Ohayou Gozaimasu (look-it-up) my dear readers. Thank you for joining the doctor for this week’s episode of Devine Guidance (DG).
In this edition DG, Dr. D will lay down the foundation for the series on complying with MHLW Ministerial Ordinance 169 (MO 169). For those of you that did not have the chance to read last week’s column by the doctor, MO 169 is the Japanese Ministerial Ordinance on Standards for manufacturing Control and Quality Control for Medical devices and In-Vitro Diagnostic Reagents. MO 169 is comprised of five Chapters, six Sections, and 80 Articles.
In general, MO 169 is the foundation for Quality Management System (QMS) requirements required for device manufacturers wishing to enter product into Japan. Unlike EN ISO 13485:2003, MO 169 compliance is categorized as an accreditation for foreign manufacturers and a licensure requirement for domestic Japanese manufacturers. As Dr. D dives into the meat of MO 169 and provides guidance on sustaining compliance and successfully navigating audits from the Pharmaceuticals and Medical Devices Agency (PMDA), you will quickly realize the similarities when compared to EN ISO 13485:2003.Hopefully the readers will grasp the differences as well, because failure to do so will leave a device manufacturer on the outside looking into the missed window of opportunity in regards to product entry into the Japanese Market.
What device manufacturers need to know
For starters, MO 169 is broken down into five distinct chapters:
- Chapter One (General Provisions – Articles 1 to 3);
- Chapter Two (Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc. – Articles 4 to 64);
- Chapter Three (Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc., Category Medical Device Manufacturers, etc. – Articles 65 to 72);
- Chapter Four (Manufacturing Control and Quality Control in Manufacturing Sites of Biological-Origin Medical Devices, etc., Manufacturers, etc. – Articles 73 to 79); and
- Chapter Five (Manufacturing Control and Quality Control in Manufacturing Sites of In-Vitro Diagnostic Reagents Manufacturers, etc. – Article 80).
Chapter Two is broken down further into six sections:
- Section One (General Rules – Article 4);
- Section Two (Quality Management System – Articles 5 to 9);
- Section Three (Management Responsibility – Articles 10 to 20);
- Section Four (Resource Management – Articles 21 to 25);
- Section Five (Product Realization – Articles 26 to 53); and
- Section Six (Measurement, Analysis, and Improvement – Articles 54 to 64).
Now for those readers that made the connection between Articles 4 to 64 and the link to EN ISO 13485:2003, you have passed Dr. D’s first exam. For those of you that did not, the doctor suggests brushing up on the ISO standard. Remember, Chapter Two, in the eyes of PMDA, is the foundation for your organization’s QMS.
Chapters 3 through 5 of MO 169 contain secondary information that is extremely important for device manufacturers wishing to enter product into Japan. For example, labeling requirements, devices containing biologics requirements, and requirements for in-vitro diagnostic devices are delineated within these chapters. Not wanting to over simplify these salient requirements, but obliged to do so; “failure to comply equates to no Yen coming from the land of the rising sun.”
What device manufacturers need to do
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. That being said, Dr. D recommends beginning with the performance of a gap assessment between your organization’s QMS versus MHLW MO 169. The doctor also recommends creating a procedure matrix and commence with the mapping of your organization’s QMS to MO 169 (see Table 1). Additionally, when devices manufacturers are ready to submit their device applications to PMDA for review, having a QMS compliant with MO 169 is a salient requirement for certification. In fact, for a Class III or IV device, you can expect a friendly visit from PMDA at some point in time. Remember, a QMS examination is mandatory and will require and independent application.
|| 21 CFR, Part 820
|| EN ISO 13485:2003
|| MHLW MO 169
| 1234-1 Rev A
|| Internal Audits
|| Article 56
| 1235-2 Rev D
|| Management Review
|| Article 18
For this edition of DG, the doctor will leave the readers with three takeaways. One – there are significant similarities between MO 169 and EN ISO 13485:2003; and that is very good news. Two – there is a mandatory examination requirement associated with the QMS. Three – expect a visit from PMDA when applications for Class III and IV devices are made.
Until next week, when the doctor provides guidance on MO 169 – Chapter 1 “General Rules” (Articles 1 through 3), Sayonara from Dr. D and best wishes for continued professional success.
The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.
Many American-based devices companies are linguistically challenged when it comes to languages other than English, including UK version of English. However, letting your next door neighbor translate marketing material because Spanish is their native tongue is just insane.
The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.
FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.