China Test Laboratory - What are "CMA" and "CNAS"...?

M

MIREGMGR

#1
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"?
 
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Jerry Eldred

Forum Moderator
Super Moderator
#5
Re: China test lab..."CMA" and "CNAS"...?

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.
 
M

MIREGMGR

#8
Re: China test lab..."CMA" and "CNAS"...?

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 Basrur

Staff member
Admin
#9
Re: China test lab..."CMA" and "CNAS"...?

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 :)
 
F

fattyfish

#10
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, you can easily understand the difference. (you also can use google translation)
 
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