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Regulations of the State Council on overhaul of medical device supervision and Administration

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Time:20170525

Recently, Premier Li Keqiang signed 680th days before the decree of the State Council, announced the "decision of the State Council on Amending the regulations on supervision and administration of medical devices" (hereinafter referred to as the "decision"), from the date of promulgation.

The "decision", a total of 10, the main provisions of the implementation of the statutory licensing conditions, configuration of large medical equipment sector, and the provisions of the directory of large medical equipment by the State Council departments, the State Council for approval before implementation.

"Decision" to strengthen the supervision and management of license, shall be specified by the health administration departments of the state health use of large medical equipment supervision and assessment; illegal use and excessive examination, and large medical equipment excessive treatment results, to immediately correct, in accordance with the law, and set up the corresponding legal responsibility.

In addition, the "decision" of the qualification management institution of clinical trial of medical devices by the license to record, and increase the medical equipment business exemption situations of enterprises, the use of units of the following specific amendments modify regulations:

1, modify the eighteenth to:

"Medical equipment to carry out clinical trials, clinical trials of medical devices shall be in accordance with the norms of quality management requirements in clinical trial institutions have the appropriate conditions, and proposed the relevant province, autonomous regions and municipalities directly under the people's government food and drug supervision and management departments for the record to clinical trials. The food and drug administration department that accepts the clinical trial record shall notify the competent departments of food and Drug Administration and the competent departments of health and family planning at the same level where the clinical testing institution is located.

"Clinical trials of medical record management, clinical trials of medical institutions should have the conditions and record management and clinical trial quality management standards, by the food and drug supervision and Administration Department of the State Council for health departments and the public."

Original: Eighteenth medical equipment to carry out clinical trials, clinical trials of medical devices shall be in accordance with the norms of quality management requirements for clinical trials in the professional organization, and author of the province, autonomous regions and municipalities directly under the people's government food and drug supervision and management departments for the record to clinical trials. The food and drug administration department that accepts the clinical trial record shall notify the competent departments of food and Drug Administration and the competent departments of health and family planning at the same level where the clinical testing institution is located.

The clinical trial institution of medical qualification and quality of clinical trial management practices, by the State Food and drug administration under the State Council and the health planning departments to develop and publish; clinical trials of medical institutions by the food and drug supervision and Administration Department of the State Council health planning departments identified and published.

2, the first thirty-fourth paragraphs of the second merger, as the first paragraph:

The unit for use of medical equipment shall have storage places and conditions suitable for the variety and quantity of medical instruments used. Medical device users shall strengthen technical training for their staff and use medical instruments in accordance with product specifications, technical operation specifications and so on. "

One paragraph is added as the second paragraph: "the use of medical devices unit configuration of large medical equipment, large medical equipment configuration planning should be in line with the state health departments to develop, and its function, adapt to demands of clinical service, professional and technical personnel with technical conditions and corresponding facilities and have the corresponding qualifications, ability, and the people's governments at or above the provincial level health planning departments for approval, obtain configuration permits large medical equipment."

One paragraph is added as the third paragraph: "the configuration of large medical equipment management measures by the State Council Health Department in conjunction with the relevant departments of the State Council formulated by the State Council, the directory of large medical equipment health department in charge of the relevant departments of the State Council, the State Council for approval before implementation. "

Thirty-fourth units for medical equipment shall have storage places and conditions suitable for the variety and quantity of medical instruments used.

Medical device users shall strengthen technical training for their staff and use medical instruments in accordance with product specifications, technical operation specifications and so on.

3, the first fifty-sixth paragraphs of the second merger, as the first paragraph:

The food and drug administration shall strengthen the spot check on the medical instruments produced, operated and used by medical device production enterprises and the employing units. No inspection fees or any other fees shall be collected for spot checks, and the necessary expenses shall be included in the budget of the government at the corresponding level. The food and Drug Administration of the people's governments at or above the provincial level shall publish the quality control of medical devices in a timely manner in accordance with the conclusion of random inspection."

One paragraph is added as the second paragraph: "the health planning departments should be on the use of large medical equipment status monitoring and evaluation; found illegal use and excessive examination, and large medical equipment over treatment and other circumstances, should be corrected immediately, shall be handled according to law. "

Fifty-sixth food and drug supervision and administration departments should strengthen the medical device production enterprises and the use of units of production, operation and use of medical equipment spot checks. No inspection fees or any other fees shall be collected for spot checks, and the necessary expenses shall be included in the budget of the government at the corresponding level.

The food and Drug Administration of the people's governments at or above the provincial level shall publish the quality control of medical devices in a timely manner in accordance with the conclusion of random inspection.

4, sixty-third, an increase, as the third paragraph:

If a large medical device is not used without permission, the people's government at or above the county level shall be responsible for the hygiene