Chang-Hong Whitney06.06.07
The newest release of the IVD regulation sounds very much like a drug registration again—although products now are to be considered as medical devices. In-Vitro Diagnostic Reagent Registration Management Methods (Trial Version), released April 19, outlines the key components in the IVD reagent registration process. This regulation covers all reagents except those that are used for blood selection or those that use radioisotope markers.
In this new regulation, IVD reagents are classified into three categories, based on risk. Class III products (the highest risk level) include reagents for testing of disease antigens, antibodies and enzymes; human genetic testing; drug target identification; cancer markers; and drug allergy testing reagents. Class I reagents (the lowest risk products) include growth media and sample preparation reagents, such as solvents or diluting fluids. Any reagents that are not clearly identified as Class III or Class I are in the Class II category.
Class II and III products are required to have completed in-China clinical studies and reports prior to registration. (Class III products must be tested in three clinical trial sites prior to registration.) In addition, these products must undergo type testing at SFDA authorized laboratories. Samples of three consecutive batches are to be submitted for testing.
As for registration itself, the following information is required:
1. Product information
• General description of the product, such as intended use, the product’s technical theory, key raw material source and manufacturing process, biosafety and information on similar products already on the market
• User’s manual
• Product standard
• Type testing report
2. Production and analysis information
• Information on raw materials
• Key production processes and analysis reports
• Performance evaluation
• Stability report
• Clinical study reports
• Production report for three consecutive batches
• Product packaging and label samples
3. Manufacturer’s credentials, China agent information and statements
• Manufacturer’s licenses
• Home market product release information
• Quality system certification
• China agent’s authorizations and approvals (service agent, legal representative, registration agent)
• Statement of truthfulness and guarantees
While the SFDA has made a big step in the right direction by grouping IVD reagents into the medical device category, its registration requirements seem to be quite extensive. Discussions with the agency on this new issue have been difficult, as SFDA members are trying to refine the details. It is believed (as of press time) that the June 1 implementation is a set target for all IVD products to be registered. This regulation is bound to evolve, and more developments will be reported as they come up. Stay tuned...