From Medi Medical News
Medical devices, like drugs, are commodities related to everyone's life and health, and are important products to save lives, promote human health and improve the quality of life. The supervision and management of medical devices in my country has begun in the 1980 s, but the unified whole-process supervision and legal supervision of medical devices have been continuously developed since the first round of drug supervision and management system reform in 1998. The history is short. Although the regulatory practice in recent years has proved that this regulatory model and system is effective in ensuring the effective use of equipment by the people and promoting the sustainable and healthy development of the medical device industry, there are more and more problems exposed in practice, among which the legal system is not perfect. Is one of them. To this end, starting from this issue, this edition will publish a series of reports on "Exploration of Legal Issues in Device Supervision", combining with the problems exposed in the law enforcement of primary medical device supervision to explain the current lack of medical device supervision laws, and propose to improve my country's medical device supervision laws. Ideas and suggestions, in order to inspire relevant legislative departments and supervisors. At the same time, readers are welcome to contribute and discuss with us the legal issues of medical device supervision in practice.
 
At present, my country's medical device industry is developing rapidly, and it is also in line with international standards. However, the proportion of medical device production and sales is very small, and the use (consumption) market is huge and the demand is strong, which leads to the production, operation and use of medical devices in my country. Diversified, complicated supervision methods. Although since the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") promulgated by the State Council on April 1, 2000, China has basically formed a legal system for all-round supervision of the production, operation and use of medical devices. In order to ensure that medical devices have effectively played an active and important role, the medical device industry has also developed rapidly, but it should be noted that, the process of legalization of medical devices in China is still in its infancy, and the current regulatory legal system is still imperfect.
 
Before the "Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products" was issued in 2007, according to the "Regulations" and its supporting regulations, there was no definition of "fake and inferior" for medical devices, and relevant laws and regulations did not set prohibitions and relevant punishment measures for the operation and use of medical devices that did not meet the standards (except for the relevant provisions in Article 145 of the Criminal Law, but the starting point of sentencing is higher). Once a medical device is registered, even if there are quality problems, its operators and users can only be left alone and cannot be relied on. Because of this, the grass-roots drug regulatory departments often feel that it is difficult to put in place the supervision according to the current laws and regulations, and the detection and investigation rate of some illegal acts is not high.
 
Current Situation of Medical Device Production Management Regulations
 
In order to regulate the production of medical devices in China and ensure the safety and effectiveness of medical devices from the source, since the release of the Regulations in 2000, the former State Drug Administration has successively issued 10 regulations, including the measures for the Administration of Medical Device Registration, the rules for the Classification of Medical Devices, the measures for the Supervision and Administration of Medical Device Manufacturing Enterprises, the measures for the Assessment of the quality system of Medical Device Manufacturing Enterprises, and the measures for the Administration of Medical Device Standards. In 2004, with the promulgation and implementation of the Administrative Licensing Law, in accordance with its requirements, the national food and drug regulatory department revised and issued four departmental regulations, including the Regulations on the Administration of Medical Device Instructions, Labels and Packaging Marks, and the Measures for the Supervision and Administration of Medical Device Production, as well as four operational specifications (procedures), including the Operational Specifications for Registration and Approval of Domestic Class III and Overseas Medical Devices (Trial), subsequently, the "Administrative Measures for Medical Device Standards" were revised, and normative documents such as the "Regulations on Daily Supervision and Management of Medical Device Production" and the "Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events (Trial)" were formulated. The promulgation of the above-mentioned departmental regulations and normative documents shows that the supervision and management of medical devices in China is gradually moving towards the stage of legalization at a faster speed in recent years. However, objectively speaking, the current supervision and management of medical device production in China is still wide, loose and scattered in many aspects, and the procedures are complicated and not concise enough. In addition, the relevant laws and regulations are not perfect, which not only affects the R & D and production of medical device production enterprises, but also is not conducive to enterprise innovation and technological progress. Therefore, the author thinks that it is necessary to revise the relevant laws and regulations as soon as possible according to the actual situation, so as to protect the healthy and orderly development of medical device production in China.
 
Current Situation of Medical Device Circulation Management Regulations
 
At present, in the field of medical device circulation in my country, in addition to the above-mentioned "Regulations", other management regulations include "Measures for the Supervision and Administration of Medical Device Business Enterprises" and "Measures for the Supervision and Administration of Disposable Sterile Medical Devices." In 2004, according to the "Administrative Licensing Law" that has been promulgated and implemented, the State Food and Drug Administration revised the "Measures for the Supervision and Administration of Medical Device Business Enterprises" to the "Measures for the Administration of Medical Device Business License", which provides for the administrative licensing and licensing of medical device business enterprises. However, there is still a lack of corresponding management regulations for medical device products in the circulation process, especially for non-enterprise institutions or natural persons engaged in the management of medical device business activities, which makes the actual supervision a mere formality, resulting in management Vacancy and blind spots. Although the promulgation of the "Special Provisions of the State Council on Strengthening the Supervision and Management of Food and Other Products" in 2007 has made some compensation for this, the author believes that because the penalty setting is not reasonable enough, it is still difficult to operate in practice. Therefore, there is still a long way to go to improve the management regulations in the field of medical device circulation.
 
Current Situation of Medical Device Use Management Regulations
 
In our country, in addition to ordinary home medical devices, medical devices are mostly used in medical institutions. However, my country has not yet issued regulations on the safe use of medical devices. It is only stipulated in Article 26 of the "Regulations" that "medical institutions shall obtain the" Medical Device Manufacturing Enterprise License "from the production enterprise or the" Medical Device Business Enterprise License "" The operating enterprise purchases qualified medical devices; medical institutions shall not use unregistered, unqualified, expired, invalid or eliminated medical devices ". Article 27 stipulates that "medical institutions shall not reuse disposable medical devices; if they have been used, they shall be destroyed in accordance with the relevant provisions of the State and recorded". There are no provisions for medical institutions in terms of procurement, storage, installation and use, maintenance, quality inspection, regular inspection and post-processing. This obviously cannot meet the requirements of the use of medical devices. It not only easily leads to accidents in the use of medical devices, but also brings great confusion to the supervision and management of the regulatory authorities in accordance with the law. Therefore, the use of medical devices also need to develop appropriate regulations as soon as possible to strengthen management.