The State Food and Drug Administration released the draft of technical guidelines for clinical evaluation of medical devices, which has attracted extensive attention and opened up a new way for new products to be listed in China. In June 2015, the guidelines came into effect.
 
Clinical evaluation or clinical trial
 
At present, the new medical device products listed in China have formed a relatively clear path: the first type of device is put on record, and most of the three types of devices require clinical trials, especially the products in the catalogue of category III medical devices subject to clinical trial approval. For class II devices and some class III devices, clinical evaluation or clinical trials are two options.
 
Most companies want to choose clinical evaluation rather than clinical trial. Cost is one of the important reasons. Clinical trials cost a lot and the results are unknown. It is a high-risk investment. A clinical evaluation report (CER) is not cheap. At present, most of the quotations of cro companies are around 200000-300000 yuan, but they are still lower than the investment in clinical trials. Time consuming is another important reason. Considering the time of preparation and start-up, it is usually a good result that a project can be completed in 2-3 years. The clinical evaluation report can be completed in about 3-4 months, which can advance the launch time of new products by at least 1-2 years. Considering that the medical device products are updated quickly and the life cycle is short, the shortened 1-2 years is very valuable for manufacturers.
 
Based on the above reasons, many companies place high hopes on clinical evaluation, so that the quotation of clinical evaluation report rises. However, after reading the technical guidelines for clinical evaluation of medical devices and analyzing the current situation of cmde, it is not difficult to find that the guiding principles issued by the drug regulatory department are not intended to open a fast channel for manufacturers to quickly market a large number of new products, but to "improve the clinical evaluation by distinguishing different clinical evaluation situations and setting corresponding requirements reasonably" It can reduce the burden of management counterpart
 
It's difficult to go public through cer
 
For the products with low risk, stable manufacturing process, no major changes in product design, and a large amount of safety and effectiveness data have been accumulated in the past, it is a waste of resources and time to require the manufacturer to do another clinical trial to provide data. Cer provides a way to use the existing data to complete the evaluation of product safety and effectiveness. However, for innovative and risky devices, it is difficult to complete the listing through cer.
 
One of the difficulties: it is difficult to find a suitable analogy product. The ideal contrast product is a product which has little difference with the application product and has been listed in China. There are not many products that meet this requirement, especially those with technological innovation. In addition, a hidden condition is that the comparison product is better than the previous generation of its own company. This requirement mainly comes from the comparison of production process. If it is not the products of our company, it is difficult to get the production information and parameters. At present, cmde requires to prove the legal source of data. In Article 6 of the notice of the State Administration of food and Drug Administration on the implementation of the administrative measures for the registration of medical devices and in vitro diagnostic reagents issued on November 4, 2015, it is emphasized that "if a manufacturer carries out clinical evaluation in accordance with Article 6 of the guiding principles for clinical evaluation of medical devices, the manufacturer of the same type of medical device is used For technical and clinical data, the applicant should submit the authorization for the use of the same kind of medical device production process, clinical data and other data, so as to eliminate the possibility of obtaining the other party's company information through non-public channels.
 
Difficulty 2: unable to find enough clinical literature. For completely innovative products, it is very difficult to take the CER Road, because of the lack of previous literature and data, cmde will also carefully consider approving innovative products to be listed through cer for risk consideration. If the imported products belong to category II in foreign countries and are not put on the market for a long time without clinical trials, there will be few literatures. Therefore, considering to meet the requirements of this article, products with a long time to market (relatively large number of clinical literature), no significant improvement in production process (no difference or little difference in comparison), and low risk products are more suitable for cer pathway.
 
The third difficulty: the results of clinical literature are inconsistent, and the evidence strength is not enough. Although a large number of clinical literatures can be found in some products, quantitative analysis is required for CER, which requires the introduction of meta analysis. Although there are a lot of literatures, if the final conclusions of these literatures are not consistent, it is still impossible to obtain sufficient clinical evidence. In a cer training session, someone once asked how many clinical literatures cer needed. The speaker's answer was that, ultimately, it depends on the strength of the evidence. If the persuasiveness of the literature is strong and the conclusion is consistent, maybe a few literatures are enough; on the contrary, the persuasiveness is weak, for example, all of them are case reports with only a few cases, and different literature conclusions are not consistent, and it is likely that there are hundreds of literatures The law provides sufficient evidence for the review.
 
The fourth difficulty: it is difficult to obtain the data of Chinese subset. In the part of clinical data set, there is a requirement for Chinese data subset, which is often an obstacle for imported products. On the one hand, in the European and American trials, there are not many Chinese / Asian races involved