Medical network - on February 17, to implement the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), the medical equipment examination and approval procedures for priority (the state food and drug administration bureau announcement no. 168, 2016), and further do a good job in writing) filings medical instrument prior approval administration of state food and drug supervision and administration to make the materials of medical apparatus and instruments prior approval notification writing guidelines (try out)" (attachment), are hereby issued.
Please take note.
Attachment: medical instrument prior approval notification data writing guidelines (trial)
The food and drug supervision bureau
On February 15, 2017
Medical equipment prior approval notification data writing guidelines (trial)
To regulate the priority request for approval of medical equipment, improve the quality of the filing, according to the medical equipment preferred examination and approval procedures, this guide.
A, content requirements
(a) application form for examination and approval of medical equipment is preferred
Specified product is suitable for the medical equipment examination and approval procedures for priority what situation stipulated in article 2, outlining the reason for examination and approval of priority.
(2) medical device registration application form copy
(3) in accordance with article 2 of the medical equipment preferred examination and approval procedures for the first (1) situation of medical apparatus and instruments priority request for approval, shall be provided in accordance with the requirements of the following information:
1. The diagnosis or treatment of rare diseases, and has obvious clinical advantages
(1) the product indications of the incidence data and relevant supporting data;
(2) show that the indications of rare diseases supportive data;
(3) the status quo of clinical treatment of the indications were summarized;
(4) the product is existing products or treatment has obvious advantages in clinical instructions and related supporting information.
2. The diagnosis or treatment of malignant tumor, and has obvious clinical advantages
(1) the product indications of malignant tumor supporting data;
(2) the status quo of clinical treatment of the indications were summarized;
(3) the product is existing products or treatment has obvious advantages in clinical instructions and related supporting information.
3. The diagnosis or treatment of aged and multiple disease, and there is no effective diagnosis or treatment
(1) the product indications are aged and multiple diseases supportive data;
(2) the status quo of clinical treatment of the indications were summarized;
(3) there is no effective diagnosis or treatment instructions and relevant supporting documents.
4. Dedicated to children, and has obvious clinical advantages
(1) the product indications of childhood diseases supportive data;
(2) the status quo of clinical treatment of the indications were summarized;
(3) to prove that the product is special for diagnosis or treatment of childhood diseases, the existing products or treatment has obvious advantages in clinical instructions and related supporting information.
5. Urgent clinical needs, and in our country, there is no medical instrument with varieties of products are allowed to register
(1) the status quo of clinical treatment of the product indications, elucidate the reasons for urgent clinical needs.
(2) approved by the product and similar products abroad and clinical usage;
(3) provide to retrieve the situation shows that the current domestic no associated with varieties of products are allowed to register, and there is no similar alternative diagnosis or treatment.
(4) in accordance with the medical equipment examination and approval procedures for priority (2) of article 2 of the situation of medical apparatus and instruments priority request for approval, and shall provide the following information:
1. The product is listed in the national science and technology major projects or the national key research and development plan of medical apparatus and instruments;
2. The relevant supporting material, such as project specification, etc.
(5) of the submitted information authenticity of self assurance statement
Domestic product application issued by the applicant, the import product application issued by the applicant and the agent, respectively.
Second, the format requirements
(a) provided by the guide should indicate the sequence arrangement and a binder.
(2) should be submitted data directory, including declaration data of primary and secondary title. Each secondary corresponding information should be compiled separately page title.
(3) medical device is preferred in application to declare materials without special instructions, all should be original, and the applicant's signature. "Signature" refers to: enterprise stamp, or its legal representative, director signature and company stamp.
(4) imported medical equipment application priority claim data without special instructions, the original information should be signature by the applicant, Chinese language materials from the proxy signature. Original data "signature" means: the legal representative or person in charge of the applicant, the signature, or the signed and sealed by the organization, and shall be submitted by the applicant issued by the local notary public notary; Chinese language materials "signature" means: agent official seal, or his legal representative, head of the signature and stamp.
(5) written by the applicant files according to the A4 size paper printing, the font size is suitable for reading.
(6) a copy of the declaration data using, should be clear and consistent with the original copy. Color images, charts, color copy should be provided.
(7) declaration data shall be kept in the Chinese language. As a foreign language, it shall have the Chinese version. |
