Disclaimer: This document is a machine translation and the Japan Cosmetic
Industry Association will not be liable for any damages caused by thistranslation.

Ordinance of the Ministry of Health, Labour and Welfare No. 135 of 2004
Ministerial Ordinance on Standards for Post-Marketing Safety Managementof Pharmaceuticals, Quasi-Drugs, Cosmetics, Medical Devices andRegenerative Medicine Products
Pursuant to Article 12-2, item (ii) of the Pharmaceutical Affairs Act (Act No. 145
of 1960), the Ministerial Ordinance on Standards for Post-Marketing Safety
Management of Pharmaceuticals, Quasi-Drugs, Cosmetics and Medical Devices isestablished as follows
Table of Contents
Chapter I General Provisions (Articles 1 - 2)
Chapter II Post-Marketing Safety Management Standards for Class I Manufacturers
and Distributors (Articles 3 to 12)
Chapter III Post-Marketing Safety Management Standards for Class II Manufacturers
and Distributors (Articles 13 to 14)
Chapter IV Post-Marketing Safety Management Standards for Class III
Manufacturers and Distributors (Article 15)
Chapter V Miscellaneous Provisions (Article 16)
supplementary provisions
Chapter I General Provisions(Purpose)
Article 1 This Ministerial Ordinance shall apply mutatis mutandis to the provisions of
the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical
Devices, etc. (Act No. 145 of 1960, hereinafter referred to as the "Act"). Hereinafterreferred to as the "Act"). Article 12-2, paragraph (1), item (ii), Article 23-2-2,
paragraph (1), item (ii), and Article 23-21, paragraph (1), item (ii) (hereinafter referred
to as "post-marketing safety management") Article 23-2-2, paragraph (1), item (ii)and Article 23-21, paragraph (1), item (ii) (hereinafter referred to as "post-marketing
safety management") shall be established by an Ordinance of the Ministry of Health,Labour and Welfare.

(Definition)
Article 2 The term "safety management information" as used in this Ministerial
Ordinance means information concerning the quality, efficacy and safety ofpharmaceutical products, quasi-drugs, cosmetics, medical devices or regenerative
medical products (hereinafter referred to as "pharmaceutical products, etc.") andother information necessary for the proper use of pharmaceutical products, etc.
Article 2 The term "safety management information" as used in this Ministerial
Ordinance means matters concerning the quality, efficacy and safety ofpharmaceutical products, quasi-drugs, cosmetics, medical devices or regenerative
medical products (hereinafter referred to as "drugs, etc.") and other informationnecessary for the proper use of drugs, etc.
2 The term "safety assurance operations" as used in this Ministerial Ordinance means
operations related to the collection and examination of safety management
information and necessary measures based on the results thereof (hereinafterreferred to as "safety assurance measures"), among operations related to postmarketing safety management.
3 The term "drug risk management" as used in this Ministerial Ordinance shall mean,
among the safety assurance operations, the management of the risks associatedwith pharmaceutical products (excluding in vitro diagnostic products). The same shallapply hereinafter). 3. The term "drug risk management" as used in this Ministerial
Ordinance means, among the services for ensuring safety, the services for ensuringsafety of a pharmaceutical product (excluding in vitro diagnostic products; the same
shall apply hereinafter) by a manufacturer and distributor of a pharmaceuticalproduct (excluding in vitro diagnostic products) that has matters to be specificallyconsidered concerning its safety and efficacy, by collecting information, conducting
surveys, testing and other activities to minimize risks associated with the use of thepharmaceutical product, and evaluating and taking necessary measures based on the
results thereof. (2) The term "drug product" means a drug product for whichappropriate risk management pertaining to the safety and efficacy of said drug
product is conducted by taking measures, and which is attached as a condition toapproval under Article 14, paragraph (1) or Article 19-2, paragraph (1) of the Act,
pursuant to the provisions of Article 79, paragraph (1) of the Act.

