State Food and Drug Administration Request for Comments on the Revision of Application Documents for Continued Registration of Instruments

On May 21st, May 21st, the State Drug Administration issued a notice to publicly solicit opinions on amendments to medical device registration, application requirements for clinical trial approval, and explanations.

medical instruments The amendments to the requirements and instructions for the continuation of the registration application are as follows: Attachment 5 of the Announcement Concerning the Announcement of the Requirements for the Filing of Medical Device Registration Documents and the Format of the Approved Certification Documents and the Announcement of the Announcement of the Requirements for the Application for the Registration of In-vitro Diagnostic Reagents and the Format of the Approved Certification Documents. Attachment 4, 'V. Product Analysis Report during the validity period of the registration certificate' and 'Related contents of '(i) ~ (6)', amended to 'V. If the original medical device registration certificate stated in the registration requirements of the medical device requires continued work, it shall provide Relevant summary report, with accompanying information'.

The amendments to the requirements and instructions for the application of medical device clinical trial approvals are as follows: “Announcement on the Announcement of the Requirements for Publication of Medical Device Registration Documents and the Format of Approval Certification Documents” in Annex 7, “II. Proof of Documentation”, and (b) Overseas Applications A person should submit: 1. The overseas applicant's place of registration or production address in the country (region) where the medical device authority issued the product to allow the listing of the product sales documents and legal qualifications certification documents; 2. Overseas applicants designated in China proxy The person's power of attorney, agent's undertaking and a copy of the business license or a copy of the organization's registration certificate ', is amended to' (b) The foreign applicant shall submit: The power of attorney of the foreign applicant's designated agent in China. Copies of the Letter of Commitment and the copy of the business license or a copy of the organization registration certificate '. Will the ethical committee agree with the written opinion of the clinical trial: The ethical committee of all clinical trial institutions shall submit the written opinion of the clinical trial to be approved', and amend to Nine, the ethics committee agrees with the written opinion of the clinical trial: In conducting multi-center clinical trials, the lead ethic committee should be submitted to agree with the written opinion of the clinical trial; In the non-multi-center clinical trials, should submit all clinical trial institutions The Ethics Committee agrees with the written opinion of the clinical trial'.