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MIREGMGR
We're a US medical device maker with a separate wholly-owned company and plant in China, which so far has been doing only contract manufacturing for us. We've recently had their people obtain some ISO 10993 biocompatibility test data for a candidate material we might want them to begin sourcing and using.
The lab utilized by the candidate vendor was Inspection and Testing Center of Soochow University Radiation Medicine Institute. Their report states conformance to "CMA" (which is identified in Chinese, for which we currently have no US in-house translation) and to "CNAS" (not otherwise identified).
Otherwise, the test report looks good. They did the right tests, and appear to have done them in a technically suitable way.
In order for this testing to be useful for us in regard to our EU MDD conformance, it must have been done under a 17025 certificate with appropriate scope for the test period. It also must be certified consistent with the FDA's Good Laboratory Practices (GLP) 21 CFR 58.
Obviously we're pursuing further information from ITC directly, and from our associates in China. In the meantime, anyone have knowledge of the significance of "CMA" and "CNAS"?
The lab utilized by the candidate vendor was Inspection and Testing Center of Soochow University Radiation Medicine Institute. Their report states conformance to "CMA" (which is identified in Chinese, for which we currently have no US in-house translation) and to "CNAS" (not otherwise identified).
Otherwise, the test report looks good. They did the right tests, and appear to have done them in a technically suitable way.
In order for this testing to be useful for us in regard to our EU MDD conformance, it must have been done under a 17025 certificate with appropriate scope for the test period. It also must be certified consistent with the FDA's Good Laboratory Practices (GLP) 21 CFR 58.
Obviously we're pursuing further information from ITC directly, and from our associates in China. In the meantime, anyone have knowledge of the significance of "CMA" and "CNAS"?