January 10, 2020
After publishing the guidance of clinical evaluation in the International Medical Device Regulators Forum (IMDRF), the NMPA has quickly released the revised guidance of clinical evaluation for China registration. This guidance is predicted to be implemented by 2021. Please have a look at the additional details provided and catch up with the update of the CER requirements.
The NMPA released the revised draft guidance of CER for medical devices in early January. This guidance consists of three main parts: “Definition”, “Clinical Evaluation” and “Clinical Trial”, complying with the new guidance of clinical evaluation issued by the International Medical Device Regulators Forum (IMDRF). At the moment, NMPA is seeking for public comments on the guidance.
This guidance is applicable to the clinical evaluation of medical device registration. However, it does not apply to IVDs. Following Qualtech’s analysis of the guidance, the new requirements for the “Clinical Evaluation Part” of the draft version are quite different from the current CER guidance. Thus, Qualtech would like to introduce our readers to the “Clinical Evaluation Part” via our generated summary:
Clinical evaluation of medical devices refers to the continuous activities of evaluating and analyzing clinical data with scientific and reasonable methods to confirm the safety, clinical performance, and/or effectiveness of the product under its applicable scope.
The clinical evaluation comprehensively analyzes the pre-market and post-market clinical data (including safety, clinical performance and/or effectiveness data) under the scope of the intended use, collecting data of similar products, and the registered product. It includes three stages:
1. Identifying relevant clinical data;
2. Assessing the relevance, applicability, quality, and clinical significance of each data set;
3. Analyzing each data set to reach conclusions related to product safety, clinical performance and/or efficacy, and product information (label and instructions).
The applicant shall verify that the registered product meets the requirements stated below through clinical evaluation:
1. The product achieves the expected performance;
2. The product does not cause safety issues to the patients or users;
3. The risks associated with the use of the device are acceptable compared to the patients’ gained benefits;
4. Basic principles of safety and performance; and whether post-marketing clinical follow-up studies are needed.
The reference outline of the revised CER is structured as stated below:
- Basic introduction of the product: including, among other things, the product’s name, intended use, raw materials or composition of the product.
- Indications of the product
- Evaluation of the Product Equivalence: The applicant shall evaluate various aspects regarding the concept of safety and performance, such as; among others, the intended use, the main specifications, the working principle, and biocompatibility. The applicant can offer the pre-clinical data to support the safety and efficacy regarding the difference between the similar product and the registered product.
- Summary of the clinical evidence and assessment: The applicant shall refer to the guidance of CER to assess the clinical evidence and summarize it into a clinical evaluation report. It is also acceptable to include overseas clinical trial data in the report under certain conditions.
- Analysis of the data: The applicant shall evaluate the safety and performance of the registered product by analyzing the available clinical evidence. In addition, the collection of adverse events having occurred globally is necessary to be mention in this section.