Devine Guidance

MHLW MO 169 – Chapter Two: General Rules

By Dr. Christopher Joseph Devine
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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!”

Ohayou Gozaimasu. This week let’s talk about rules. Although Dr. D has never been a big fan of rules, and has been known to break a few (thousand), regulations are all about rules.

Chapter 2 – Section 1 (Article 4) delineates the general rules associated with Chapter 2 of MO 169. For readers hoping for some cerebral “divertissement” (Look-it-up), the doctor will start this week’s DG off with the introduction of a new term, for some of you: Shonin. Shonin is what a used-car dealer does when he or she attempts to sell an old car to an unsuspecting buyer (LOL – just kidding).

The term Shonin is associated with the Pre-market approval process associated with Class II, III, and IV devices in Japan. In short, it is a device application, not unlike the PMA employed in the United States. There are two types of Shonin approvals possible: (a) direct-manufacturing Shonin; and (b) the Japanese-distributor Shonin. The key difference is having the Shonin in the device manufacturer’s name allows for flexibility in regards to selecting and changing distributors. If the Shonin is in the distributor’s name, the distributor is unlikely to give up control of the Shonin, if the device manufacturer wants to make a change. That being said, the best advice Dr. D can give is to choose wisely.  

Ministerial Ordinance Number 169 (2004)
Chapter Two “Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc.”
Section One – General Rules
Article 4 – The provisions of Articles 30 to 36 shall not apply to the products concerned with the medical devices other than both the specially designated medical devices specified in Paragraph 1 of Article 77-5 of Law and the medical devices designated by Minister of Health, Labour and Welfare as those of which design and development (hereinafter referred to as “design and development”) are necessary to be controlled to ensure that the manufacturing control and quality control are conducted appropriately.
2. The manufacturer, etc., in case where any provisions of Section 5 of this Chapter are not applicable to their products due to the nature of the medical devices concerned with the products, may not apply such provisions to their quality management system.
3. The manufacturer, etc. shall, in case where either of the provisions specified in preceding two Paragraphs 1 and 2 is applied to, describe the details of such application in the documents which specify the quality management system concerned with the manufacturing site (hereinafter referred to as “quality manual”).
What device manufacturers need to know
For starters, requirements for design and development activities (Articles 30 through 36) do not apply for all devices. For example, if a device company is manufacturing a cardiac ablation catheter (Class IV); they will need to comply with the design and development requirement. If the device is categorized as a Class I, the application of design and development controls is probably not a salient requirement.
Product Realization (spelled with a z versus an s) also falls into the category of not necessarily applying for all devices. However, not having to comply with the product realization associated Articles (Articles 26 to 53) is a rare event indeed. Assuming an organization is already in compliance with EN ISO 13485:2003, complying with Section 5 (product realization) of MO 169 should be a breeze.
Finally, if a device manufacturer determines that design and development and product realization are applicable, it is not enough just to generate procedures and comply. Please ensure that the applicability of these requirements is delineated within the quality manual. If your organization is in compliance with EN ISO 13485:2003, then hopefully, the quality manual already contains references to these requirements.
What device manufacturers need to do
Dr. D recommends determining if design and development and product realization requirements apply to your organization. The doctor is a gambling man, so I will bet these requirements apply. That being said, what in the heck are you waiting for, just commence with the typing already. The doctor recommends employing a matrix (reference Table 1.0 – Sample Matrix) similar to the one Dr. D posted two-weeks ago in his blog entitled MHLW Ministerial Ordinance 169. Regardless of the approach pursued, the goal is to have documented evidence of compliance. Remember, for Class III and IV devices, PMDA will eventually pay a visit to your facility for the purposes of performing and audit. For Class II devices, depending upon your notified body, the notified body will audit on behalf of PMDA (e.g., TUV-R is approved to perform audits on behalf of PMDA for Class II devices).

Name 21 CFR Part 820 
EN ISO 13485:2003  
MHLW MO 169 
1236-1 Rev A  Design & Development  820.30    7.3  Articles 30 to 36  
1237-1 Rev D  Product Realization    820.70   Articles 26 to 53  
Table 1.0 – Sample Matrix 

For this edition of DG, the doctor will leave the readers with just one takeaway. Chances are pretty good that design and development and product realization requirements are required. If your organization already has a Quality Management System 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!”

Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 2 “Quality Management System” (Articles 5 through 9), sayonara from Dr. D, and best wishes for continued professional success.


  1. Gross, A, & Hwang, T. (1995, January). Changing regulatory environment in Japan’s medical device industry opens new opportunities for American companies. Retrieved June 29, 2012, from
  2. Marketing Authorization Holder for Japan. (2012) Emergo Group website. Retrieved June 24, 2012, from
  3. Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

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