January 3, 2018 In accordance with the "Guangdong Provincial Second Class Medical Devices Priorities Approval Process" requirements, Guangdong Food and Drug Administration intends to agree to preemptively approve these second class medical devices.
Priority approval of the 'benefits'
For the approved medical devices, food and drug supervision, review and licensing departments, in accordance with the early intervention, the person responsible for the scientific approval of the principle of standard Do not reduce, the procedure does not reduce the premise of the approved medical devices to be given priority, and strengthen communication with the applicant.
This applicants, undoubtedly bring great convenience to the product registration and listing of the road, and even set up a VIP fast-track communication with experts at any time, the equivalent of a free authority of the military division, will greatly help businesses in Initial research and development design, product testing, clinical trials, as well as the system involved in the process of verification, registration data preparation, technical review and many other incurable diseases.
Who have this privilege
In January of this year, Guangdong Province received a total of 4 prestigious enterprises with the total number of enterprises, namely Li Tuo Biological Technology Co., Ltd. (2 products), Zhuhai Kang Dela medical instruments (3 products), Shenzhen New Industries Biomedical Engineering Co., Ltd. (16 products), Guangzhou HEDY Medical Equipment Co., Ltd. (1 product), Shenzhen Lei Du Life Science Co., Ltd. (2 products).
Priority declaration reasons are: the previous year by the provincial bureau as a quality credit Class A, and this year is not in production rectification or involved in the processing period, there is no failure to publish medical device quality medical device production enterprise.
Shenzhen New Industrial Biomedical Engineering Co., Ltd. is the most approved manufacturer, which is a state-level high-tech enterprise specializing in the research of chemiluminescence immunoassay. In July last year, it became China's first FDA-certified Chemiluminescent manufacturers.
Guangdong Province in January 2018 preferential approval medical products table
