1. Responsibility of Marketing
Authorization Holders
-Overview of GQP and GVP-
Jan, 2014
Japan Regulatory Service

2. Contents
Section 1. Requirements for MAH (Marketing
Approval Holder)
Section 2. What is GQP?
Section 3. GQP Organization Structure
Section 4. What is GVP?
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3. Section 1.
REQUIREMENTS FOR MAH
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4. Requirements for MAH
(Marketing Approval Holder)
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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5. Section 2.
WHAT IS GQP?
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6. What is GQP?
Market
MAH
Manufacturer
Responsibility
Retailer
Product
Management
Permission for
manufacturing a
product
Permission for
guaranteeing the
quality of a
product
Distribution,
Rental
Hospital
GQP
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7. What is GQP?
• Standard for Quality Control of medical
devices
• GQP: Good Quality Practice
• MHLW Ministerial Ordinance No. 136, 2004
Standard for MAH performing quality
assurance of medical devices
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8. Section 3.
GQP ORGANIZATION
STRUCTURE
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9. GQP Organization Structure
MAH
Management,
direction
Safety Control
Manager
General Manager of
Manufacturing & Sales
Report,
Opinion
Report,
Opinion
Cooperation
Quality Control
Manager
Quality Control Dep.
Safety Control Dep.
Management,
Quality check
Market
Management,
direction
Shipment
Shipping instruction
Manufacture
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10. Section 4.
WHAT IS GVP?
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11. What is GVP?
• Standard for Safety Control after
manufacturing and selling a medical device
• GQP: Good Vigilance Practice
• MHLW Ministerial Ordinance No. 135, 2004
Standard for MAH performing safety control
of medical devices
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12. What is GVP?
Practice for GVP
1. Collection, classification, examination, and
evaluation of safety information
2. Implementation of required measures
3. Self check
4. Educational training
5. Retention of records etc.
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13. What is GVP?
Report of the adverse event/defect based on the
Pharmaceutical Affairs Law:
• Defect report, Infectious disease report
⇒within 15 or 30 days
• Measurement in abroad report
⇒within 15 days
• Research report
⇒within 30 days
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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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