Devine Guidance

MHLW MO 169 – Chapter 3 – Control of Documents & Records

By Dr. Christopher Joseph Devine
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If documents and records do not exist, are illegible, or lack accuracy and detail, then all bets are off when dealing with the regulatory gods in Japan.

Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Kaite kudasai” For those of you moderately fluent in Japanese, the phrase is: “書いてください。” The literal translation is “Write it down, please.”

Do you know why Dr. D wanted to share this phrase with the readers? If you answered; “If it’s not in writing, it never happened” you would be correct. Regardless of regulatory environment, documentation and the retention of records is everything. Remember, the Chief Impalable Officer (CIO) “attestation” (look-it-up) to the accuracy of documents and records is considered a fundamental requirement during inspections. If documents and records do not exist, are illegible, or lack accuracy and detail, then all bets are off when dealing with the regulatory gods in Japan; or anywhere else for that matter. 

Ministerial Ordinance Number 169 (2004)
Chapter 3 Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. – Category Medical Device Manufacturers, etc.
(Control of Documents and Records)
Article 72 The labeling, etc. – category medical device manufacturer, 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. 15 years for the products concerned with the specially designated maintenance-control-required medical devices (1 year plus the shelf life, for the products concerned with the medical devices of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 15 years), or
  2. 5 years for the products concerned with the medical devices other than the specially designated maintenance-control-required medical devices (1 year plus the shelf life, for the products of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years).
2. The labeling, etc. – category medical device manufacturer, etc. shall retain the records specified in this Chapter for the following period (5 years for the records concerned with the training) from the date of the establishment.
  1. 15 years for the products concerned with the specially designated maintenance-control-required medical devices (1 year plus the shelf life, for the products concerned with the medical devices of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 15 years), or
  2. 5 years for the products concerned with the medical devices other than the specially designated maintenance-control-required medical devices (1 year plus the shelf life, for the products concerned with the medical devices of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years).
What device manufacturers need to know
Can you say record retention? The doctor would hate to have my readers suffer from RRDD a.k.a., Record Retention Deficiency Disorder. Although not fatal, unless the CIO is forced to fall on a sword, RRDD has the potential to inflict serious pain for the unassuming medical device manufacturer. The cure can be quite painful if the prescription to cure RRDD is coming directly from PMDA. Ouch!
Seriously, Ministerial Ordinance 169 (MO 169) has specific requirements relating to periods for data retention. The key time-periods device manufacturers need to comprehend are:
  • Five years for documents relating to training;
  • For specially designated maintenance-control-required medical devices, the retention period is 15 years; and
  • Five years for devices not categorized as specially designated maintenance-control-required medical devices.
Simply stated, 5/15/5 is the basic requirement for record retention to meet the requirements called out within Article 72.
What device manufacturers need to do
The best advice Dr. D can offer is to ensure your organization scripts a well-written procedure delineating all record retention requirements. It is considered best practice to incorporate all of the retention periods, regardless of regulatory body into one succinct document. For example, MO 169, the MDD, the QSR, etc. each have basic requirements for record retention. Instead of scripting a stand-alone procedure for each record-retention requirement, including record and document retention associated with the QMS, try putting them altogether into one document. Guess what? Pursuing this approach to documenting record retention requirements, by placing all of the retention periods into one procedure, works pretty nice. Dr. D likes it, the notified bodies like it, the FDA likes it, and PMDA likes it. Everybody likes it, so what’s the problem?
For those of you continuing to map MO 169 requirements to the QSR and EN ISO 13485:2012, Table 1.0 reflects the link between Article 72 versus QSR and ISO. In the very last article in this series, the capstone, the doctor will provide an all-inclusive requirements matrix for all MO 169 Articles versus the QSR and ISO.

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

Control of Records  

Control of Documents & Records 

820.40

820.180  

4.2.3

4.2.4 

Article 72

Takeaways
For this edition of DG, the doctor will leave the readers with just one takeaway. Simply stated, best practice is to establish one succinct document for record retention that contains sufficient granularity to address all record retention requirements, regardless of regulatory body.  Dr. D would hate to see the readers suffer through the painful affliction of RRDD or seeing the CIO impaled; however, record retention (in accordance with Article 72) is a salient requirement. Remember, 5/15/5 is the key to understanding the record retention requirement.

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 73 – Infrastructure of Manufacturing Sites of Manufacturers, etc. of Specified Biological-origin Medical Devices, etc.), 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

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

Comments

  1. Raul

    Hi Dr. Christopher,
    Appreciate your value information. Regarding “specially designated maintenance-control-required medical devices” , could you provide examples of those medical devices?
    Thanks in advance and best wishes

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