Medical network on March 2 - guangdong will charge for the second category of medical equipment product registration.
Published by guangdong food and drug administration of guangdong province pharmaceutical, medical equipment product registration fees related instructions, and effective as of March 1, 2017.
Guangdong food and drug administration fee standards are: for the first time registration fee 81800 yuan; The registration fee RMB 34200; Registration fee of 34000 yuan.
The charge standard according to medical equipment management are also applicable to the in vitro diagnostic reagents.
In addition, the measures for the administration of medical device registration, the registration measures for the management of in vitro diagnostic reagent, belong to register to apply for a change of circumstances, is not a change registration fee.
Conforms to the small and medium-sized enterprises (smes) row type standard provisions (ministry of united enterprises [2011] no. 300) conditions of the registration of the applicant, identified as belonging to apply innovative medical device product registration, can apply to waive the registration fee for the first time.
After the registration rejected, the applicant voluntarily withdraw the application for registration, or to deny permission decision drug safety, already paid the registration fee. The applicant ask for product registration, it shall pay the registration fee again.
Note that guangdong food and drug administration, registration applicant shall upon receipt of the non-tax revenue payment notice within five working days after pay the registration fee in accordance with the requirements, not according to requirements of pay, its registration procedure to stop; Registered applicants over 30 working days from the date of acceptance is still required to pay the registration fee, as the applicant offered to withdraw the application for registration, the registration process to terminate.
17 provinces charge standard
Nationwide, guangdong is a 17 provinces for the second category of medical device registration fees.
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