Recently, the Guangdong Food and Drug Administration's Second Class Medical Device Priority Approval Procedures(hereinafter referred to as the “Procedure”) was reviewed and approved by the Legal Affairs Office of the People's Government of Guangdong Province.Since October 1, 2018, this means a new step in the promotion of research and innovation in medical devices in Guangdong Province.
According to the "Procedure", the Guangdong Food and Drug Administration will implement the priority approval for the first registration of the second class of medical devices in the province that meets one of the following conditions:Medical devices that are urgently needed in clinical practice and that are not approved for registration in the province;There are already similar products on the market in the province, but the supply of products cannot meet the medical equipment needed for emergency treatment of public health emergencies;Medical devices that diagnose or treat rare diseases, malignant tumors, and have obvious clinical advantages;Diagnosing or treating the unique and multiple diseases of the elderly, and there are currently no medical devices for effective diagnosis or treatment;Medical devices that are designed for children and have significant clinical advantages;Medical devices listed in the national or Guangdong province's major science and technology projects or national or Guangdong key research and development programs;Guangdong Province's strategic emerging industry backbone enterprises, Guangdong Province through train service key enterprises and other medical equipment manufacturers in Guangdong Province to apply for registration of medical equipment.The bureau also made clear the information required to submit the application for priority approval, which is convenient for the applicant to declare and prepare.
According to reports, the biggest change in the "procedure" is to reorganize the situation of giving priority to approval.Optimize the application procedure for priority approval, better connect with the province's licensing information system, realize automatic reduction and supervision time limit, and ensure that the review and approval resources are properly allocated.At the same time, the requirements for the original registration inspection and technical review speed increase of 20% will be increased to 40%, and the administrative examination and approval time limit will be increased from 40% to 50%.The approval time can be shortened by more than half, highlighting the need to ensure clinically urgent needs and better meet the needs of public medical equipment. There is also a separate clause in the "Procedure", which is to retain the original priority incentives for quality credit class A enterprises.Provide a special registration declaration channel, and no longer need enterprises to submit priority approval applications, wait for online publicity and obtain notices, etc., the reporting process is more convenient and efficient.
It is understood that the Notice of the Guangdong Food and Drug Administration on Printing and Distributing the Priority Approval Procedure for the Second Class of Medical Devices in Guangdong Province (Trial) will be abolished at the same time.The Guangdong Province Second Class Medical Device Priority Approval Process (Trial) was implemented on January 1, 2017.As of May 31, 2018, a total of 151 applications for registration of the second class of medical devices were received.Among them, 138 registration applications entered the priority approval, and 135 were quality credit A enterprises, accounting for 97.8% of all applicants.(Reporter Chen Hairong)