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Revision of Japanese Medical Device QMS requirements

Contents of the revision

Major points of the revision to “the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics” (MHLW MO 169) include that:
 1) The 2nd chapter of the ordinance is completely harmonized with ISO13485: 2003 (see item 3), and
 2) The additional requirements to ISO13485:2003 are described in the 3rd chapter of the ordinance (see item 3).

The additional requirements include a marketing authorization holder to check manufacturing sites for the compliance of the standards, retention periods of obsolete documents and records, and establishment of adverse event reporting system.

The new regulations has come into force since 25 November 2014.




JCN 3010005007409

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Revision of Japanese Medical Device QMS requirements