspects such as device structure, laser wavelength, laser type, treatment mechanisms, laser output characteristics, and software functionalities.
- Demonstrating differences don’t affect safety and effectiveness: The guidelines emphasize that differences between the applicant’s device and comparable devices should not compromise safety and effectiveness. Applicants need to provide evidence that any variations in specifications, such as energy output, pulse duration, or other parameters, do not adversely impact the product’s performance.
- Supporting evidence: The guidelines recommend utilizing a combination of in vitro tissue tests and animal studies to support the safety and effectiveness claims. This includes conducting tests that analyze tissue interactions and potential harm, especially for cases where the applicant’s device exhibits differences in performance parameters.
Clinical data compilation and requirements
According to the clinical data requirements for laser therapy devices of the same type, the guidelines recommend prioritizing devices with a track record of long-term clinical safety and substantial clinical data. This data should include information on patient demographics, product specifications, study design, evaluation criteria, and safety-related outcomes.
Applicants can obtain clinical trial data, clinical literature, and adverse event data from the authorized manufacturers of devices of the same type. Given the extensive applicability and relevant evidence for such laser treatment devices, applicants are advised to present key elements, such as application certificates, in graphical formats. This can be done by attaching the original documents and/or texts as appendices.
Further information
Read the original article on the new guidelines on clinical evaluation of laser therapy devices and its same species.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
