MHLW MO 169 – Chapter Two/ Section 3 – Management Responsibility
In support of ensuring an effective QMS is sustained in accordance with MO 169, management responsibility should be considered a mission-critical requirement.
MHLW MO 169 – Chapter Two – Quality Management System
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.
MHLW MO 169 – Chapter Two: General Rules
There’s just one takeaway from this week: If your organization already has a QMS premised on EN ISO 13485:2003, then you probably already comply. However, if your organization has identified design and development or product realization as excluded or not applicable within the Quality Manual, then it becomes; “Captain I think we have a problem!”
MHLW MO 169 – Chapter One
Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law.
MHLW Ministerial Ordinance 169
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.
Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.
During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.
Dr. D has just one takeaway from this edition of DG; “Just comply baby!” It does not get any easier than that, well maybe not that easy.
IVDD Annex IX
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
IVDD Annex VIII
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
