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Medical Device Clinical Trial Organization Conditions and Filing Management Measures
According to the "General Office of the Central Committee of the ****, the General Office of the State Council issued "on the deepening of the reform of the review and approval system to encourage innovation of drugs and medical devices," the notice" (Office of the word 〔2017〕 No. 42) and "the State Council on the modification of the" medical device Decision on Amending the Regulations on the Supervision and Administration of Medical Devices (Decree No. 680 of the State Council of the People's Republic of China*** and the State Council of China), the medical device clinical trial organization has been changed from qualification recognition to record management. The State Food and Drug Administration, in conjunction with the National Health and Family Planning Commission, has formulated the "Medical Device Clinical Trial Organization Conditions and Filing Management Measures", which is hereby promulgated and shall come into force on January 1, 2018 onwards.
Chapter I General Principles
Article 1 In order to strengthen and standardize the management of medical device clinical trial institutions, according to the provisions of the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these measures.
Article 2 The medical device clinical trial organization referred to in these measures for the record, refers to the medical device clinical trial organization in accordance with the conditions and requirements set out in these measures, the organization's profile, professional and technical level, organizational and management capabilities, ethical review capabilities, and other information submitted to the food and drug supervision and management department for archiving, the process of record.
Article 3 These Measures shall apply to the Chinese people **** and the country to carry out clinical trials of medical devices in the organization of the record management.
Chapter II filing conditions
Article IV of the medical device clinical trial institutions should meet the requirements of the quality management standard for clinical trials of medical devices, clinical trials of medical devices to carry out the appropriate level of professional and technical skills, organizational and management capacity, the ability to ethical review of the following conditions:
(a) with a health care institution Qualification;
(b) with the qualification of Grade 2A or above;
(c) to undertake clinical trials for approval of Class III medical devices should be Grade 3A medical institutions;
(d) with the management of clinical trials of medical devices, equipped with appropriate management personnel, office conditions, and have the organization of clinical trials of medical devices and quality control capabilities;
(d) with the management of clinical trials of medical devices, equipped with appropriate management personnel, office conditions, and have the organization of clinical trials of medical devices and management Quality control capabilities;
(E) ethical committees in line with the requirements of the quality management standard for medical device clinical trials;
(F) has a medical device clinical trial management system and standard operating procedures;
(G) has a clinic with the development of relevant medical device clinical trials compatible with the medical subjects, and should be the same as the license to practice in the health care institutions;
(H) has a medical device clinical trial management system and standard operating procedures;
(I) has a clinical trial of medical devices, and should be the same as the license to practice medical subjects;
(VIII) is a medical device clinical trial management system;
(viii) has the ability to undertake clinical trials of medical devices, medical device clinical trials principal investigator should have a senior title, which carries out innovative medical device products or clinical trials need to be approved for the third class of medical device products clinical trials principal investigator should have participated in more than three medical device or drug clinical trials;
(ix) has carried out the relevant health care business, can meet the requirements of medical device clinical trials;
(ix) has carried out the relevant medical business. To be able to meet the requirements of the test population needed for clinical trials of medical devices;
(j) with the prevention and treatment of emergencies in clinical trials of medical devices and serious adverse events in the emergency response mechanism and disposal capacity;
(k) the State Food and Drug Administration, the National Health and Family Planning Commission of the other conditions specified.
Article V In addition to meet the conditions of Article IV of this approach to medical institutions, other clinical trials of in vitro diagnostic reagents to undertake blood centers and central blood stations, municipal-level disease prevention and control institutions, drug rehabilitation centers and other non-medical institutions to carry out clinical trials of in vitro diagnostic reagents managed by medical devices, which should have the following conditions:
(a) with the corresponding competent authorities Issued by the organization's qualification documents;
(b) with in vitro diagnostic reagents clinical trials management department, equipped with the appropriate personnel, office conditions, and has the in vitro diagnostic reagents clinical trials of the organization, management and quality control capabilities;
(c) able to carry out the ethical review work;
(d) with the in vitro diagnostic reagents clinical trials management system and standard operating procedures;
(d) with the clinical trials management system and standard operating procedures;
(e) with in vitro diagnostic reagents to carry out clinical trials compatible with the diagnostic subjects, and should be consistent with the scope of business of the organization;
(f) with the ability to undertake clinical trials of the personnel, clinical trials should be the principal investigator of a senior title;
(vii) has been carried out in the relevant business to meet the requirements of in vitro diagnostic reagents for clinical trials of the subject population, etc.;
(g) has carried out the relevant business, and to meet the requirements of clinical trials of the Subject population requirements;
(viii) with the prevention and treatment of emergencies in clinical trials of medical devices and serious adverse events in the emergency response mechanism and disposal capacity;
(ix) the State Food and Drug Administration, the National Health and Family Planning Commission, other conditions.
