Devine Guidance
MHLW MO 169 – Chapter 4 – Documents & Records

Dr. Christopher Joseph Devine, President, Devine Guidance International

Ohayou Gozaimasu. An appropriate Japanese phrase for this week’s guidance is; “Shimen soka.” For those of you moderately fluent in Japanese, the phrase is: “四 面 楚 歌” The literal translation is “Chu songs on all sides.” In plain English, the meaning is the situation is desperate beyond hope. If during a PMDA inspection, the Chief Impalable Officer (CIO) hears this phrase from the inspector, well readers, you know the drill by now. Break glass, remove ceremonial sword, and fall on sword.

The doctor is going to climb back onto his soapbox one final time for this series of article on MO 169 and talk about the importance of records. As most of you already know accurate records are extremely important when defending compliance to 21 CFR, Part 820, the FDA’s Quality System Regulation. Nobody wants to sit across from an FDA investigator, during an inspection, and have poorly documented records to defend compliance. Can you say Form 483 observation? Well, a deep subject Dr. D knows, there is no difference during PMDA inspections. PMDA expects the records of compliance to be meticulous. Remember, “idiopathic” (look-it-up) memory loss is never acceptable during an inspection, regardless of the regulatory body performing the inspection.

That being said, this week’s guidance is pretty simple to comprehend. In fact, it is a tale of two policies: (a) documents and records device manufacturers are required to retain; and (b) exceptions to the record retaining policy. Enjoy.

Ministerial Ordinance Number 169 (2004)
Chapter 4 – Manufacturing Control and Quality Control in Manufacturing Sites of Biological-origin Medical Device, etc. Manufacturers, etc.
(Control of Documents and Records)
Article 78 The biological-origin medical device, etc. manufacturers, etc. shall retain at least one copy of the documents specified in this Chapter for the following period (5 years for the documents concerned with the training) from the date of obsolescence, with the proviso that this provision shall not apply to the documents used for the manufacturing or testing of the products in case where they are maintained to be available for the retention period of the records of the products specified in next Paragraph 2.
  1. 30 years plus the shelf life of the products concerned with the specified biological-origin medical devices or the biological-origin medical devices manufactured using human blood as the origins of the biological-origin raw materials (the origins of the raw materials or materials used in the manufacturing (including those used in the manufacturing process, and hereinafter referred to as such)), or
  2. 10 years plus the shelf life for the products concerned with the biological-origin medical devices (excluding those specified in preceding Item (1)) or the cell/tissue-based medical devices (excluding those specified in preceding Item (1)).
2. The biological medical device, etc. manufacturer, etc. shall retain the records specified in this Chapter for the period specified in preceding Item (1) or (2) of preceding Paragraph 1 (5 years for the records concerned with the training) from the date of the establishment.
 
(Exceptions to Retention of Records)
Article 79 The biological-origin medical device, etc. manufacturer, etc. shall, for the products concerned with the biological-origin medical devices designated by Minister of Health, Labor and Welfare, notwithstanding the provision of this Chapter, retain the records specified in this Chapter for the period designated by Minister of Health, Labor and Welfare, with the proviso that this provision shall not apply in case where the record are maintained appropriately by the biological-origin raw material origins collectors, etc. for such period under a contract concluded between the manufacturer, etc. and such biological-origin raw material origins collectors, etc.
 
What device manufacturers need to know
Three key numbers to remember are 5, 10, and 30. No these are not the daily “Pick-3 Lotto Numbers.” These are the numbers associated with the number of years required for record retention for medical devices containing a component of biological origin. For example:
  • Training documents/records  must be retained for a period of 5-years, after their obsolescence;
  • For devices employing a component of biological origin containing a human-blood derivative, the requirement for record retention is 30-years, plus the shelf-life of the device; and
  • For devices employing a component of biological origin containing cell/tissue material, the requirement for record retention is 10-years, plus the shelf-life of the device.
Article 79 is essentially a catch-all requirement restating the fact that records must be retained to meet requirements delineated within Chapter 4 of MO 169. Manufacturers of medical devices containing a component of biological origin are duly obligated to comply with Chapter 4 requirements. MHLW defines the record-retention rules, so when in doubt of the requirement, it is strongly recommended that you contact the Japanese regulatory folks for guidance.  
What device manufacturers need to do
Dr. D sees some organizations scripting dedicated record retention procedures to comply with record-retention requirements unique to Japan. However, there is no regulatory-driven need to do so. Listen; if your organization already has a well-scripted SOP for record retention, there is no reason to write a stand-alone SOP to meet Article 78 and Article 79 requirements. Please exercise some common sense and place the requirements into an existing procedure. In fact, there is no logical reason not to include record-retention requirements for multiple regulatory requirements into on SOP. Just a quick note, as you can see from Table 1, Articles 78 and 79 can be mapped to 21 CFR, Part 820 and ISO 13485.  
 

Table 1.0 – Sample Requirements Matrix

 

 Procedure(s)

 Procedure Name(s) 

 Requirement 

 21 CFR, Part 820 

 EN ISO 13485:2012 

 MHLW MO 169

 1242-1 Rev G

 Control of Records 

 Control of Documents & Records

 820.180

 4.2.3
 4.2.4

 Article 78

 1242-1 Rev G

Control of Records  

Exceptions to Retention of Records  

 820.180 

 4.2.4

Article 79 
Takeaways
For this edition of DG, there is just one takeaway. Yes, there are some unique record-retention requirements associated with Ministerial Ordinance 169, so deal with it. Seriously, Dr. D strongly recommends employing a little bit of common sense and script just one well-written SOP for all of your organization’s needs. Trust the old doctor you will be glad that you did.

Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 5 “Manufacturing Control and Quality Control in Manufacturing Sites of In-Vitro Diagnostic Reagent Manufacturers, etc.” (Article 80 – Provisions to be Applied Mutatis Mutandis), sayonara from Dr. D and best wishes for continued professional success.

Note: there is just one more article remaining for MO 169. If you have a topic you would like to see Dr. D cover, please let me know.

References: 
  1. Code of Federal Regulation. (2012, 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. Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products
  4. Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 11, 2013, from http://www.linguanaut.com/english_japanese.htm
  5. 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
  6. 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. 

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