MDSAP · Medium · 14 min lesson
Japan - MHLW Ministerial Ordinance 169 as amended, PMDA, the marketing authorization holder and QMS inspections
MHLW Ministerial Ordinance 169 (2021 revision), PMD Act articles 23-2-3, 68-10 and 68-11, PMDA acceptance of MDSAP reports, MDSAP Audit Approach chapters 1, 2 and 4
What you will learn
- Explain MO 169 and its 2021 alignment with ISO 13485:2016.
- Describe PMDA use of MDSAP reports.
- Handle MAH and registered manufacturing site duties.
Key takeaways
- The MAH holds the approvals and legal responsibility; manufacturing sites are registered separately for five years.
- MO 169 chapter 2 was aligned with ISO 13485:2016 in 2021, with compliance required by 25 March 2024.
- The PMDA accepts MDSAP reports as evidence, not as an exemption; Japan specific requirements still apply.
- The MAH reports adverse events to the PMDA; the maker must feed it in time under MO 169 article 69.
- Write the MAH and maker split into an agreement with time limits, retention periods and site change notice.
Free practice question
Ferrowen adds a new contract sterilizer in Europe for Japanese lots. The team plans to tell Kasumi after the first shipment.
What is the right action?
Tell Kasumi before implementation so the MAH can register the sterilizer under article 23-2-3 before devices from it are shipped.
Correct. Article 23-2-3 of the PMD Act requires sterilization sites to be registered, and MDSAP chapter 2 checks site registrations.
Tell Kasumi after the shipment, since it is only a sterilizer.
Not quite. Sterilization sites for Japan must be registered before use, so notifying after shipment is too late under the PMD Act, as MDSAP auditors expect.
Do nothing, because contract sites are exempt.
Not quite. Contract manufacturers and sterilizers are included in the site registration requirement of article 23-2-3.
Ask the distributor to register it.
Not quite. The MAH applies for site registration, not the distributor, under article 23-2-3 of the PMD Act.
Key terms
- MAH: Marketing authorization holder: the company that holds the licence and approvals in Japan and is the legal manufacturer by default (PMD Act).
- registered manufacturing site: A site doing design, main manufacture, sterilization or final release for Japan, registered by address for five years (article 23-2-3).
- MO 169: MHLW Ministerial Ordinance 169, the Japanese QMS requirements for devices and IVDs, with chapter 2 aligned to ISO 13485:2016 in 2021.
- PMDA: Pharmaceuticals and Medical Devices Agency, which reviews applications and conducts QMS inspections.
- QMS conformity certificate: Certificate that the QMS meets MO 169, issued with approval, valid five years.
- adverse event report: Report by the MAH to the PMDA under PMD Act article 68-10, in 15 or 30 days depending on seriousness and expectedness.
- retention periods: Record periods under MO 169 articles 8, 9, 67 and 68: five years, or longer if shelf life requires; fifteen years for designated devices.
Official sources
- Revision of Japanese Medical Device QMS requirements (PMDA)
- MDSAP (PMDA, QMS inspection and MDSAP reports)
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japanese Law Translation)
- Post-marketing Safety Measures of medical devices (PMDA slides)
- MDSAP AU P0002.009, MDSAP Audit Approach (FDA)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.