Release date: 2015-07-10
Announcement of the State Food and Drug Administration on the Relevant Matters Concerning the Recording of Medical Device Clinical Trials (No. 87 of 2015)
According to the provisions of the Regulations on the Supervision and Administration of Medical Devices, the clinical trials of medical devices shall be filed. The relevant matters for the filing are now announced as follows:
1. To carry out clinical trials of medical devices, the sponsor shall fill out the "Medical Device Clinical Trial Record Form" (Annex 1) after the essay has been approved by the ethical review and signed an agreement or contract with the clinical testing institution, and submitted to the filing form. Relevant materials, in which domestic medical equipment is filed with the provincial food and drug supervision and administration department where the sponsor is located, and the imported medical equipment is filed with the provincial food and drug supervision and administration department where the agent is located.
2. The provincial food and drug supervision and administration department that accepts the record shall complete the "Medical Device Clinical Trial Record Form" and complete the submitted materials, and shall file it on the spot. The record number is arranged as follows: X1 is equipped with XXXX2XXXX3, where X1 is the abbreviation of the location of the filing department, XXXX2 is the year, and XXXX3 is the serial number.
3. The provincial food and drug supervision and administration department that accepts the record shall, within 10 working days, notify the relevant food and drug supervision and administration department and the health and family planning department at the same level of the clinical trial institution with the record information (see Appendix 2 for the format).
4. From the date of publication of the announcement, the clinical trials of medical devices shall be carried out in accordance with the provisions of this announcement.
5. After the sponsor completes the clinical trial record, if there is any change in the start and end date of the test project, the original record management department shall be notified within 10 working days after the change and a record of information change shall be retained.
6. The food and drug supervision and administration department shall strengthen the supervision and inspection of the medical device clinical trial filing work, and investigate and deal with violations of the regulations.
The provincial food and drug supervision and administration department that accepts the record shall submit the filing information to the Medical Device Registration and Management Department of the State Food and Drug Administration (E-mail:) by e-mail 10 days before each month.
Special announcement.
Source: Medical Device Innovation Network
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