Recently, Premier Li Keqiang of the State Council recently signed Order No. 680 of the State Council and promulgated the "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Decision"), which will be implemented as of the date of promulgation.
The "Decision" consists of 10 articles, mainly stipulates the statutory conditions and implementation departments of large-scale medical equipment configuration licenses, and stipulates that the catalogue of large-scale medical equipment shall be submitted by the State Council and submitted to the State Council for approval.
The "Decision" strengthens the post-licensing supervision and management, and stipulates that the health and medical planning department shall supervise and evaluate the use of large-scale medical equipment; and find out the illegal use and over-inspection and over-treatment related to large-scale medical equipment, and correct it immediately. Processing according to law and adding corresponding legal responsibilities.
In addition, the "Decision" will change the qualification management of medical device clinical testing institutions from licensing to filing, and increase the exemption of medical device operating enterprises and users. The following is the revision of specific regulations:
1. Amend Article 18 to read as follows:
"The clinical trials of medical devices shall be carried out in accordance with the requirements of the quality management regulations for clinical trials of medical devices, and shall be carried out in clinical trial institutions with corresponding conditions, and shall be filed with the food and drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial is filed. The food and drug supervision and administration department that accepts the clinical trial record shall notify the food and drug supervision and administration department and the health and family planning department at the same level as the location of the clinical trial institution.
“The medical device clinical trial institution shall implement the record management. The conditions and record management methods and clinical trial quality management regulations that the medical device clinical test institution shall have shall be formulated and promulgated by the food and drug supervision and administration department of the State Council in conjunction with the State Council's health and family planning department.â€
Original: Article 18 The clinical trials of medical devices shall be carried out in accordance with the requirements of the quality management regulations for clinical trials of medical devices, and shall be conducted in a qualified clinical trial institution, and shall be submitted to the food and drug supervision of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government where the clinical trials are filed. The management department files the record. The food and drug supervision and administration department that accepts the clinical trial record shall notify the food and drug supervision and administration department and the health and family planning department at the same level as the location of the clinical trial institution.
The medical device clinical testing institution qualification qualification conditions and clinical trial quality management regulations shall be formulated and promulgated by the food and drug supervision and administration department of the State Council in conjunction with the State Council's health and family planning department; the medical device clinical testing institution shall be jointly organized by the State Council's food and drug supervision and administration department and the State Council's health and family planning department. Confirmed and announced.
2. Combine the first paragraph and the second paragraph of Article 34 as the first paragraph:
"The medical device users shall have storage places and conditions that are compatible with the variety and quantity of medical devices in use. The medical device users shall strengthen the technical training for the staff and use the medical devices in accordance with the product specifications and technical operation specifications."
Add one, as the second paragraph: “The large-scale medical equipment used by medical device users should meet the large-scale medical equipment configuration plan formulated by the competent department of health and family planning of the State Council, which is compatible with its functional positioning and clinical service needs, and has corresponding technical conditions. Supporting facilities and professional and technical personnel with corresponding qualifications and capabilities, and obtaining approval for large-scale medical equipment configuration approval by the competent department of health and family planning of the people's government at or above the provincial level."
Add one, as the third paragraph: "The large-scale medical equipment configuration management measures shall be formulated by the competent department of health and family planning of the State Council in conjunction with the relevant departments of the State Council. The catalogue of large-scale medical equipment shall be submitted by the competent department of health and family planning of the State Council to the relevant departments of the State Council and shall be implemented after being approved by the State Council. "
Original: Article 34 The medical device use unit shall have storage places and conditions that are compatible with the variety and quantity of medical devices in use.
Medical device users shall strengthen technical training for staff and use medical devices in accordance with product specifications and technical operation specifications.
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