China: Medical Device/In Vitro Diagnostic Clinical Trials Update

China: Medical Device/In Vitro Diagnostic Clinical Trials Update

 

On July 30, 2014, the China Food and Drug Administration (CFDA) released detailed information on implementing the revised Regulations on the Supervision and Administration of Medical Devices.  Order No. 4 covers Administrative Measures for Medical Device Registration, and Order No. 5 covers Administrative Measures for the Registration of In Vitro Diagnostic Reagents.  These administrative measures include updated guidelines for clinical trials, which will go into effect starting on October 1, 2014.

 

Order No. 4: Administrative Measures for Medical Device Registration

To apply for Class II and Class III Medical Device registrations, clinical trials should be conducted.  The following situations are exempt from conducting clinical trials:

  • The product has a clear working mechanism, finalized design, and mature production technology.  A medical device of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events.  There will also not be any changes to the product’s conventional usage;
  • The safety and efficacy of the product can be proven through non-clinical evaluations;
  • The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.

 

The catalogue of medical devices that are exempt from conducting clinical trials is still to be formulated, revised, and published by the State Food and Drug Administration.

 

Order No. 5: Administrative Measures for the Registration of In Vitro Diagnostic Reagents

To apply for the registration of Class II and Class III in vitro diagnostic products, clinical trials should be conducted.  The following situations are exempt from conducting clinical trials:

  • The product has a clear reaction principle, finalized design, and mature production technology.  An in vitro diagnostic product of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events.  There will not be any changes to the product’s conventional usage, and the applicant can provide the evaluation and data on the efficacy of the product that is already on the market.
  • The safety and efficacy of the product can be proven through the evaluation of clinical samples that cover the intended use and interference factors.

 

The catalogue of in vitro diagnostic products that are exempt from conducting clinical trials is still to be formulated, revised, and published by the State Food and Drug Administration

 

For full translations of these two administrative orders into English, please see PBM’s blog posts for Administrative Order No. 4 on medical device registrations and Administrative Order No. 5 on in vitro diagnostic registrations.