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"?

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)....

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.

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

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.

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 (http://www.strquality.com/monitor/STR_Shanghai_Obtains_Certificate_for_CMA.pdf)

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

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?

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?

That ppt seems to be old .... prepared on 11/9/2006 4:51 PM :)

CMA （the translation is correct）is generally for the organization who provides the notarial data, i.e., the report from CMA certified organization is endowed with legal validity.
CMA certification is based on some Chinese metrology laws, and CNAS is based on ISO 17025.
If you can read Chinese and visit the URL: cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml (http://www.cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml), you can easily understand the difference. (you also can use google translation)

CMA （the translation is correct）is generally for the organization who provides the notarial data, i.e., the report from CMA certified organization is endowed with legal validity.
CMA certification is based on some Chinese metrology laws, and CNAS is based on ISO 17025.
If you can read Chinese and visit the URL: cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml (http://www.cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml), you can easily understand the difference. (you also can use google translation)

Thank you for your input and clarification.

CMA （the translation is correct）is generally for the organization who provides the notarial data, i.e., the report from CMA certified organization is endowed with legal validity.
CMA certification is based on some Chinese metrology laws, and CNAS is based on ISO 17025.
If you can read Chinese and visit the URL: cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml (http://www.cnca.gov.cn/rjwsysb/xgxz/glxxgb/597.shtml), you can easily understand the difference. (you also can use google translation)

Many thanks !

CNAS is based on ISO 17025.

In other words, authority to (properly) place the CNAS logo on a lab's report would imply that the lab is certified to ISO 17025 with a scope that includes the subject of that report?

I can't find a reference to such an authority or relationship on their English-language-version website...is there a link to such information?

By any chance, does CNAS certification also imply conformance to FDA GLP (21 CFR 58)? I don't find any mention on their website of FDA mutual recognition, either.

In other words, authority to (properly) place the CNAS logo on a lab's report would imply that the lab is certified to ISO 17025 with a scope that includes the subject of that report?

I can't find a reference to such an authority or relationship on their English-language-version website...is there a link to such information?

By any chance, does CNAS certification also imply conformance to FDA GLP (21 CFR 58)? I don't find any mention on their website of FDA mutual recognition, either.


The English site is under construction- always.

Here is some information from Chinese web.

As you know, CNAS is a combination of CNAL and CNAB, so lab accreditation is only a part of job of CNAS. Even for lab accreditation, there are several types:


Testing and calibration lab - China guidance CNAS - CL01 （=ISO 17025）http://219.238.178.51/bx90/sites/cnas/extra/col23/1153719823.pdf from first page you could know it is identical to ISO 17025
Medical lab - CNAS - CL02 (ISO 15189)
Safety of medical lab - CNAS - CL36 (ISO 15190)
Lab biosafety - CNAS-CL05 (GB 19489, China National Standard)
Reference Material Producers - CNAS - CL04
Providers of Proficiency Testing Schemes - CNAS - CL03 (ILAC G13)

The logo usage guidance: http://219.238.178.51/bx90/sites/cnas/extra/col23/1176714243.pdf
Once the lab/organization is accredited, CNAS will issue a "accreditataion logo", which including a CNAS logo, the acredited type (testing, management system, calibration etc) and an ID number. The accreditataion logo can be only used with in the accredited scope. Thus, an ISO 17025 certified lab could use a CNAS logo with a word "testing" or "calibration".
I uploaded example logoes. Please note the left is a Chinese version, right English. "CNAS LXXXX" is the accreditation ID, L means laboratory.

CNAS is a member of IAF and ILAC, and IAF or ILAC logo may be combined with a CNAS logo. The combined logo can be used only if authorized by CNAS (there will be a documented agreement between CNAS and the lab/organization).

For FDA's GLP, I don't think CNAS is able and willing to do that. The mutual recognition of GLP should be a job between US FDA and China SFDA (State FDA). As I know, FDA doesn't have a MOU on GLP with SFDA. Refer to the FDA's web site http://www.fda.gov/oia/