Chapter III Filing Procedures
Article 6 The State Food and Drug Administration to establish a medical device clinical trial organization filing management information system (hereinafter referred to as the filing system), used to carry out the work of medical device clinical trial organization filing management.
Article VII of the medical device clinical trial organizations should be in accordance with the requirements of this approach to the unit whether the conditions and ability to assess the clinical trials of medical devices, and their own record in the filing system.
Article VIII of the medical device clinical trial organization shall, in accordance with the requirements, in the filing system to truthfully fill in the following:
(a) the name of the organization, the nature of the organization, address, contact information.
(b) the level of the organization, the size of the profile, including beds, staffing, floor space, medical equipment and so on.
(C) proposed to carry out clinical trials of medical devices and the specialty of the principal investigator profile.
(d) The person in charge of the management of medical device clinical trials and contact information.
(e) submit a self-examination report containing the following:
1. overview of the management of clinical trials, personnel, management system, standard operating procedures, etc.;
2. overview of the ethical committee or ethical review, including personnel, systems, etc.
3. overview of the establishment and operation of the quality management system of clinical trials of medical devices;
< p> 4. Clinical trial management personnel, researchers, medical device clinical trial related regulations and professional knowledge training;5. Prevention and treatment of emergencies in the clinical trial of medical devices, serious adverse events in the emergency response mechanism and the ability to deal with the situation;
6. Previously carried out in the clinical trial of medical devices;
7. Other information needed to be explained The situation.
Article IX of the medical device clinical trial institutions should be in accordance with the requirements of the filing system, uploading the license license of medical institutions, medical institutions level documents, other institutions qualification documents and information compliance statement and other materials.
Article 10 The medical device clinical trial organization for the record to obtain the record number can undertake clinical trials of medical devices.
The filed medical device clinical trial organization name, address, contact person, contact information and principal investigator and other relevant filing information can be queried in the filing system.
Article XI of the medical device clinical trial organization name, organization level, the organization responsible for personnel, address, ethics committee, medical device clinical trial professional and principal investigator filing information changes, the medical device clinical trial organization should log in the filing system, fill in the online information changes.
Article XII of the medical device clinical trial institutions should be submitted online before January 31 each year to carry out the previous year's medical device clinical trial work summary report.
Article XIII of the medical device clinical trial organization decided not to carry out clinical trials of medical devices, should log in the filing system, cancel the record.
Chapter IV Supervision and Management
Article 14 The food and drug supervision and management departments at the provincial level and above shall regularly notify the administrative region of the medical device clinical trial organization filing information to the same level of the health care administration.
Article 15 Provincial food and drug supervision and management departments, health and family planning administrative departments shall, in accordance with their respective regulatory responsibilities, to strengthen the supervision and management of medical device clinical trial organizations in the administrative region and information notification. For the violations found, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" and other relevant laws and regulations to organize the investigation and handling.
Article 16 The concealment of relevant information or provide false materials for the record of clinical trial institutions, or defects, it is not appropriate to continue to undertake clinical trials of clinical trial institutions, food and drug supervision and management departments at the provincial level or above in accordance with the "Supervision and Management of Medical Devices Regulations" provisions of the treatment. The State Food and Drug Administration to cancel its institutions or related professional filing information, notify the National Health and Family Planning Commission, and announcements.
Article 17 The filing information of the medical device clinical trial organization involves state secrets, commercial secrets or personal privacy, it should be in line with the "Law of the People's Republic of China*** and the State of Conservation of State Secrets" and other relevant laws and regulations.
Chapter V Supplementary Provisions
Article 18 The format of the medical device clinical trial organization record number is: the mechanical clinical organization to prepare +4 digits of the era number +5 sequential number.
Article 19 The food and drug supervision and management departments to implement the clinical trial organization for the record and supervision and management, shall not charge any fees.
Article 20 These measures shall come into force from January 1, 2018 onwards.