Technical Requirements
Product technical requirements should be
prepared for medical devices to be registered or filed.
Product technical requirements mainly
include performance specifications and testing methods of MDs (finished
products), where performance specifications refer to functional and safety
specifications and other specifications related to quality control.
Guidelines for the
compiling of MD product technical requirements
Testing
Registration testing is required for the
registration of class II and III medical devices, which 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 medical devices,
self-test reports can be provided.
Testing
ranges of MD testing centers