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Hi all, I hope someone can help me iunderstand what a customer is requesting of me. I received a fax today with the following request-this company is in Japan and purchases finished goods from us. I think they want us to supply them with test results for each lot sent but ???
"Test on the products being imported from you has been implemented based on the testing method described in the written acknowledgement for which we applied to the Ministry of Health, Labor and Welfare.
In the new medical law, the test method will be changed as follows-your company (thats me) shall implement tests conforming to ISO 13485-2003 (regarding test items, our method having been implemented will be allowed), and the result of the test shall be attached by the lot in each export."
Ok, the way I understand this is puzzling, I do not recall specific test methods within 13485 or have I missed something?They states they will send the testing method to me after they translate it. Does anyone have any ideas to share about this?
Thanks,
Bridget
"Test on the products being imported from you has been implemented based on the testing method described in the written acknowledgement for which we applied to the Ministry of Health, Labor and Welfare.
In the new medical law, the test method will be changed as follows-your company (thats me) shall implement tests conforming to ISO 13485-2003 (regarding test items, our method having been implemented will be allowed), and the result of the test shall be attached by the lot in each export."
Ok, the way I understand this is puzzling, I do not recall specific test methods within 13485 or have I missed something?They states they will send the testing method to me after they translate it. Does anyone have any ideas to share about this?
Thanks,
Bridget
and is based on GHTF recommendations published on the ghtf.org website.