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The introduction of the newly revised "Supervision and Regulation of Medical Devices"

Date: 2016-04-22
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March 31, China Food and Drug Administration and the State Council Legislative Affairs Office jointly held a press conference to promote its implementation of "Supervision and Regulation of Medical Devices" in Beijing. The newly revised "Supervision and Regulation of Medical Devices" was February 12, 2014 by the State Council executive meeting, issued today, will take effect on June 1. Coke Red State Food and Drug Administration Food and Drug Safety Director, Legislative Affairs Office of the State Council Wang Zhenjiang ESCH Secretary attended the meeting and introduced the revision "Regulations", and put forward specific requirements for implementation of the "Regulations".

Safe and effective direct bearing on people's health and social harmony and stability of medical devices is a major livelihood and public safety issues. From April 1, 2000 implementation of the "Supervision and Regulation of Medical Devices" to regulate medical devices development, production, sale, use, strengthen supervision and management of medical equipment to ensure safe and effective medical devices, and promote industrial development played a positive role. With the growing economic and social development and the medical device industry, the "Regulations" in the implementation of category management, strengthening corporate responsibility, innovation means of supervision, promote social cohabitation, punish violations and other aspects can not fully meet the needs of the developing situation. To do this, start the revision of the "Regulations". After much research, demonstration, modify, which lasted six years, today promulgated the revised "Supervision and Regulation of Medical Devices."

The newly revised "Regulations" eight chapters 80, amendments to the "Regulations" embodies the spirit of the CPC Central Committee and State Council on the establishment of the most stringent regulatory system covering the whole process, deepen the reform of administrative examination and approval system and promote the transformation of government functions. "Regulations" to category management as the basis, based on the level of risk, in improving category management, appropriate to reduce the pre-approval, to increase the responsibility of production enterprises and the use of units to strengthen the daily supervision, improve the legal and other aspects to make a greater responsibility modify.

Clear, classified management of medical devices in accordance with the degree of risk the newly revised "Regulations", press from low to high risk medical devices are divided into one, two, three. The first class of medical equipment to implement the record management product, category II, Class III medical devices implement product registration management; first class medical device manufacturers to implement record management, second class, third class medical device manufacturers and the approval management. Meanwhile, the release of the first class of medical devices business, the implementation of record management of Class II medical devices business, the implementation of license management for the operation of Class III medical devices. The newly revised "Regulations" increase the medical equipment manufacturing enterprises control responsibilities in terms of product quality, the establishment of a sales and purchase check record system operation and use of links, additional management responsibility for the safety of medical devices using the unit. At the same time, strengthen the daily supervision responsibilities of regulatory authorities regulate the continuation of the registration, sampling and other regulatory acts, and through the addition of medical device adverse event monitoring system, registered medical device re-evaluation systems, medical equipment recall system, etc., and improve the management system, enrich the means of supervision. In terms of liability, by refining the punishment, punishment amplitude adjustment, increase the punishment range, enhance operability, and increased penalties for serious offenses. In addition, the newly revised "Regulations" not only did the addition of a new license, and combined with previous administrative licensing cleanup, 16 administrative provisions of the original regulations permit reduced to nine.

  Jiao Hong, director at the press conference stressed that promulgated the newly revised "Regulations", fully reflects the CPC Central Committee and the State Council attach great importance to and strengthen the work of the Food and Drug Administration food and drug safety firm determination, specified for future medical device supervision direction. Food and drug supervision departments at all levels to seriously study and deeply understand the spirit of the newly revised "Regulations", strictly implement the newly revised "Regulations" strengthen the supervision and management of medical devices in accordance with law. One is to strengthen the whole management, the implementation of corporate responsibility. Production enterprises in strict accordance with the law for approval, filing matters to strengthen supervision and inspection, to strengthen the production and operation of enterprises and the use of units of daily supervision, and urge them to strictly implement the main responsibility for the effective implementation of the legal obligations. Second, we need change their functions, strengthen supervision according to law. Under the premise of decentralization, according to the approval, highlighting the high-risk products to establish traceability system and medical device adverse event monitoring and re-evaluation, after the recall and other market surveillance system, strengthening the "Things", "after" regulation. Third, encourage technological innovation, promote industrial development. Actively explore and innovative regulatory mechanisms, improve the relevant management system, the implementation of enterprise decompression relaxed, encouraging the requirements of innovation, stimulate the vitality of market players, and actively promote medical device product innovation and upgrading, promote the healthy development of the medical device industry. Fourth, changing regulatory thinking, promoting social cohabitation. Adapt to the changing situation, out of the traditional mode of thinking, encourage and support the participation of all sectors of society, it becomes a single government body for the multi-subject rule by regulation, to form a good pattern of social cohabitation. Fifth, around the outstanding issues, deepen the special rectification. In implementing the "Regulations" as an important opportunity to focus on products, key enterprises, key clues as a breakthrough, carry out the "rectification of false registration application, illegal production, illegal business, hype, product use and other five undocumented behavior" special consolidation and severely punish all kinds of illegal behavior, effective protection of public safety with firearms.


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