4 The term "risk management of medical devices, etc." as used in this Ministerial
Ordinance means, as part of safety assurance activities, activities by a manufacturer
and seller of a medical device or in vitro diagnostic drug, with respect to a medical
device or in vitro diagnostic drug that has particular safety and efficacy issues to beconsidered, to collect information, conduct surveys and tests related to the safety
and efficacy of the medical device or in vitro diagnostic drug, and conduct otheractivities to minimize risks associated with the use of the medical device or in vitro
diagnostic drug, as well as to evaluate the results of such activities and takenecessary measures based on such evaluation. (2) The manufacturer or distributor
shall implement appropriate risk management concerning the safety and efficacy ofthe medical device or in vitro diagnostic product by conducting activities to minimizerisks associated with the use of the medical device or in vitro diagnostic product,
and by conducting evaluations based on the results of such activities and taking
necessary measures based on such evaluations. Article 23-2-5, paragraph (12) ofthe Act (including the cases where it is applied mutatis mutandis pursuant to Article
23-2-17, paragraph (5) of the Act) (iii) "Approval" means an approval which is
attached as a condition to the approval pursuant to the provision of Article 23-2-5,
paragraph (1) or Article 23-2-17, paragraph (1) of the Act pursuant to the provisionof Article 23-2-5, paragraph (1) or Article 23-2-17, paragraph (1) of the Act or
Article 79, paragraph (1) of the Act.
5 The term "person in charge of drug information" as used in this Ministerial
Ordinance means a person whose main duty is to collect and provide safety
management information by visiting medical personnel, etc. in order to contribute to
the proper use of pharmaceutical products.
6 The term "person in charge of information on medical devices, etc." as used in this
Ministerial Ordinance means a person whose main duty is to collect and provide
safety management information by visiting medical personnel, etc. in order tocontribute to the proper use of medical devices or in vitro diagnostic products.
7 The term "person in charge of information on regenerative medical products" as
used in this Ministerial Ordinance means a person whose main duty is to collect andprovide safety management information by visiting medical personnel, etc. in order tocontribute to the proper use of regenerative medical products.

8 The term "Class I Manufacturer and Distributor" as used in this Ministerial
Ordinance means a manufacturer and distributor of pharmaceutical products
designated by the Minister of Health, Labour and Welfare as prescribed in Article 49,
paragraph (1) of the Act (hereinafter referred to as "prescription pharmaceuticalproducts"). (2) The term "manufacturer and distributor" as used in this Ministerial
Ordinance means a manufacturer and distributor of pharmaceutical products(hereinafter referred to as "prescription pharmaceutical products"), highly controlled
medical devices or regenerative medical products as prescribed in Article 49,
paragraph (1) of the Act.
9 The term "Class II manufacturer and distributor" as used in this Ministerial
Ordinance means a manufacturer and distributor of pharmaceutical products,
controlled medical devices or in vitro diagnostic products other than prescription
pharmaceutical products.
10 The term "Class III manufacturer and seller" as used in this Ministerial Ordinancemeans a manufacturer and seller of quasi-drugs, cosmetics, or general medical
devices.
Chapter II Post-Marketing Safety Management Standards for Class I
Manufacturers and Distributors(Duties of the Chief Manufacturing and Marketing Officer)
Article 3 A Class I manufacturing and marketing business operator shall perform theduties listed in the following items in accordance with the provisions of Article 17,
paragraph (2) of the Act, Article 23-2-14, paragraph (2) of the Act, or Article 23-34,
paragraph (2) of the Act (hereinafter collectively referred to as a "Chief Marketing
Authorization Holder") (2) The same shall apply hereinafter.
(i) Supervise the person responsible for safety management prescribed in paragraph(2) of the following Article.
(ii) Respect the opinion of the person responsible for safety management set forth in
the preceding item.
(iii) A person responsible for safety management set forth in item (i) and a person
responsible for quality assurance, etc. (meaning a person responsible for qualityassurance prescribed in Article 4, paragraph (3) (including the cases where it isapplied mutatis mutandis pursuant to Article 21 of the Ministerial OrdinanceConcerning Standards for Quality Management of Pharmaceuticals, Quasi-drugs,
Cosmetics and Regenerative Medicine Products (Ministerial Ordinance of the
Ministry of Health, Labour and Welfare No. 136 of 2004)) and Article 17, paragraph(3) (including the cases where it is applied mutatis mutandis pursuant to Article 21of the same Ordinance) (iii) A person responsible for quality assurance prescribed in
Article 4, paragraph 3 (including the cases where it is applied mutatis mutandis
pursuant to Article 21 of the same Ordinance) and Article 17 of the Ministerial
Ordinance Concerning Standards for Manufacturing Control and Quality Control of
Medical Devices and In Vitro Diagnostic Drugs (Ministerial Ordinance No. 169 of the
Ministry of Health, Labour and Welfare of 2004), and (2) The term "domestic quality
business operation manager" means a person in charge of domestic quality business
operation prescribed in Article 72, paragraph 1 (including the cases where it isapplied mutatis mutandis pursuant to Article 72-3, paragraph 3 of the same
Ordinance). The same shall apply hereinafter). (iii) to promote close coordination
with other persons responsible for operations pertaining to the manufacture and saleof prescription drugs, highly controlled medical devices, or regenerative medical
products.
(iv) Where a Class I Marketing Authority conducts pharmaceuticals risk management
or medical devices risk management (hereinafter referred to as "pharmaceuticals
risk management") (iii) Where a Class I manufacturing and marketing distributor
conducts pharmaceutical risk management or medical device risk management(hereinafter referred to as "pharmaceutical risk management"), a person responsible
for post-marketing surveillance, etc. (as prescribed in Article 4, paragraph (1) of the
Ministerial Ordinance Concerning Standards for Implementation of Post-Marketing
Surveillance and Testing of Pharmaceuticals (Ministerial Ordinance of the Ministry of
Health, Labour and Welfare No. 171 of 2004) or Article 4, paragraph (1) of the (Aperson responsible for post-marketing surveillance, etc. as prescribed in Article 4,paragraph (1) of the Ministerial Ordinance Concerning Standards for Implementationof Post-Marketing Surveillance and Testing of Medical Devices (Ministerial
Ordinance of the Ministry of Health, Labour and Welfare No. 171 of 2004)(hereinafter the same shall apply) (The same shall apply hereinafter.) (iii) to ensure
close mutual coordination with the person in charge of post-marketing surveillance,
etc. (hereinafter the same shall apply).

