In order to streamline the registration process for medical devices, the State Food and Drug Administration (SFDA) issued the Notice on Issues concerning the Administrative Documents for the Registration of Medical Devices, the Notice) on September 16, 2008. The Notice repeals several administrative provisions issued before the Measures for the Administration of Medical Device Registration, the Measures). SFDA promulgated the Measures on August 9, 2004 as an overarching regulation on the registration of medical devices in China. The Notice also specifies that certain large medical devices may be approved for registration upon import and undergo the necessary testing afterwards.
Under the Notice, the following provisions were repealed: (1) The Provisions for the Examination of Market Access for Medical Devices issued on January 6, 1996 and its Appendixes; (2) The Interim Provisions for the Clinical Verification of Medical Devices issued on July 17, 1997; (3) The Provisions on the Registration and Inspection of Imported Medical Devices issued on March 14, 2001; (4) The Notice on the Supplementary Explanations for the Registration of Imported Medical Devices and Class III Domestic Medical Devices issued on November 8, 2001; (5) Supplementary Provision I for the Registration of Medical Devices issued on July 24, 2004; and (6) Supplementary Provision II for the Registration of Medical Devices issued on March 30, 2003.
The Measures provide that a petition may be submitted to postpone the pre-registration testing in China of certain large medical devices that have been approved for commercial use by SFDA’s foreign counterparts. Accordingly, the Notice specifies that certain medical devices may be tested after their registration has been approved. These devices include computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), and medical nuclear magnetic resonance imaging (MRI) systems, as well as large color Doppler ultrasound diagnostic devices and large X-ray diagnostic devices. Additionally, according to the Notice, when applying for the registration of condom products that comply with the national standard, applicants do not need to present clinical trial documents.