According to 《Provisions for the Registration of Medical Devices》 (No.16 Order of SFDA )(2004-08-09),all MD reagents including class I,II,III and imported MDs should be registered in sFDA. Class I should be registered in municipal sFDA, class II should be registered in provincial sFDA, class III and imported MDs should be registered in national sFDA. National class II,III and part imported MDs should carry out clinical trials. We can provide “serve first, pay second” style regarding to the good credit company! Flow chart for MDs’s registration is as followed.
1 Confirm applicant’s requirements.
2 Draft products’ standard.
3 Contact with testing institute for products’ testing.
4 Carry out MD’s clinical trial.
5 File all application materials.
6 Submit all data to local or national sFDA for evaluation.
7 Follow evaluation and then obtained Registration Certificate.