On May 30, 2014, CFDA issued an
announcement where detailed regulation on Class I MD filing is specified.
If you need to know more about the
latest regulations or to have professional insights about the regulation,
please contact us via:
Tel: 86-10-62253808
Email: service@qiminer.com
According to the announcement, for devices that have been approved
for class I MD registration before June 1 and are listed within Class I MD
directory or IVD reagent subdirectory, the applicant shall conduct filing
within the validity of registration certificate. For applications accepted
before June 1, CFDA will not continue registration review process. The
applicant shall withdraw its application request and reclaim its application
data from CFDA.
Details