09.05.12
DMAH Responsibilities and Requirements
The MAH or DMAH structure is composed of three controllers. The quality assurance controller supervises the good quality practice of the products, and the post-marketing Safety controller is charged with good vigilance practice. The general manager supervises all the MAH responsibilities and is the guarantor of product quality, safety standards, and marketing. The number of required personnel for a MAH or DMAH is dependent upon the classification of the medical device. One person can be a MAH or DMAH for general devices (Class I), and he or she would perform all the necessary duties of the three controllers. Two people are necessary for a MAH or DMAH of controlled devices (Class II). One is the post-marketing safety controller, and the other is the quality assurance controller. One of these two people also must be the general manager. Finally, three people are required for highly controlled devices (Class III and IV), with each assigned as one controller.
Should an adverse event occur, it is the job of the three MAH controllers to decide how and when the event should be reported to the PMDA. In the end, the PMDA determines the methods and requirements of dealing with adverse events, which it currently does on a case-by-case basis.
The MAH or DMAH structure is composed of three controllers. The quality assurance controller supervises the good quality practice of the products, and the post-marketing Safety controller is charged with good vigilance practice. The general manager supervises all the MAH responsibilities and is the guarantor of product quality, safety standards, and marketing. The number of required personnel for a MAH or DMAH is dependent upon the classification of the medical device. One person can be a MAH or DMAH for general devices (Class I), and he or she would perform all the necessary duties of the three controllers. Two people are necessary for a MAH or DMAH of controlled devices (Class II). One is the post-marketing safety controller, and the other is the quality assurance controller. One of these two people also must be the general manager. Finally, three people are required for highly controlled devices (Class III and IV), with each assigned as one controller.
Should an adverse event occur, it is the job of the three MAH controllers to decide how and when the event should be reported to the PMDA. In the end, the PMDA determines the methods and requirements of dealing with adverse events, which it currently does on a case-by-case basis.