March 7, 2014, and came into effect on June 1, 2014, to the public. This amendment implements the spirit of the CPC Central Committee and the State Council on establishing the strictest food and drug regulatory system covering the whole process, accelerating the transformation of government functions
and deepening the reform of the administrative approval system, further standardizing the development, production, operation and use of medical devices, strengthening the supervision and management of medical devices, and helping to ensure the safety and effectiveness of medical devices and safeguarding the public's health
. This revision has a significant impact on the development, production, operation and use of medical devices, which is briefly analyzed below for reference.
I. Improve the classification and management system, and appropriately reduce the prior authorization.
The current regulations of the classification and management system is not perfect, some measures to reflect the differences in the classification is not sufficient, for some high-risk products are not enough to regulate, for some low-risk products should be put on the regulation is not completely free.
This revision clarifies the principles of classification, emphasizes dynamic adjustment, and improves the scientific nature of classification. Classification management of medical devices in accordance with the degree of risk, according to the risk from low to high medical devices will be divided into one, two, three, and according to the medical
device production, operation and use of the product classification catalog in a timely and dynamic adjustment, and requires the development of adjustments to the directory to fully listen to the views of all parties, with reference to the international practice of classification of medical devices. At the same time, improve the classification
class regulatory measures, follow the principle of leniency and strictness, focusing on the supervision of high-risk products.
In terms of medical device product management, the current regulations implement registration management for all medical device products. This revision will be the first class of medical device products by the municipal people's government food and drug administration registration to prepare
case, the second class of medical device products are still by the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration registration, the third class of medical device products are still registered by the State Food and Drug Administration.
In the production of medical devices, the production of Class I medical devices from the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for the record to the municipal people's government of the region for the record of the Food and Drug Administration, engaged in the production of Class II, Class III medical devices, is still by the location of the provinces, autonomous regions and municipalities directly under the Central People's Government of the Food and Drug Administration for permission.
In the medical device business, the abolition of the first class of medical devices for the record, neither the need for licensing, nor the implementation of the record. Engaged in the second class of medical devices by the provinces, autonomous regions,
municipalities directly under the Central People's Government drug supervision and management department license to the municipal people's government food and drug supervision and management department of the region for the record, will be engaged in the third class of medical devices by the provinces, autonomous regions,
municipalities directly under the Central People's Government drug supervision and management department license to the municipal people's government food and drug supervision and management department of the region for the license. Food and Drug Administration of the people's government to the municipal level license.
The revision did not add new approval license, the current regulations provide for 16 administrative licenses minus 7 licenses, including: (1) domestic and imported Class I medical device product registration for the record; (2) the first
The second and third class of non-substantial changes in the registration of medical devices change to the record; (3) to engage in the operation of the second class of medical devices for the record; (4) to engage in the operation of the permit ; (4) cancel the approval of clinical trials of Class II medical devices; (5) cancel the approval of medical
Therapeutic institutions to develop medical devices; (6) cancel the mandatory safety certification of Class III medical devices; (7) reduce the scope of approval of clinical trials of Class III medical devices.
Second, change the regulatory model of medical devices, the provisions of the "first product registration, after the production license.
In the current "production license, after product registration" mode, the manufacturer of medical devices to obtain a production license, but also should obtain product registration before the production and operation of medical devices. In the enterprise to apply for a production license,
required to have with the production of medical devices and the production of appropriate personnel, space, equipment and quality inspection capabilities and other conditions, but due to the production of products at this time the enterprise has not yet been registered after the review, it is difficult to define the production conditions with the production of products
products adaptable. Production enterprises in the production license to complete the process of product registration, resulting in the idle enterprise personnel, space and equipment, increasing the burden on enterprises, is not conducive to industrial development. At the same time, some research institutes are unable to obtain production licenses because
they are unable to obtain production licenses, which limits their innovative research on medical devices.
This revision clarifies the regulatory model of "product registration first, production license later" for medical devices, and stipulates that manufacturers can apply for a medical device production license if they have a medical device product registration certificate. This change in the regulatory model reduces the pressure on early capital investment, further releases the demand for innovation in the industry, and encourages the emergence of innovative enterprises.
Third, to increase the responsibility of the production and management enterprises and the use of units.
The existing regulations on the production and operation of enterprises in the requirements of too much principle, the responsibility is not specific enough. This revision increases and refines the production and operation of enterprises and the use of units of responsibility. Specifically include:
One is to increase the production and operation of enterprises in product quality control responsibility. Requirements for the production of medical devices, production and management of enterprises to establish and improve the product design and development, procurement of raw materials, production process control and other aspects of the quality management system, and to ensure that the system operates effectively, and regularly to the regulatory authorities to submit self-inspection reports.
The second is the establishment of the operation and use of the purchase inspection and sales record system. Requirements for medical equipment business enterprises and the use of units to check the supplier's qualifications and product qualification documents and records; Class II medical device wholesalers and Class III medical device business enterprises to establish sales records.
Third, it is clear that the use of units of medical equipment safety management obligations. Requirements for the use of units to strengthen the training of staff to ensure that in accordance with product specifications, technical specifications and other requirements for the use of medical devices; to set up with the use of medical equipment varieties, the number of storage places appropriate, in accordance with the provisions of the maintenance of large-scale medical equipment and other work.
Four, strengthen the daily supervision, standardize regulatory behavior.
The current regulations lead to the supervision of medical devices exist in the approval of the light supervision phenomenon, as well as regulatory inefficiency, insufficient means of supervision and other issues, the revision of the supervision of medical devices to supplement and standardize. Specifically include:
One is to improve the management system, enrich the regulatory means. This revision adds a medical device adverse event monitoring system, the re-evaluation of registered medical devices, medical device recall system and other management systems.
The second is to strengthen the daily supervision responsibilities. Provides that the regulatory authorities should continue to meet the statutory requirements for the production and operation conditions of enterprises, whether the quality management system to maintain effective operation and other matters to focus on inspection; in production, on sale, in use of medical devices for sampling and quality announcements; have a poor credit record of the unit to increase the frequency of supervision and inspection.
Third is to extend the validity of the registration certificate, standardize the expiration of registration, sampling and other regulatory actions. The revision of the medical device registration certificate is valid from four years to five years, at the same time the expiration of the registration certificate for re-registration into the continuation of the registration
Registration. Clearly stipulated that in addition to three kinds of legal circumstances are not renewed registration, in principle, are to be granted to continue registration. Sampling shall not charge any fees, commissioned the inspection should pay the relevant costs.
V. Improve the legal responsibility.
The current regulations provide for legal responsibility is too general, part of the illegal behavior of the crackdown on the lack of effective basis. On the one hand, this amendment comprehensively refined the penalties, corresponding to the obligations set out in each chapter, according to the severity of violations of the law
Articles and sub-items of the establishment of legal responsibility. On the other hand, adjusted the range of penalties, increased the types of penalties, and increased penalties for serious violations. For example, the unauthorized production and operation of medical devices, the provisions of the
maximum 20 times the amount of the value of the fine, 5 years do not accept the responsibility of the relevant person and the enterprise to apply for a permit for medical devices; clinical trials of medical devices or testing organizations issued false reports, all the withdrawal of the agency's qualifications
quality, 10 years do not accept the application for accreditation and other penalties.