1. Overview of Japan
Pharmaceutical Affairs Law:
Medical Devices
Jan, 2014
Japan Regulatory Service

2. Contents
Section 1. Classification of Business Licenses
Section 2. What is MAH
Section 3. What is Manufacturer?
Section 4. Differences of MAH and Manufacturer
Section 5. About products manufactured and
marketed in Japan
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3. Section 1.
CLASSIFICATION OF
BUSINESS LICENSES
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4. Classification of Business Licenses
1. MAH (Marketing Approval Holder)
MAH decides to ship a medical device to a market. MAH
makes a manufacturer manufacture a product and they
manage it.
2. Manufacturers (In Japan/Abroad)
Manufacturers manufacture a medical device based on
MAH's instruction.
3. Retailers
Retailers distribute a medical device shipped by MAH
to a market.
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5. Section 2.
WHAT IS MAH?
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6. What is MAH?
• Manufacturing and sales (PAL: Art. 2)
MAH can market, lease and/ or grant medical devices which
manufactured or imported. They can not manufacture the
product themselves.
• Requirements for MAH
1. An applicant does not correspond to disqualification
matters.
2. The quality control system is suitable.= GQP
3. The safety control system after manufacturing and
selling is suitable. = GVP
4. General manager for manufacturing and sales is
installed.
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7. What is MAH?
General Manager of
Manufacturing & Sales
MAH
Management,
direction
Report,
Opinion
Safety Control
Manager
Management,
direction
Report,
Opinion
Cooperation
Quality Control
Manager
GVP
GQP
Safety Control Dep.
Quality Control Dep.
MAH checks the
QMS compliance.
Market
Shipment
Agreement
Shipping instruction
Manufacture
QMS
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8. Section 3.
WHAT IS MANUFACTURER?
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9. What is Manufacturer?
• Manufacturing
The manufacturer can manufacture a product under
management of MAH.
• Requirements for Manufacturer
1. Compliance to “Regulations for Buildings and
Facilities of Pharmacies”
2. Responsible technical manager is installed.
A manufacturer can not ship a product by their judgment.
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10. Section 4.
DIFFERENCES OF MAH AND
MANUFACTURER
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11. Differences of MAH and Manufacturer
Market
MAH
Manufacturer
Responsibility
Retailer
Product
Management
Permission for
manufacturing a
product
Permission for
shipping and
selling a product
Distribution,
Rental
Hospital
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12. Section 5.
ABOUT PRODUCTS
MANUFACTURED AND
MARKETED IN JAPAN
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13. About products manufactured and
marketed in Japan
-Application Procedure for Medical Device• Highly control medical device, Control medical device
⇒ Approval application + QMS conformity application
• Designated control medical device
⇒ Certification application + QMS conformity application
• General medical device
⇒ Submission of Manufacturing and sales notification
If needed, a submission of “Import declaration”, “Export
declaration”, or “Foreign manufacturer accreditation” is
required.
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14. Thank you for your time!
If you have any questions, we encourage you to contact us. Our contact
information is on our website. There is a lot of information on the website, so I
encourage you to take a look at: http://www.japan-rs.com. So, again, I
encourage you to send us any questions or comments that you have on
Japanese regulatory rule.
Thank you for your time.
Japan RS’s additional Learning Resources:
http://www.japan-rs.com/resources-e.shtml
Regulatory process in Japan:
http://www.japan-rs.com/2013-regulatory-process.shtml
Updated regulatory information for Medical Device:
http://www.japan-rs.com
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