China test laboratory - What are "CMA" and "CNAS"...?

[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"?

[Ted Schmitt]

In Reply to Parent Post by 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"?

CNAS = China National Accreditation Service (http://eng dot cnas dot org dot cn) is the equivalent to ANAB I believe...

and CMA can´t really pinpoint what it is (found anywhere from China Meteorology Adminstration to China Meat Association)....

[Jerry Eldred]

You are quick. I'll venture a guess on CMA of Chinese Medical Association based on the context. Their web address is www.chinamed.com.cn

Not a sure thing, but seems to be a good possibility.

[Ajit Basrur]

Ted is correct with CNAS; however CMA is "China Measurement Accreditation"

[Jerry Eldred]

I don't doubt your input. But regarding "China Measurement Accreditation" being the answer for "CMA", I've looked in the various MRA websites and can't find them anywhere. Do you know of a website or any MRA they associate with? Or if perhaps this is a purely Chinese function not associated with MRA's? If the latter is the case, the CMA wouldn't then be usable for international compliance.

[Ajit Basrur]

In Reply to Parent Post by Jerry Eldred

I don't doubt your input. But regarding "China Measurement Accreditation" being the answer for "CMA", I've looked in the various MRA websites and can't find them anywhere. Do you know of a website or any MRA they associate with? Or if perhaps this is a purely Chinese function not associated with MRA's? If the latter is the case, the CMA wouldn't then be usable for international compliance.

Sorry, its China Metrology Accreditation - pls see HERE

[Ajit Basrur]

I got this interesting ppt on Standards and Conformity Assessment Bodies - China - strangely there is no mention of CMA !!!

[MIREGMGR]

Ajit, that PPT separately lists CNAT, CNAL and CCIC, and doesn't list CNAS.

The CNAS website suggests that they were formed by the merger of CNAT, CNAL and CNAB. I haven't found a date yet.

Do you know the date of that PPT?