QMS(Quality Management System)
Manufacturing/quality control for medical devices and in-vitro diagnostic products (referred to as GMP, or Good Manufacturing Practice) is defined in MHLW Ordinance No. 169, known as the QMS Ordinance. This ordinance is mostly consistent with ISO 13485: 2003, but is not completely identical.
(1) QMS conformity as an essential requirement
QMS conformity is an essential requirement for the following two areas under the PAL:
1) Requirements for product approval/certification
During the examination of application documents for approval/certification, a QMS conformity inspection is performed by the relevant review body. Approval/certification is granted only after conformity is established.
2) Requirements for retention of approval/certification
Approval/certification holders are obliged to undergo a QMS inspection every five years. If the approval/certification holder does not fulfill this obligation or does not follow improvement instructions resulting from the QMS inspection, approval/certification may be withdrawn by the relevant authorities.
(2) QMS inspections
QMS inspections are conducted for medical device manufacturing facilities in Japan and in other countries based on the requirements set by the QMS Ordinance. The inspection is performed by PMDA, applicable prefecture or the RCB (registered certification body), according to its application category or other issues.