Medical device clinical evaluation refers to the process in which the applicant validates whether the products meet use requirements or scope of application through information such as clinical literature, clinical experience data and clinical trials.
All medical device need Clinical Evaluation, but requirements for clinical evaluation data may be different fueled by varied application scope of medical device leading to various risks throughout the use.
2.Types of Clinical Evaluation
For Products listed in Catalogue of Medical Devices Exempted from Clinical Trials (hereinafter referred to as new Exemption Catalogue), applicant/registrant should submitted two part of clinical evaluation data.
√ One part is contrast data of subject product-related information to the contents described in Exemption Catalogue.
√ The other part is Explanation on comparison of subject product to the medical devices approved for domestic registration in Exemption Catalogue
Though comparison with predicate medical device: Applicant/registrant should compare the subject product with one or m
The ethnic differences should be considered and the data of Chinese or Asian Americans should be included.
Recommendations based on clinical evaluation of blood oxygen: The manufacturer is advised to consider the age of patients. Different ages should be included as widely as possible, covering at least 18 to 45 years old. The problem of skin melanin precipitation should be considered in this clinical study. Subjects with different degrees of melanin precipitation (or dark skin) should be included, involving at least two subjects with melanin precipitation or at least 15% of subjects with melanin precipitation (whichever is larger).
In this case, the original registered product can be selected as the predicate to complete the clinical evaluation. The comparison of the predicate mainly focuses on whether there is difference between the product under application and the original registered product. If there is no difference, the available clinical data includes the pre-market and post-market clinical data of the product, and the clinical experience data containing the post-market adverse events.
The technical review of clinical evaluation of medical devices is carried out based on the clinical evaluation dossiers submitted by the manufacturer. If CER or clinical trial pathway is adopted for the clinical evaluation of the medical devices under review, for example, after the applicant submits the registration application dossiers, the declared products are listed in the officially released catalogue of medical devices exempted from clinical trials, and the applicant can complete the clinical evaluation through the catalogue of medical devices exempted from clinical trials according to its needs when supplementing the dossiers. In this case, considering the significant changes in the clinical evaluation dossiers in the supplementary dossiers compared to the initial submission, the applicant can communicate with the reviewers through communication channels including post supplementary consultation and preliminary review.
Article 5 of the Technical Guiding Principles for Accepting Overseas Clinical Trials of Medical Devices has made it clear that “if relevant requirements for clinical trials are specified in technical review guidelines for specific medical devices, such requirements shall be considered for the overseas clinical trials. When there is inconsistency, sufficient and reasonable evidence and basis shall be provided”. Therefore, if the applicant has submitted clinical trial data conforming to ethical, legal and scientific principles in accordance with this Technical Guiding Principle, and fully considered the differences in technical review requirements, test population and clinical trial conditions, it is not necessary to carry out additional clinical trials in China.
As discussed, this is not clarified in the current technical guidance. We believe, however, the updating frequency may be similar to that of EU CERs. This is something we are hypothesizing. Stay tuned for the upcoming final released guidance. It may contain some interpretations or clarifications on this regard.