This document discusses the process for foreign manufacturers to obtain accreditation from the Japanese Ministry of Health, Labour and Welfare to export medical devices to Japan. It outlines the requirements, application process, and fees for initial accreditation, changes to an existing accreditation, renewal of accreditation, and notifications of changes. The accreditation process involves submitting application documents to both the Ministry and the Pharmaceutical and Medical Devices Agency, who reviews facilities and processes to ensure compliance with Japanese regulations.

1. Accreditation of
Foreign Manufacturers
: Medical Device
Japan Regulatory Service
http://www.japan-rs.com

2. Overview of FMA
1. What is FMA?
A foreign manufacturer (a person/a company)
intending to manufacture medical devices in
foreign countries and export them to Japan, is
required to be accredited by the Minister of Health,
Labour, and Welfare as an “Accredited Foreign
Manufacturer”, specified in Article 13-3 of PAL
(Pharmaceutical Affairs Law).
This is “Foreign Manufacturers Accreditation”.
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3. Overview of FMA
1. What is FMA?
• Who is the authority?
The Minister of Health, Labour and Welfare
• Who examines ?
PMDA (Pharmaceutical and Medical Devices
Agency)
• Which accreditation category is granted?
For each manufacturing establishment
according to the category specified by the
Enforcement Regulations. (Please see Part 2.
Accreditation Category)
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4. Overview of FMA
1. What is FMA?
• How to obtain Foreign Manufacturers
Accreditation?
Application of new accreditation and Payment
of fees are required.
• How long the accreditation is effective?
The accreditation is effective for 5 years.
Accredited foreign manufacturers must renew
their accreditation every 5 years.
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5. Overview of FMA
2. Accreditation Category: Medical Device
I. Cell/Tissue Medical Devices etc.（Article 36, Paragraph 4, Item 1）
Accreditation for all or part of the manufacturing process of the medical devices
designated by the Minister pursuant to the provisions of Article 43, Paragraph 2 of PAL as
well as of the medical devices designated by the Minister as requiring due caution to be
exercised in their manufacturing control and quality control pursuant to the provisions of
Article 80, Paragraph 2, Item 3 of the Ordinance
II. Sterile Medical Devices （Article 36, Paragraph 4, Item2）
Accreditation for all or part of the manufacturing process of sterile medical devices
(excluding manufacturing processes indicated in IV)
III. General （Article 36, Paragraph 4, Item 3）
Accreditation for all or part of the manufacturing process of medical devices other than
those indicated in the preceding I and II (excluding manufacturing processes indicated in
IV)
IV. Packaging, Labeling, Storage (Article 36, Paragraph 4, item 4）
Accreditation for only the process of packaging, labeling or storage among the
manufacturing processes of medical devices indicated in the preceding II and III.
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6. Overview of FMA
3. Requirements for accreditation
Requirements for accreditation is the followings:
 Building and establishment of the facility comply with
“Regulations for Buildings and Facilities of Pharmacies,
etc.”.
 An applicant does not corresponds to the disqualification
clause.
PMDA reviews the compliance with these requirements
based on the submitted documents.
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7. How to submit application documents
1. New accreditation
I. Application form of accreditation
- Form No. 18 in the PAL Enforcement Regulations
- Addressed to the Minister of Health, Labour and Welfare
II. Audit request form of accreditation
- Form No. 16-2 in the Regulations
- Addressed to Chief Executive of PMDA
III. Fees（Document Inspection）
Examination fee: 58,100JPY
Registration license tax: 90,000 JPY
Total: 148,100 JPY
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8. How to submit application documents
1. New accreditation
IV. Required attachment documents for FMA application
a. Self-Declaration
b. Responsibility Matrix (Organization chart)
c. Personal History of Manufacturing Manager
d. Product List and Manufacturing Process List
e. Manufacturing Flow Chart
f. Facility Building Outline
g. Top Plant View
h. Floor Plan of Manufacturing Site
i. Copy of the Marketing License/Manufacturer License
that were issued by the government of the country or
ISO 13485 Certificate
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9. How to submit application documents
2. Addition/Change in Accreditation Category
I. Application form of Addition/Change in accreditation category
- Form No. 21 in the PAL Enforcement Regulations
- Addressed to the Minister of Health, Labour and Welfare
II. Audit request form of accreditation
- Form No. 16-2 in the Regulations
- Addressed to Chief Executive of PMDA
III. Fees（Document Inspection）
– Addition of accreditation category
Examination fee: 39,700JPY
Registration license tax: 90,000 JPY
Total: 129,700 JPY
– Change of accreditation category
Examination fee: 39,700JPY
Registration license tax: 23,400 JPY
Total: 59,100 JPY
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10. How to submit application documents
2. Addition/Change in Accreditation Category
IV. Required attachment documents for Addition/Change in
accreditation category application
a. Foreign Manufacturers Accreditation Certificate
b. Product List and Manufacturing Process List that
relates to change or addition in category of
accreditation
c. Documents on Buildings and establishment of the
facility that relates to change or addition in
category of accreditation
d. Manufacturing flow chart (If needed)
e. Top Plant View (If needed)
f. Floor Plan of Manufacturing Site (If needed)
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11. How to Submit Application documents
3. Renewal of Accreditation
I. Application form of renewal of accreditation category
- Form No. 20 in the PAL Enforcement Regulations
- Addressed to the Minister of Health, Labour and Welfare
II. Audit request form of accreditation
- Form No. 16-2 in the Regulations
- Addressed to Chief Executive of PMDA
III. Fees（Document Inspection）
Examination fee: 23,400JPY
Registration license tax: 39,700 JPY
Total: 59,100 JPY
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12. How to Submit Application documents
3. Renewal of Accreditation
IV. Required attachment documents for Addition/Change in
accreditation category application
a. Foreign Manufacturers Accreditation Certificate
(Original)
b. Facility Building Outline
c. Top Plant View
d. Floor Plan of Manufacturing Site
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13. How to Submit Application documents
4. Notification on Change
I. Form of Notification on Change
- Form No. 6 in the PAL Enforcement Regulations
- Addressed to the Minister of Health, Labour and
Welfare
II. No Fees
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14. Additional Resources
Japan RS Additional Resources:
http://www.japan-rs.com/resource-e.shtml
Japan RS Accreditation Support Services:
http://www.japan-rs.com/accreditation-e.shtml
List of Japanese regulatory requirements:
http://www.japan-rs.com/notifications-e.shtml
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http://www.japan-rs.com/index-e.shtml
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