OFweek Medical Network News The State Food and Drug Administration has recently issued a consultation on the “Measures for the Administration of Medical Device Clinical Trial Conditions and Filing (Consultation Draft)â€. The full text reads as follows:
Letter concerning the solicitation of the "Measures for the Administration of Conditions and Filing of Medical Device Clinical Trial Organizations (Draft for Comment)"
Food and Drug Administration Control Letter [2017] No. 42
Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, relevant units:
In accordance with the "Decision of the State Council 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), the medical device clinical testing institution was changed from the qualification certification to the record management. In order to do a good job in relevant implementation, the Medical Device Registration Department of the State Food and Drug Administration has drafted the "Measures for the Administration and Conditions of Medical Device Clinical Trial Organizations (Draft for Comment)", and is now open for solicitation of opinions. Feedback and suggestions before August 25, 2017.
The food and drug supervision administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall organize the opinions of medical institutions and related enterprises within the jurisdiction, and feedback the written opinions and electronic versions to our company. Comments from other organizations or personnel can be sent by email or fax.
Attachment: Medical Device Clinical Trial Institutional Conditions and Record Management Measures (Draft for Comment)
Department of Food and Drug Administration, Equipment Registration Division
August 4, 2017
Medical Device Clinical Trial Institutional Conditions and Record Management Measures (Draft for Comment)
Chapter I General
Article 1 In order to strengthen and standardize the management of medical device clinical trial institutions, these Measures are formulated in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices.
Article 2 The medical device clinical trial institution referred to in these Measures refers to the medical device clinical testing institution submits information such as the organization profile, professional technical level, organizational management ability, and ethical review ability to the food and drug supervision according to the procedures, conditions and requirements. The process of archiving and preparing for management.
Article 3 These Procedures apply to the filing and management of institutions that conduct clinical trials of medical devices within the territory of the People's Republic of China.
Chapter II Recording Conditions
Article 4 The medical device clinical trial institution shall have the following conditions for carrying out the corresponding professional and technical level, organizational management ability, and ethical review capability of the medical device clinical trial:
(1) Having the qualification to practice medical institutions;
(2) Having the qualifications of Class A and above;
(3) Those who undertake the clinical trials of the third type of medical devices that require clinical trial approval shall be a tertiary medical institution;
(4) having a medical device clinical trial management department, equipped with appropriate management personnel, office conditions, and having organizational management and quality control capabilities for clinical trials of medical devices;
(5) having an ethics committee that meets the requirements for quality management practices for clinical trials of medical devices;
(6) having a clinical trial management system and standard operating procedures for medical devices;
(7) having a medical examination subject suitable for medical equipment related to the record-keeping profession and a person capable of undertaking clinical trials of the medical device;
(8) The main investigator of clinical trials of medical devices shall have senior professional titles and participate in more than three clinical trials of medical devices. The professional registration shall be consistent with the medical practice licenses of medical institutions;
(9) The relevant medical business has been carried out to meet the requirements of the test population required for clinical trials of medical devices;
(10) Having emergency mechanisms and handling capabilities for preventing and handling emergencies and serious adverse events in clinical trials of medical devices;
(11) Other conditions stipulated by the State Food and Drug Administration and the National Health and Family Planning Commission.
Article 5 Non-medical institutions such as blood centers and central blood stations that undertake clinical trials of in vitro diagnostic reagents, and disease prevention and control institutions at or above the municipal level shall have at least the following conditions:
(1) having the qualification certificate issued by the corresponding competent department of the business;
(2) The administrative department with clinical trials of in vitro diagnostic reagents, equipped with corresponding personnel and office conditions, and with organizational management and quality control capabilities for clinical trials of in vitro diagnostic reagents;
(3) Being able to carry out ethical review work;
(4) having a clinical trial management system and standard operating procedures for in vitro diagnostic reagents;
(5) having a medical examination subject suitable for the professional-related in vitro diagnostic reagents and a person capable of undertaking clinical trials;
(6) The main investigator of the clinical trial shall have a senior professional title, and the professional filing shall be consistent with the business scope of the institution;
(7) It has carried out relevant business and can meet the requirements of the test population required for clinical trials of in vitro diagnostic reagents;
(8) Having emergency mechanisms and handling capabilities for preventing and handling emergencies and serious adverse events in clinical trials of medical devices;
(9) Other conditions stipulated by the State Food and Drug Administration and the National Health and Family Planning Commission.
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