Case Study 26 : ISO 13485 Suppliers Audits in China for a Mexican Medical Device Company

Company Situation

The Client is a Medical Device Manufacturer based in Mexico, that wants to buy some medical device parts from suppliers in China. To comply with ISO13485 requirements, the manufacturer has to audit the suppliers in china, assess their quality management system before qualifying and start using their products.
Since the Client was based in Mexico, and because of the language barrier as the audits needed to be performed in Chinese, the client was looking for a partner who could perform a QMS ISO 13485 audit in China in Chinese language but provide the audit report in English to the client.

GRP Solution

GRP provided 2 qualified QMS auditors in china who speak Chinese and English, and who were able to perform 3 ISO13485 audit at 3 different manufacturing sites in China. Both auditors spoke and wrote good English, so they were able to communicate audits findings to manufacturer in Mexico and write audit reports in English as per agreed timelines.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).