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China Test Laboratory - What are "CMA" and "CNAS"...? - Page 3


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21 cfr part 58 - non-clinical laboratory glp, china, fda (food and drug administration), glp (good laboratory practices), iso 10993 - biological evaluation of medical devices
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  Post Number #17  
Old 14th February 2014, 03:44 PM
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Hershal

 
 
Total Posts: 2,486
Re: China Test Laboratory - What are "CMA" and "CNAS"...?

Quote:
In Reply to Parent Post by MIREGMGR View Post

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 is one of two accrediting bodies (ABs) owned by PRC that accredit labs under ISO/IEC 17025:2005. I know them quite well. CMA I am a bit fuzzy with, but can guess it may be Chinese Law.

BTW, the other AB they have is HKAS, based in Hong Kong.

Hope this helps.

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  Post Number #18  
Old 14th February 2014, 03:48 PM
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Hershal

 
 
Total Posts: 2,486
Re: China Test Laboratory - What are "CMA" and "CNAS"...?

One last here,

Both CNAS and HKAS are Signatories to both the International Laboratory Accreditation Cooperation (ILAC) and to the Asia Pacific Laboratory Accreditation Cooperation (APLAC), which means they are NOT the same as ANAB for these accreditations. They are directly equivalent to IAS, NVLAP, A2LA, UKAS, etc.

ANAB I believe is a Signatory to IAF. CNAS is also a Signatory to IAF for those types of accreditations.

Hope this helps.
Thanks to Hershal for your informative Post and/or Attachment!
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  Post Number #19  
Old 19th December 2016, 12:05 AM
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marmotte

 
 
Total Posts: 26
Re: China Test Laboratory - What are "CMA" and "CNAS"...?

Dear all,

I take the liberty to piggy-back this thread rather than creating a new one ; my question is closely related.

Has anybody ever had experience with Epin Suzhou Ltd?

They seem to have a proper accreditation. At the same time, the scope of this accreditation is huge (see below), and at the same time a bit all over the place. For instance their IP (Ingress) testing is not excluded from 60601-1, but it is excluded from 60601-1-11 - which I can't really understand why.

I am also concerned that they are not better known with such a huge scope.

http://www.testrust.com/image/certif...8/105938_1.pdf

FYI - my focus as of today is 10993 - but I may be interested in their other capabilities too.

THX All.
  Post Number #20  
Old 19th December 2016, 12:45 PM
TravisM71

 
 
Total Posts: 2
Re: China Test Laboratory - What are "CMA" and "CNAS"...?

Not to sure about CMA but CNAS are also IAF and ILAC assured.

CNAS is one of Chinas to go to for conformance testing.

After several years of auditing in China for the UK, I have never come across CMA, but I wasn't involved in FDA or medical devices.
  Post Number #21  
Old 19th December 2016, 11:23 PM
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Raffy

 
 
Total Posts: 848
I Say... Re: China Test Laboratory - What are "CMA" and "CNAS"...?

Is CMA and CNAS related to SCM (South China Center of Metrology - Guangdong Institute of Metrology)? Please advice.

Thanks in advance.
Best regards,
Raffy
  Post Number #22  
Old 20th December 2016, 04:38 AM
TravisM71

 
 
Total Posts: 2
Re: China Test Laboratory - What are "CMA" and "CNAS"...?

as far as I am aware, CNAS is a Chinese Government spin off body. CMA, I think is from a HK manufacturers association.
I would ask for the Labs ILAC certificate, and also, to see the scope of their accreditation.
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