Overview of Japan Pharmaceutical Affairs Law:

Medical Devices

Jan, 2014

Japan Regulatory Service

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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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CLASSIFICATION OF BUSINESS LICENSES

Section 1.

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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. RetailersRetailers distribute a medical device shipped by MAH to a market.

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WHAT IS MAH?Section 2.

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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 MAH1. 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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Manufacture

What is MAH?

MAH General Manager of Manufacturing & Sales

Safety Control Manager

Quality Control Manager

GVP GQPSafety Control Dep. Quality Control Dep.

QMSMarket Shipment

Management, direction

Report, Opinion

Management, direction Report,

Opinion

Cooperation

MAH checks the QMS compliance.

Agreement Shipping instruction

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WHAT IS MANUFACTURER?Section 3.

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What is Manufacturer?

• ManufacturingThe manufacturer can manufacture a product under management of MAH.

• Requirements for Manufacturer1. 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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DIFFERENCES OF MAH AND MANUFACTURER

Section 4.

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Differences of MAH and Manufacturer

ManufacturerMAH Market

Hospital

Management

Product

Retailer

Distribution,Rental

Responsibility

Permission for manufacturing a product

Permission for shipping and selling a product

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ABOUT PRODUCTS MANUFACTURED AND MARKETED IN JAPAN

Section 5.

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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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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