Drugdu.com expert's response:

The clinical evaluation pathway for medical devices is a crucial process for assessing their safety and effectiveness, determining their suitability for market release and clinical use. Below are the general steps and considerations for determining the clinical evaluation pathway for medical devices:

Ⅰ. General Steps

Clarify Product Characteristics and Scope of Application: Understand the basic principles, structural composition, manufacturing materials, and intended use of the medical device. First, confirm the scope of application of the product to facilitate targeted clinical evaluation.

Assess Clinical Risks and Existing Clinical Data: Analyze potential adverse events or risks associated with the product during use. Evaluate whether sufficient clinical data exist to support the safety and effectiveness of the product.

Select Clinical Evaluation Pathway: Based on product characteristics, clinical risks, and existing clinical data, select the most suitable clinical evaluation pathway.

Ⅱ. Considerations

Inclusion in the "Catalogue of Medical Devices Exempt from Clinical Evaluation": If the medical device falls within this catalogue and meets specific conditions, it may be exempt from clinical trials and directly applied for registration.

Similarity to Existing Products with Valid Registration Certificates: When the product is similar to an already marketed product with a valid registration certificate, its safety and effectiveness can be demonstrated through comparative analysis (e.g., same-kind comparison). This includes comparisons of performance, composition, morphology, etc., to confirm the equivalence between the new product and the known product.

High-Risk or Innovative Medical Devices: High-risk or innovative medical devices, as well as those that cannot fully demonstrate their safety and effectiveness through the above two methods, require clinical trials for verification. Clinical trials may include preliminary human studies, controlled studies, or large-scale multicenter studies, depending on the type and risk level of the medical device.

Ⅲ. Specific Pathways

Exemption from Clinical Trials Pathway: Applicable to products listed in the "Catalogue of Medical Devices Exempt from Clinical Evaluation" and meeting specific conditions.

Same-Kind Comparison Pathway: When the product is similar to an existing product with a valid registration certificate, clinical evaluation reports can be formed by collecting and analyzing clinical literature and/or clinical experience data for same-kind medical devices. If differences exist between the product and the same-kind product, it needs to be verified whether the differences can be proven not to adversely affect the safety and effectiveness of the product through non-clinical study data, clinical literature data, clinical experience data, or clinical trial data conducted in China for the differences. If so, a clinical evaluation report can be formed; if not, clinical trials should be conducted.

Clinical Trials Pathway: Applicable to high-risk, innovative products, or those that cannot demonstrate their safety and effectiveness through the exemption from clinical trials and same-kind comparison pathways. Clinical trials include the preparation stage (e.g., product inspection reports, animal experiments, research on CRO and clinical data, protocol design and writing, etc.), implementation stage (e.g., patient enrollment, clinical monitoring, etc.), and conclusion stage (e.g., quality control, summary, data entry and analysis, etc.).

Ⅳ. Precautions

Follow Relevant Regulations and Guidance Principles: When selecting the clinical evaluation pathway, relevant regulations and guidance principles issued by the National Medical Products Administration (NMPA) of China should be followed.

Ensure Data Authenticity and Accuracy: During clinical evaluation, the collected and analyzed data should be true, accurate, and complete.

Consider Ethical Requirements: The trial protocol must comply with ethical standards, safeguarding the rights and safety of patients.

In summary, determining the clinical evaluation pathway for medical devices requires comprehensive consideration of product characteristics, clinical risks, existing clinical data, and relevant regulations and guidance principles. When selecting a pathway, the authenticity and accuracy of data should be ensured, and ethical requirements should be followed.