China Food and Drug Administration cancels the registration certificate of medical devices for four

On April 24, the China Food and Drug Administration issued a notice on canceling the medical device certificate (No. 54 in 2020), canceling the medical device registration certificate of four products.

According to the announcement, according to the provisions of the administrative measures for registration of medical devices and the application of the enterprise, the anti HBE test kit (chemiluminescent immunoassay) of gxzz 20173400149 and the HBeAg test kit (Chemistry) of gzz 20173400134 of Suzhou Changguang Huayi Biomedical Engineering Co., Ltd. are cancelled Luminescent Immunoassay, the anti HBC test kit (chemiluminescent immunoassay) of GXS 20173400160 and the registration certificate of four products of GXS 20173256332 high frequency electrotome of Meilun medrange Corporation.