Medical network - January 6 December 30, 2016, guangdong food drug administration issued about print and distribute the second category of medical device is preferred in guangdong province approval procedures (try out) "notice (cantonese food drug safety do make [2016] no. 579) (hereinafter referred to as the" notice ").
"Notice" pointed out that the circular file, is in order to ensure medical devices for clinical use demand of guangdong province, meet the demand of the public with machinery, promote healthy development of the medical equipment industry in guangdong province.
Examination and approval procedures, stressed that meet the conditions for the relevant jurisdiction in the province the second category of medical device registration application for the first time the implementation of priority for examination and approval. And, for the prior approval of the project, sorted by receiving time alone, priority, technical review, inspection time respectively in legal requirements to cut by more than 20%, administrative examination and approval time limit shrink more than 40% of the legal requirements.
The approval process has been shall become effective as of January 1, 2017.
Examination and approval procedures for the second category of medical device is preferred in guangdong province (trial) ", marks the guangdong province in promoting medical equipment review for examination and approval system reform on the journey of a major step forward again! Is also as a result, the guangdong YiXie people will in the later YiXie administrative examination and approval, etc, to enjoy more benefits!
The following as the "notice" and the examination and approval procedures for the full text, for your reference:
About print and distribute the second category of medical device is preferred in guangdong province approval procedures (try out) "notice
Around the stage to food and drug administration, ShengJu review certification center, provincial medical equipment quality supervision and inspection:
In order to ensure the guangdong medical instrument clinical use requirements, meet the demand of the public with machinery, promote the healthy development of the medical equipment industry in our province, according to the regulations on the supervision and administration of medical devices (state council order no. 650), the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) and the administration about the announcement of the release prior approval process of medical equipment in no. 168 (2016), and other relevant provisions, inform to make the examination and approval procedures for the second category of medical device is preferred in guangdong province (trial), and hereby printed and distributed to you, please comply with them.
Attachment: the second category of medical equipment in guangdong province prior approval procedures (trial)
Guangdong food and drug administration office
On December 21, 2016
The second category of medical equipment in guangdong province priority for examination and approval procedures (trial)
Article 1 in order to guarantee the guangdong medical instrument clinical use requirements, meet the demand of the public with machinery, promote the healthy development of the medical equipment industry in our province, according to the regulations on the supervision and administration of medical devices (state council order no. 650), the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) and the administration about the announcement of the release prior approval process of medical equipment in no. 168 (2016), and other relevant provisions of these procedures.
Article 2 provincial food and drug administration (hereinafter referred to as ShengJu) to meet the following conditions, one of the provincial jurisdiction for the first time the second category of medical devices registration approval application implementation of priority:
(a) urgent clinical needs, and in this province, there is no medical apparatus and instruments, with varieties of products are allowed to register or is listed on the existing similar products in the province, but the supply can not meet the needs of the public health emergencies emergency treatment;
(2) the diagnosis or treatment of rare diseases, malignant tumor, and has significant clinical advantage of medical apparatus and instruments;
(3) the diagnosis or treatment of the elderly, children's characteristic and multiple diseases, and there is no effective diagnosis or treatment of medical apparatus and instruments;
(4) listed in the state, the guangdong science and technology major projects or the state, the major research plan of medical apparatus and instruments;
(5) the strategic emerging industry backbone enterprises of guangdong province, the through train service key enterprises, such as guangdong province key support of application for registration of medical devices; medical device manufacturing enterprise
(6) was voted ShengJu quality class A credit from the previous year, and this year is not in production during the rectification or involved in processing, no medical instrument quality announcement unqualified medical device manufacturing enterprise;
(7) other shall give priority to the examination and approval of medical devices.
Article 3 the second article to conform to this procedure (a), (2), (3), (4), (5), (6), the applicant shall submit a medical device registration application submitted prior approval application form (see appendix 1).
For this program (4) the second article, the situation of medical apparatus and instruments is preferred (5) apply for examination and approval, the applicant shall also submit relevant documents.
Article 4 ShengJu for medical device registration acceptance department to review form of priority for examination and approval of the application materials, the priority for examination and approval of the application materials are complete and shall accept the application for registration of the project, indicate the priority request for approval, ShengJu for review.
Article 5 for this program in article 2 of the first (4), (5), (6) of the situation of medical apparatus and instruments is preferred for examination and approval of application, ShengJu within five working days from the date of receiving the application for review, in conformity with the preferred examination and approval conditions, to give priority for examination and approval.
For this procedure (a), (2) the second article, (3) of the medical equipment priority request for approval and shall give priority to the approval of other medical apparatus and instruments, expert argumentation ShengJu organization audit, issue the audit opinion. By experts required prior approval, the argument for prior approval.
Article 6 ShengJu will draw up the priority for examination and approval of projects of the applicant, name of product, to accept the number shall be published on its web site, the public time shall be not less than five working days. Public notice period without objection, the priority in the process of review, the results of audit by ShengJu written notice to the applicant (see format in annex 2).
Article 7 to object to the public project, it shall, in the public notice period to ShengJu submit written opinions and reasons (objection to see annex 3). ShengJu shall be within 10 working days after receipt of the objection, the study of the related opinions, and shall inform the applicant and the objection to study the opinions.
Article 8 ShengJu audited shall not approval, the priority will be the priority for examination and approval opinions and reasons to inform the applicant, and according to the regular examination and approval procedure.
Article 9 for the first approval of the project, sorted by receiving time alone, priority, technical review, inspection time respectively in legal requirements to cut by more than 20%, administrative examination and approval time limit shrink more than 40% of the legal requirements.
Article 10 for the first approval of the project, ShengJu review certification center in the process of technical evaluation, shall, in accordance with the relevant provisions, actively communicate with the applicant, when necessary, can arrange special communication.
Article 11 already, according to the examination and approval procedures for emergency medical devices (the food drug safety machinery [2009] no. 565), "the innovation medical instrument special approval procedures (trial)" (drug safety food machinery tube [2014] no. 13), the second category of innovative medical devices in guangdong province special approval procedures (trial) "(food drug safety office machinery note [2015] no. 511) for examination and approval of registration project, does not perform this procedure.
Article 12. The program shall be implemented as of January 1, 2017. |
