The State Food and Drug Administration recently issued the closely related normative documents of the medical device clinical evaluation technology of guiding principle and the domestic class III medical devices registration quality management system verification procedures (Interim), etc. Two and medical technology assessment, for the thorny problem of crack evaluation of medical equipment technology has taken an important step, but also aroused the industry to pay more attention to the medical instrument technology evaluation system.
In order to crack the difficult problem of medical instrument technology evaluation, an important step is taken.
Technical evaluation of medical devices, in order to ensure safe and effective medical devices, the use of standards and product technical requirements and other technical specifications, technical evaluation from the inspection and testing, clinical evaluation, technical evaluation of medical device product quality, it is as one of the most important technical supervision of the content of risk management for medical devices.
Recently, significantly speeding up the strength and speed of national reconstruction of medical equipment and technology evaluation system, which makes the enterprise will obviously feel of medical device safety cage is more and more tightly tied, understand the future medical technology assessment of development trend, will help enterprises to seize the market opportunities.
Medical device technology evaluation in the future will show the four development trends.
"Process of technical evaluation management""
Technical evaluation of medical devices is a technical specification of the relevant national standards, industry standards, technical requirements for products such as landing force process and the management process is very stringent, to haggle over every penny is the proper meaning of the management process. For clinical trials such the main clinical evaluation, the implementation of process management is necessary, the introduction of the criterions for the quality control of clinical trials of medical devices, the implementation of medical devices GCP management is the management process "embodied.
In addition, new laws and regulations system requirements for technology products, from product registration and apply for the registration of begin to submit, to the production, management, use, re evaluation and recall all the links require the enterprise to a consistent, also very good reflects the trend of technology evaluation and management of the process. This is an inevitable requirement for the implementation of the whole life cycle management of medical devices, and it is one of the developing trends of the future technical evaluation.
Two, technical evaluation of the material "fine"
Medical device technical evaluation activity is a meticulous work, it requires the material is also very fine, showing a clear "fine" trend. Self report of medical devices and related products of biological compatibility, biological safety, electrical safety research materials, product risk analysis data, clinical evaluation, registration inspection reports and other technical evaluation of material embodiment of a is not fine work. Material "fine" development trend, and technical evaluation management "process" is closely related to "process" management requirements "fine" material to support.
Three, technical evaluation requirements, "strict"
Technical evaluation of medical devices play product safety effectively assess the verification task, not strict to the results, "strict" is not the most serious, only more stringent! Technology evaluation for "strict" trend is General Secretary Xi recently is the food and drug supervision made "the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability and four of the most stringent instructions in the technical evaluation of medical device requirements implemented and embodied.
Worthy of note is that strict technical evaluation, not only to guarantee the quality of the source, but also listed after the implementation of the quality and technical supervisory measures, to avoid anticlimactic technical evaluation process.
Four, the technical evaluation staff "professional"
The success or failure of the technical evaluation of medical equipment and professional staff is the key factors! Enterprises, inspection mechanism, clinical trial institution, technical review mechanism need specialized personnel to complete increasingly specialized medical technology assessment activities. Highly specialized technical evaluation activities have been a serious challenge to the completion of the relevant tasks!
Due to the subject in a serious shortage of medical devices in China education development, high-quality medical professional and technical personnel will be hard to find a, it will be for a long time in the future. The new normal. In the context of rapid development of industry, the number of professional and technical personnel and the quality of the serious impact of the dual problem, it should be caused by the industry and the relevant departments concerned and attention.