The basic law of the medical device Industry is almost drawn up

  • 2018-08-27
The establishment of the Marketing Authorization Holder System for Medical Devices was first proposed in the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices (hereinafter referred as to the Advice) published by the General Office of the CPC Central Committee and the General Office of the State Council issue in November 2017. Coincidentally, the Marketing Authorization Holder System for Medical Devices was also included in the draft of the Regulations issued by the Ministry of Justice on June 25 this year. All of these indicate that a brand-new system will soon be built and will profoundly influence the development of the industry.

The Marketing Authorization Holder System features its highlighted subject, clear goals, powerful means, scientific pathway and expectable assessment outcome. It takes the Authorization Holder as the subject, highlighting the holder's responsibilities and obligations in the product life cycle; it aims to solve the stubborn problem of product marketing review and approval, promote the industry's innovation and development and enhance the fresh impetus for the development of the industry; by canceling the binding of pre-marketing registration with production, it provides the R&D institutions and researchers with the opportunity of working without burden; it opens the gate for the optimal allocation of social resources and innovation and upgrade of products and technologies by reforming the management methods for subcontracted production of the marketed products. Finally, such a system will be evaluated on the basis of three clear dimensions: whether the industry resources are optimally allocated; whether the R&D investment is significantly increased; and whether the technological level is effectively improved. If the system is outstanding in terms of all of the three dimensions, it is a veritable good system! It can be seen that the success of the marketing authorization holder system depends on its performance in terms of the three dimensions.

Given the intrinsic risks of drugs and medical devices and the different scales of both sectors, the attitudes to the implementation of the Marketing Authorization Holder System in the two versions of the Advice mentioned above differ in the drug sector and medical device sector. In terms of drugs, the Advice requires to "summarize in time the pilot experience of the drug marketing authorization holder system, promote the revision of the drug management law and strive to popularize the system across the country as soon as possible". In respect of medical devices, the Advice requires that “the medical device marketing authorization holder shall bear full legal responsibility for the design and development, clinical trials, manufacturing, sales and distribution and adverse event reports (among others) of medical devices, ensure the submitted research data and clinical trial data are real, complete, and traceable and guarantee that continuous researches will be conducted on the marketed medical devices, adverse events timely reported, risk assessed, improvement measures proposed." The comparison between the two shows that the Marketing Authorization Holder System will be fully implemented in preference to drugs in the medical device industry! This is further proved by the relevant amendments in the draft of the Regulations issued by the Ministry of Justice.