Announcement of registration and declaration of medical devices (including in-body diagnostic reagents).

In order to do a good job in the administrative acceptance of medical devices (including in-body diagnostic reagents), after discussion with the Medical Device Registration Management Department, medical device technical review center, the relevant issues related to registration applications are clearly as follows: 1, on the requirements related to clinical evaluation materials
(i) in-body diagnostic reagents registration
"Food and medicine" Article 7, paragraph 3, of the Notice of the General Administration of Supervision on the Implementation of matters relating to <> and<> (Food and Drug Administration No. 144, hereinafter referred to as "Notice") stipulates: "After the implementation of the Measures, in-body diagnostic reagents shall be clinically tested after they have passed the registration test." If the clinical trial agreement has been signed before the implementation of the Measures, the clinical trial report of the clinical trial conducted before the registration test may be submitted as the registration declaration and the clinical trial agreement shall be submitted at the same time". Where at least one clinical trial agreement has been signed before October 1, 2014, the original requirements for the submission of ethics, sealing, registration test time, etc. of clinical trial data may be implemented.
"written opinion of the Ethics Committee agreeing to the conduct of clinical trials" in clinical trial data should be issued by all clinical trial institutions. Article 7, paragraph 3, of the Notice, states in the provisions of clinical trial institutions: "For products for special purposes of use, clinical trials of in vitro diagnostic reagents may be conducted in institutions such as CDCs, specialized hospitals or inspection and quarantine centers, drug treatment centers, etc. that meet the requirements." For the above-mentioned institutions without clinical trial institutions ethics committee, to carry out in-body diagnostic reagents clinical trials, the clinical trial institutions should issue a non-ethics committee statement and the clinical trial ethics review opinions.
(2) Medical device registration
1. For products included in the Category II Medical Devices Directory for Exempt from Clinical Trials and the Category III Medical Devices Catalog for Exempt from Clinical Trials (hereinafter referred to as the Directory), the requirements for submitting clinical evaluation information upon registration application:
(1) to submit the information about the declared products and the matching information to the contents of the Directory;
(2) The statement of the ratio between the declared products and the medical devices of the same variety that have been listed in the Directory shall include the "Comparing Table of Medical Devices of the same varieties listed in the Declaration Products and The Catalog" (see annex) and the corresponding supporting information.
the above information submitted by the Government shall prove that the declared product is equivalent to the product described in the Catalogue.
2. For products that are clinically evaluated by comparison with medical devices of the same variety, the applicant shall submit clinical evaluation data in accordance with the relevant provisions of the Measures for the Administration of Medical Device Registration.
3. For products conducting clinical trials, applicants should submit clinical trial agreements, ethics committee approvals, clinical trial programs, and clinical trial reports.II. General requirements for the declaration of information
all documents in the declaration materials (including inspection reports) may be submitted and marked with a copy of the original when they are submitted again after they have been submitted and accepted.3. With regard to the issue of renewal of registration
If the registrar is unable to submit the original registered product standard original when the registration is renewed, he shall submit a copy of the original registered product standard, a description of the reasons for the failure to submit the original and a declaration that the copy submitted is consistent with the original.4th, on the registration change related issues
(1) when applying for a change in licensing matters, the registration inspection report for the product technical requirements change part shall contain pre-evaluation opinions.
(2) A change in the production address of imported medical devices (including in-body diagnostic reagents) (including a change in the text of the production address) is a change in licensing matters.
(3) Changes in registration and licensing matters may be applied for separately, or they may be combined. Where a merger application is made, the applicant shall fill out the application form separately and indicate the change of merger registration/licensing matters in "Other Issues to Be Explained".article 5, paragraph 2, of the "Notice
on the application for the renewal of registration and registration changes provides that: "Before April 1, 2015, the application for the merger of the renewal of registration and registration changes may be submitted in accordance with the requirements of the renewal of registration and registration changes." The specific requirements will be specified as follows:
(1) If the application for the merger of registration and registration changes is made, fill in the Application Form for the Registration of Medical Devices/In-body Diagnostic Reagents and the
Application form for the Registration of Medical Devices/In-body Diagnostic Reagents, respectively;
(iii) If the application for the combination of registration, change of registration matters and change of licensing matters is completed, the application form for the renewal of registration of medical devices/in-body diagnostic reagents, the application form for the registration of medical devices/in-body diagnostic reagents and the application form for the change of registration of
medical devices/in-body diagnostic reagents shall be completed respectively; Consistent and indicate "Merge registration changes or/or license changes" in "Other issues to be addressed".
(5) The registration, registration and licensing changes shall be submitted in accordance with the requirements of the renewal registration and registration changes respectively. If the same information (including supporting documents and technical information) is used in different registration applications for the same product, only one original of the information may be provided with the declaration of any one of the registration applications, and the source of the original declaration information shall be indicated in other applications.
this announcement.
The Administrative Matters Reception Service and Complaint Reporting Center of the State Administration of Food and Drug Administration
November 25, 2014 (Pharmaceutical Network)