Editor's Note: The newly revised Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council) (hereinafter referred to as the “Regulationsâ€) ushered in the implementation of the “Year of the Year†on June 1. In the past year, the implementation of the newly revised "Regulations" and a series of supporting regulations, as well as the implementation of the national "five rectification" special rectification actions for medical devices , further promoted the development of China's medical device industry from chaos to governance and market order. And the development of medical device supervision has played a huge role. On this occasion, the author carefully sorted out a series of changes brought about by the newly revised Regulations to the medical device supervision work, and raised some confusions in the implementation of the regulations for everyone to explore.
Aspect 1: Classification Management Improves Regulatory Effectiveness
According to the newly revised Regulations, the state implements classified management of medical devices according to the degree of risk, and divides medical devices into one, two, and three categories according to the risk from low to high, and implements strictness on medical devices of different risk levels. Other management measures. For example, the first type of medical devices (with low risk and regular management to ensure their safe and effective medical devices) are subject to product filing management, and there is no need to apply for the Medical Device Registration Certificate. It is stipulated that the operation of the second type of medical equipment does not need to apply for the "Medical Device Business License", and only need to be filed with the municipal food and drug supervision department of the local district. However, implanted medical devices that stipulate high risks shall not be commissioned; the operating enterprises of the third category of medical device retail business shall establish a sales system; and, increase the penalties for the unauthorized operation of the third type of medical devices, the highest A fine of 20 times the amount of the goods can be paid; at the same time, the medical device user is required to save the original materials purchased when purchasing and using the third type of medical devices to ensure the traceability of the information.
Comments: This kind of "strict and strict, different and different" regulatory measures, effectively implement the medical device classification management into the supervision and management process, and concentrate the supervision focus on high-risk medical devices to a reasonable extent. Configure regulatory resources, improve regulatory effectiveness, and ensure the safety and effectiveness of medical devices.
Aspect 2: Refine the penalty and enrich the basis
The newly revised "Regulations" for the forgery, alteration, sale, lease, lending, "medical device business license", production, business instructions, labels do not comply with the newly revised "Regulations", not in accordance with medical device specifications and labeling requirements Transportation and storage of medical devices, transfer of medical devices that have expired, failed, eliminated or failed inspections, medical device operating enterprises, and users have not established and implemented medical device purchase inspection and record system in accordance with the newly revised Regulations. All have established penalties. At the same time, it emphasizes the combination of execution and punishment, and requires that the public security organs should give public security management penalties in violation of the "Public Security Administration Punishment Law" in the relevant illegal cases. It is worth mentioning that the newly revised "Regulations" set penalties for the production, operation and use of medical devices that do not meet the mandatory standards and do not meet the technical requirements for registered or filed products; The Regulations only impose penalties for the production of non-compliant medical devices. For medical devices that do not meet the standards, only the special provisions of the State Council on strengthening the safety supervision and management of foods and other products can be applied. The behavior of medical devices is almost impossible to rely on.
Comments: According to the development of the medical device industry, the newly revised "Regulations" set penalties for new threats to the safety of medical devices in the market, and changed the embarrassing situation that some illegal acts could not be relied upon. Effectively stopping and correcting illegal activities provides a strong legal guarantee. In particular, the use of medical devices that do not meet the standards is officially included in the scope of administrative management, so that penalties for such acts are law-abiding, and the starting point of punishment is high, which can effectively curb illegal activities. It should be noted that in the past year, the number of food and drug regulatory authorities at all levels in the country has greatly improved the number and quality of medical device investigations, and has changed from simple behavioral punishment to quality penalty. These are all gratifying changes brought about by the newly revised "Regulations". It has brought China's medical device supervision work to a new level, and the level of product quality and safety has been greatly improved.
Aspect 3: Eliminate blind spots and repeat fines
Article 76 of the newly revised "Regulations" states that "a medical device use unit refers to an institution that uses medical devices to provide medical services such as medical services to others, including medical institutions that have obtained medical institution licenses, and obtains family planning technology. The family planning technical service institution of the service organization license, and the blood station, the apheresis plasma station, the rehabilitation aid device adaptation mechanism, etc., which do not need to obtain the medical institution license.
The newly revised "Regulations" are aimed at the production and operation of Class II and Class III medical devices that have not obtained the "Medical Device Registration Certificate", and engage in the production of Class II and Class III medical devices without permission. In the case of three types of medical device business activities, a fine of 20 times the maximum measurable value was established.
Comments: Unlike the "Regulations" before the revision, the newly revised "Regulations" will include some units that use medical devices but do not need to apply for medical institutions to apply for supervision, fill the regulatory vacancies and cover the blind spots of supervision. . In addition, the newly revised "Regulations" have increased the intensity of punishment, enhanced the deterrent effect of the law, greatly increased the cost of illegal activities, and effectively curbed the occurrence of illegal acts.
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