Verification storm, Roche and other equipment to withdraw a large number of 169 large number of applications
January 3, 2016 A total of 169 applications were withdrawn by 261 companies from December 13, 2016 to December 15, 2017. Of these, 42 companies withdrew 105 applications for registration of in-vitro diagnostic reagents ( Table 1), 127 companies withdrew 156 other medical device registration applications (Table 2).
Table 1: Withdrawal of IVD Application Register
Serial number
Acceptance number
product name
applicant
1
Into 15-4466
Squamous cell carcinoma antigen test kit (Electrochemiluminescence)