One of the major points of the revision of Pharmaceutical Affairs Act is to revise medical device and in-vitro diagnostics regulations to be harmonized with international regulations. The following is related to the revision of Pharmaceutical Affairs Act.
Revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics
Major points of the amendments to the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics include;
1. that the 2nd chapter of the ordinance is completely harmonized with ISO13485: 2003, and
2. that the additional requirements＊ to ISO13485:2003 are described in the 3rd chapter of the ordinance.
＊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．
Contents of New QMS Ordinance (PDF:76KB)
To see the charts(pdf file), it requires a software "Acrobat Reader".
You can get Acrobat Reader for free, please click on the next button. Get Adobe Reader