Further elaborate the preparation and technical review of innovative medical device declaration materials as stipulated in the “Special Approval Process for Innovative Medical Devices†(Food and Drug Administration [2014] No. 13). On December 15, the State Food and Drug Administration issued the “Innovationâ€. Guidelines for the preparation of medical device special approval application materials.
Guide to the preparation of special medical device approval documents
In order to standardize the application for special approval for innovative medical devices, improve the quality of application materials, and promote the innovation and development of medical devices, combined with the current practical experience of special approval for innovative medical devices, according to the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650), Medical Devices Registration Management Measures (Order No. 4 of the State Food and Drug Administration), “Administrative Measures for the Registration of In Vitro Diagnostic Reagents†(Order No. 5 of the State Food and Drug Administration), “Special Approval Procedure for Innovative Medical Devices (Trial)†( The Food and Drug Administration (2014) No. 13) requires the development of this guide.
This guide regulates the preparation and writing of application materials for applying for innovative medical devices. It aims to make the applicants clear the key points that should be paid attention to during the reporting process, with a view to resolving some common problems encountered during the reporting process.
First, the content of the application materials
(1) Application Form for Special Approval for Innovative Medical Devices
The product name shall comply with the relevant provisions of the "Medical Device Universal Name Naming Rules" and other documents. The performance structure and composition, the main working principle / mechanism of action, and the content of the intended use should be able to reflect all the important information of the product characteristics, concise, concise, professional, and not easy to produce ambiguity.
(II) Applicant enterprise legal person qualification certificate
1. Domestic applicants should submit:
A copy of the copy of the business license and a copy of the organization code certificate (if applicable).
2. Foreign applicants should submit:
The certificate of corporate legal person qualification issued by the competent medical device department of the country (region) where the foreign applicant is registered. Documents must be signed by the original issuing authority or notarized by a local notary.
(3) Product intellectual property rights and supporting documents
1. Provide a description of the intellectual property rights of the core technology of the product. If there are a number of invention patents, it is recommended to display the name of the invention patent, the patentee, and the status of the patent in a list.
2. Provide relevant intellectual property information documents
(1) If the applicant has obtained the Chinese invention patent right, it shall provide a copy of the patent authorization certificate, the claim, the copy of the specification and a copy of the patent registration form issued by the competent authority of the patent.
(2) If the applicant obtains the right to use the invention patent in China by law, he shall provide the copy of the patent authorization, the claim, the specification, and the copy of the patent registration book held by the patentee. The original of the "Certificate of Patent Implementation License Contract" issued by the department.
(3) If the invention patent application has been disclosed by the patent administration department under the State Council and has not been authorized, the publicly available documents of the invention patent signed by the applicant (such as the notice of publication of the invention patent application, the publication of the invention patent application and the substantive examination) Copy of the notice of the stage, the notice of the invention patent entry into the substantive examination stage, etc.) and the copy of the published version of the claim and the manual. In the process of reviewing the application for invention patents, if the claims and instructions are subject to revision by the patent examination department, the revised text shall be submitted; if the patentee changes, the certification documents issued by the competent patent authority shall be submitted, such as a copy of the formalities for the passing of the formalities. .
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