Technical Requirements
For the registration (filing) of IVD
reagents, technical requirements should be prepared in accordance with national
standards, industry standards and relevant literatures based on results of
product development and clinical evaluation, on the condition that quality of
raw materials and manufacturing process for the product are stable.
Technical requirements include performance
specifications and test methods of finished products of IVD reagents, where
performance specifications means the functional and safety specifications and
other specifications related to quality control of the finished product that
can be objectively determined.
In technical requirements for class III IVD
reagents, main raw materials, manufacturing process and requirements for
semi-finished products should be specified in the form of appendix.
Registration Testing
Registration testing is required for the
registration of class II and III IVD reagents; for class III reagents, three
consecutive batches should be tested. Tests should be conducted as per
technical requirements of the product by MD testing facilities.
Samples for registration testing should be
manufactured in compliance with the requirements of quality management system.
Only those that pass registration testing can be proceeded to clinical trials
or registration application.
For the filing of class I IVD reagents,
self-test reports can be provided.