Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Samishi katta desu” For those of you moderately fluent in Japanese, the phrase is: “さみしかったです。” The literal translation is “I miss you so much.” Chances are pretty good that device manufacturers will not be whispering this into the ears of the regulatory gods in Japan; and Dr. D highly doubts this phrase would ever come from PMDA. But hey, if the readers are not able to garner some useful regulatory or quality advice from this week’s guidance, at least you will be able to learn some Japanese.

Seihin Hyojun Sho (no the doctor is not cursing at the readers in Japanese, it refers to Device Master File) moves to the forefront of this week’s discussion. Similar to other devices being shipped into Japan, the Japanese equivalent of a technical file is required for devices containing a derivative of biological origin. Dr. D loves the consistency of MO 169 as it applies to medical devices as a common-sense approach applies across the entire spectrum of devices. Please keep in mind, as you read this week’s DG, the doctor would never “traduce” (look-it-up) the trust of his readers. The guidance provided, although delivered with some attempts at levity, reflects Dr. D’s personal interpretation of MO 169 and hopefully aligns with the perception of industry views. If not, oh well, this is the doctor’s platform to entertain weekly. On another note, for the readers visiting MD&M in Anaheim, Dr. D is planning to be in attendance. Feel free to buy the old doctor a drink if you run into me.

Ministerial Ordinance Number 169 (2004)

Chapter 4 – Manufacturing Control and Quality Control in Manufacturing Sites of Biological-origin Medical Device, etc. Manufacturers, etc.

(Documents concerned with Manufacturing Control and Quality Control)

Article 74 The biological-origin medical device, etc. manufacturer, etc. shall, in case where they manufacture the products concerned with the biological-origin medical devices, etc., for each of the products, establish Seihin Hyojun Sho describing the following items in each of the manufacturing sites.

1. The name, essence and property of the objects obtained from humans, animals, plants or microorganisms using as the constituent parts, etc. and their quantities therein, and other specifications,
2. The specifications (including the keeping control methods) of the animals utilized in the manufacturing or testing (including the donor animals, and hereinafter referred to as “utilized animals”), and
3. Other necessary items.

What device manufacturers need to know

Guidance for complying with Article 74 will be brief. Since having the Seihin Hyojun Sho is not optional, you might as well just start compiling one now. Inclusions into the Seihin Hyojun Sho to be considered are:

• Design and development information;
• Product and component drawings and specifications;
• Manufacturing processes and procedures (do not forget the flow charts);
• Labeling information;
• Packaging information;
• Test and inspection methods;
• The identification and properties of all medical devices manufactured or testing performed that contain a component consisting of human, animal, botanical (plant), or microorganism origin;
• Specifications and controls applied for medical devices  manufactured or testing performed that contain a component consisting of human, animal, botanical (plant), or microorganism origin; and
• The home address of the Chief Impalable Officer (CIO) – just kidding.

What device manufacturers need to do

As stated in the previous section, the Seihin Hyojun Sho is not optional. The good news is that if a device manufacturer has previously assembled a European Technical File or FDA 510(k), then all of the information required to populate the Japanese version of a technical file is already available. The key is organization and structure of the Device Master File. If you address all of the elements depicted in the previous section, you should have no problems breezing through a review/inspection of the Seihin Hyojun Sho by PMDA. However, if device manufacturers fail to provide all of the supporting data in a logical and organized fashion, then the CIO may have an appointment with the “ceremonial sword.” (The doctor recommends visiting Emergo Groups’ website for additional information pertaining to the Seihin Hyojun Sho). 

As for a direct correlation with 21 CFR, Part 820 or EN ISO 13485:2012, there really isn’t one, so Table 1.0 contains generic references to document control and records control. However, Dr. D strongly recommends creating a work instruction for the compiling/creation of the Seihin Hyojun Sho. The work instruction should be similar in content to work instructions used to create and manage European Technical Files. If a work instruction doesn’t exist for Technical Files, there is no time like the present to start writing. 

Table 1.0 – Sample Requirements Matrix
Procedure(s)	Procedure Name(s)	Requirement	21 CFR, Part 820	EN ISO 13485:2012	MHLW MO 169
1241-1 Rev C 1242-1 Rev G	Document Control Records Management	Documents Concerned with Manufacturing Control & Quality Control	820.40 820.180	4.2.3 4.2.4	Article 74

For this week’s guidance, the doctor will leave the readers with just one takeaway. The Seihin Hyojun Sho is not optional so procrastination or ignorance will not placate the regulatory gods in Japan. A phrase made famous by the Nike commercials and so applicable to this week’s guidance is “Just do it!” If your organization does not have the technical expertise or resources to create the Seihin Hyojun Sho, then seek help.

Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 4 “Manufacturing Control and Quality Control in Manufacturing Sites of Biological-origin Medical Device, etc. Manufacturers, etc.” (Article 75 – Process Control), sayonara from Dr. D and best wishes for continued professional success.

References: 

1. Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
2. EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
3. Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm. 
4. 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 http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf. 
5. Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf.