2020年6月，FAMIDOC TECHNOLOGY CO.,LTD has been obtained the MDSAP (ISO 13485:2016) medical device quality system certificate issued by the SGS United Kingdom Ltd, valid until June 2023.
In June 2017, SGS issued the first MDSAP certificate in mainland China for FAMIDOC TECHNOLOGY CO.,LTD.MDSAP (Medical Device Single Audit Program) integrates the contents of ISO 13485:2016 edition and the special requirements of Brazil, the United States, Australia, Japan and Canada for medical device quality management system, including: Brazil RDC ANVISA 16/2013, the United States 21 CFR Part 820, Australia TG (MD) R, Japan MHLW MO169 and Canada SOR/98-282, as well as the special requirements of MDSAP, Mdsap's Single Audit is performed by MDSAP's authorized audit body (e.g. SGS), replacing the current multiple audits or factory inspections. Regulators in the MDSAP program will use MDSAP audit results from third-party auditors to replace the current pre-marketing process audit or factory inspection of medical device manufacturers by various regulators.
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