Seminar on the in Vitro Diagnostic Reagents Classification Subdirectories Implementation Held in Beijing

  • 2017-07-31

Considering the high attention of our IVD members to the adjustment of the CFDA on the directory of some in-vitro diagnostic reagents, and the problems during implementation of the IVD reagents classification subdirectories issued in 2013 by the CFDA, with the intention of setting up a good communication platform between enterprises and the government, the IVD Branch of CAMDI held a seminar on the implementation of IVD reagents classification subdirectories on July 27, 2017 in Beijing. The leaders of Standards Management Center of CFDA, some domestic and foreign capital IVD enterprises were invited to attend the meeting.

The meeting focused on the explanation and suggestions to the problems occurred during implementation of IVD reagents classification subdirectories, as well as discussion of the effective communication mechanism between the parties. The enterprises paid high attention to the meeting and collected data in advance. During the meeting, the participants spoke out freely on the IVD directory adjustment, inconsistent filling name of Class I products, inconsistent name with the medical insurance directory due to name change, the product directory failing to be managed as medical device and no publication of classification after 2015, and came up with some constructive opinions and suggestions.

The seminar got supports and acceptance, and it helped the enterprises accommodate to new regulatory situation and solve the problems during industry development. It was also a beneficial attempt to set up an effective communication channel between enterprises and the government.