The registration process of medical device product requires clinical evaluation. Products with different risks or classifications require different clinical evaluation data, and the clinical evaluation data submitted during the registration process are also different.
The clinical evaluation of medical devices refers to the process by which the applicant confirms whether the product meets the requirements for use or the scope of application through clinical literature, clinical experience data, clinical trials and other information.
According to Article 9 of the "Medical Device Supervision and Management Regulations", clinical evaluation data shall be submitted for the recording/filing of Class I medical devices and the registration of Class II and Class III medical devices.
Among them, the recording/filing of Class I medical devices is not required for clinical trials. Those who apply for the registration of Class II or Class III medical devices, except for products that are exempt from clinical trials, shall undergo clinical trials (as stipulated in Article 22 of the "Administrative Measures for the Registration of Medical Devices").
Conditions that are exempt from clinical trials:
- Have clear working mechanism, finalized design, and mature production process. The same variety medical devices that already on the market have been in clinical application for many years without record of serious adverse events, and no alteration of the general purpose;
- Have non-clinical evaluation which can prove that the medical device is safe and effective;
- Analysis and evaluation of data obtained from clinical trials or clinical use of the same variety of medical devices can prove that the medical device is safe and effective.
Based on the above clinical exemptions, the NMPA has formulated the catalog of medical devices which are exempt from clinical trials (hereinafter referred to as "clinical exemption catalog"). For products that are not included in the catalog, the corresponding clinical evaluation data can be submitted through analysis and evaluation of data obtained from clinical trials or clinical use of the same variety of medical devices.
In summary, the clinical evaluation paths of the medical device registration process mainly include the followings:
- Clinical evaluation of products included in the catalog of medical devices which are exempt from clinical trials
- Clinical evaluation based on clinical data of the same variety medical device
- Clinical evaluation based on overseas clinical data
- Clinical evaluation by trials on simulated human body and small-sample trials
- Clinical evaluation through clinical trials
The main contents of clinical evaluation materials under different clinical evaluation paths:
Clinical Evaluation Paths
Clinical Evaluation Materials
1. In the “Clinical Exemption Catalog”
- Comparison table between the relevant information of the declared product and the content described in the "Clinical Exemption Catalog"
(including product name, classification, description comparison and description of differences)
- Comparison table between the declared product and the medical device that has been approved for domestic registration in the "Clinical Exemption Catalog"
(including model and specifications, basic principles, intended use, structural composition and other differences and supporting information)
2. Clinical evaluation based on clinical data of the same variety medical device
- The comparison items and conclusion requirements of the declared products and the same varieties of products
(The comparison items of passive medical devices mainly include basic principles, structural composition, production technology, production materials, performance requirements, safety evaluation, applicable standards, applicable scope, application methods, contraindications, precautions and warnings, delivery status, sterilization method, packaging label and product manual, etc., and active medical devices also need to consider the comparison of software components’ core algorithm)
- Clinical evaluation report based on clinical data of the same variety of medical devices
(including product overview, comparison description of the same variety of product, evaluation path, collection and analysis of post-market clinical data, supplementary clinical data, etc.)
- Authorization letter for data use
(data obtained through public literature and reports do not require authorization)
- Other supporting materials
3. Clinical evaluation based on overseas clinical data
- Data of overseas clinical trials
(Clinical trial report including clinical trial protocol, ethical opinions, complete analysis of clinical trial data and conclusions)
- Overseas Post-marketing clinical data analysis report
- Difference description
(Differences in technical review requirements, subjects, and clinical trial conditions,)
- Supplemental clinical validation report
(for the differences)
- Other supporting information
(such as literature or comparative information of the same variety product)
4. Clinical evaluation by trials on simulated human body and small-sample trials
- Comparison and differences between the declared product and the comparison product
- Report of the trials on simulated human body
(including test index, test instruments and simulated human body, test conditions, test data, test data analysis, test conclusions, testing person, etc.)
- Small-sample clinical research report
(product overview, body part that is involved, and evaluation criteria, analysis evaluation, summary report)
- Other supporting materials
5. Clinical evaluation through clinical trials
- Clinical trial materials
(clinical trial summary, clinical trial report, clinical trial data)）
- Review of clinical literature and other supporting materials
- Relevant documents approved by the ethics committee
(ethical approval, ICF, clinical trial protocol)
- Location of the clinical trial and contact information of the ethics committee
- Clinical summary report
(including sub-center summary)
- Statistical analysis report
Click here to find more information on how to reduce or avoid clinical trial requirements: How to Avoid or Reduce the Clinical Trial Requirements.