Biocompatibility Evaluation Of Active Medical Devices Such As Patient Monitor With Multiple Accessories In Contact With Body

As per NMPA CMDE Department 1, for the patient monitor and other active medical devices containing more accessories in direct/indirect contact with human body, in the aspect of biocompatibility evaluation in the process of potential biological risk management, it is suggested that the biological evaluation of accessories should be divided into the following three cases:

1. In case of exemption from biocompatibility evaluation, it is recommended to issue a statement with reference to CFDA [2007] No. 345, describing no circumstances occurring specified in Article 4 (1):
   Article 4 (1) The manufacturer shall consider re-evaluation of biosafety under the following circumstances:
   a. Changes in the sources of materials or technical conditions used to manufacture products;
   b. Changes in product formula, process, primary packaging or sterilization;
   c. Changes in the final product during the storage period;
   d. Changes in the use of the product;
   e. When there are indications that the product will produce adverse reactions when used in human body.
2. In case of biocompatibility evaluation, it is recommended to select and evaluate the accessories according to the biological evaluation procedure in the risk management process shown in the systematic approach diagram in GB / T 16886.1-2011.
3. In case of biocompatibility test, it is recommended to identify the data or tests that need to be supplemented to the complete data set for risk assessment according to Appendix A of GB / T 16886.1-2011 Biological Evaluation Tests.
   

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