PMD Act / MHLW Ministerial Ordinance No. 169
Japanese Medical Devices Regulatory Requirements
Who it’s for
Who should attend
Regulatory affairs staff preparing Japanese registrations, MAH and DMAH personnel, quality managers responsible for MO 169 conformity and QMS conformity investigations, and manufacturers entering Japan.
Curriculum
Course modules
- MHLW, PMDA, Registered Certification Bodies and the PMD Act
- Classification Classes I to IV and JMDN codes
- Marketing Authorisation Holder and Designated MAH roles
- Foreign manufacturer registration
- The three registration routes: Todokede (notification), Ninsho (certification via RCB), Shonin (approval via PMDA)
- MHLW Ministerial Ordinance No. 169, structure, harmonisation with ISO 13485:2016, and the national requirements in Chapter 3
- QMS conformity investigation and its timing relative to product registration
- Acceptance of MDSAP certificates in place of on-site assessment
- GVP: Ministerial Ordinance No. 135
- Labelling and package insert requirements
- Adverse event reporting and post-market obligations
- The May 2025 PMD Act revision: Safety Manager, Quality Manager and Supply System Manager roles, with implementation expected by May 2027
Outcomes
What you’ll be able to do
- Select the correct Japanese registration route for a device
- Identify the gaps between an ISO 13485 system and MO 169
- Understand MAH/DMAH obligations for a foreign manufacturer
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Japanese Medical Devices Regulatory Requirements”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.