Ministerial Ordinance 169 — QMS Ordinance
Ministerial Ordinance 169 is Japan's primary QMS standard for medical device and IVD manufacturers. Its full title is 医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令 (Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics). It is legally binding under the PMD Act.
Full title and citation
- Short title: QMS Ordinance / MO 169
- Japanese title: 医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令
- Citation: Ministerial Ordinance No. 169 of 2004, as amended (most recently revised 2021)
- Effective: Revised version in force from April 2021
Current text: e-Gov — MO 169 (search 薬事法施行規則 or 医療機器 品質管理)
Structure of MO 169
MO 169 is organised in chapters that broadly parallel ISO 13485:2016:
| Chapter | Content |
|---|---|
| Chapter 1 | General provisions — scope, definitions |
| Chapter 2 | Management responsibility |
| Chapter 3 | Resource management |
| Chapter 4 | Product realisation — design controls, purchasing, production |
| Chapter 5 | Measurement, analysis and improvement — audits, CAPA |
| Chapter 6 | MAH-specific requirements — quality oversight, GPSP interface |
Key requirements by chapter
Chapter 2 — Management responsibility: Quality policy, management review, designation of Responsible Technical Officer (in MAH context) and manufacturing manager (in manufacturer context).
Chapter 3 — Resource management: Personnel competence and training, infrastructure and work environment.
Chapter 4 — Product realisation: Planning of realisation processes; design and development controls; purchasing and supplier controls; production and service provision controls including process validation, sterilisation, and environmental controls; control of monitoring and measuring devices.
Chapter 5 — Measurement, analysis, improvement: Internal audits; monitoring and measurement of processes and products; control of nonconforming product; data analysis; CAPA.
Chapter 6 (MAH-specific): The MAH's quality oversight of contracted manufacturers; interface with GPSP surveillance obligations; Japanese labelling document control.
2021 revision — ISO 13485:2016 alignment
The 2021 revision brought MO 169 into close alignment with ISO 13485:2016 (which itself updated from the 2003 version in 2016). The main changes were:
- Addition of risk-based thinking throughout (not just in design controls)
- Strengthened requirements for software lifecycle management
- Updated requirements for post-market information feedback into the QMS
- Alignment of supplier control requirements with ISO 13485:2016
Manufacturers already compliant with ISO 13485:2016 found the transition to the revised MO 169 relatively straightforward.