(Organization and staff related to safety assurance operations)
Article 4 A Class I manufacturing and marketing business operator shall establish adepartment (hereinafter in this Chapter referred to as the "Safety Management
Control Department") pertaining to the control of safety assurance operations thatsatisfies the following requirements Article 4 A Class I manufacturing and marketingbusiness operator shall establish a department (hereinafter in this chapter referred
to as the "Safety Management Control Department") pertaining to the control ofsafety assurance operations that meets the following requirements(i) Under the supervision of a general manufacturing and marketing manager.
(ii) Have sufficient personnel who are capable of performing safety assurance
work (excluding work to be performed by persons other than the person in charge ofsafety management pursuant to the provision of paragraph (4)) in a proper andsmooth manner. (iii) The applicant shall have sufficient number of personnel who arecapable of properly and smoothly performing safety assurance work (excluding work
to be performed by a person other than a safety manager pursuant to paragraph (4)).
(iii) independent from divisions related to the sale of pharmaceutical products andother divisions that may hinder the proper and smooth performance of safetyassurance operations; and2 A Class I manufacturing and marketing business operator must appoint a person in
charge of safety assurance operations (hereinafter in this Chapter referred to as a"safety management representative") who satisfies the following requirements (i) A
person in charge of safety management who satisfies the following requirements(hereinafter in this chapter referred to as "Safety Management Manager")(i) The person in charge of the Safety Management Control Division.
(ii) A person who has been engaged in safety assurance work or other similar work forat least three years.
(iii) The applicant must have the ability to properly and smoothly perform the safetyassurance services.
(iv) the person is not a member of a department pertaining to the sale ofpharmaceuticals, etc., and is not otherwise likely to hinder the proper and smooth
performance of the services for ensuring safety.
(3) Except in the cases prescribed in the following paragraph, a Class I manufacturingand marketing business operator must have a person responsible for safety
management perform safety assurance duties.
4 A Class I manufacturing and marketing business operator shall perform safetyassurance operations, which are defined in the Ordinance for Enforcement of the Act
on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices, etc.
(Ordinance of the Ministry of Health and Welfare No. 1 of 1961, hereinafter referred
to as the "Ordinance"). (hereinafter referred to as the "Regulations"). (2) In the caseof having a person other than a person responsible for safety management perform allor part of the tasks listed in each item of Article 97, each item of Article 114-59, oreach item of Article 137-59, a person responsible for implementation of said tasks(hereinafter referred to as "person responsible for safety management
implementation") who is capable of performing said tasks appropriately and smoothly
shall be appointed.

(Post-marketing safety management operational procedures, etc.)
Article 5 A Class I manufacturing and marketing business operator shall prepare a
post-manufacturing and marketing safety management operational procedure
document that describes the following procedures in order to properly and smoothly
conduct post-manufacturing and marketing safety management.
(i) Procedures for collecting safety management information(ii) Procedures for reviewing safety management information and formulating safetyassurance measures based on the results of such review(iii) Procedures for implementation of safety assurance measures(iv) Procedures for reporting from the Safety Management Manager to the General
Manufacturing and Marketing Manager(v) Procedures for reporting from the Safety Management Implementation Manager tothe Safety Management Manager(vi) In the case where a Class I manufacturer or distributor conducts risk
management of pharmaceuticals, etc., procedures concerning risk management ofpharmaceuticals, etc. (in the case where a drug risk management plan as prescribedin Article 9-2(1)(i) is based on a drug risk management plan as prescribed in Article
10(1), including procedures concerning said immediate post-marketing surveillance)(vii) in the case where a Class I manufacturing and marketing agent conducts a postmarketing surveillance prescribed in Article 10, paragraph (1) as applied mutatis
mutandis pursuant to Article 10-2, the procedure concerning the post-marketingsurveillance(viii) Procedures for self-inspection

(ix) Procedures for education and training for persons engaged in operations related topost-marketing safety management(x) Procedures for the preservation of records pertaining to operations related topost-marketing safety management(xi) Procedures for mutual coordination with quality assurance managers, etc. andother persons responsible for operations pertaining to the manufacture and sale ofprescription drugs, highly controlled medical devices, or regenerative medical
products(xii) In cases where a Class I manufacturer/distributor conducts risk management ofpharmaceutical products, procedures for mutual coordination with the person
responsible for post-marketing surveillance, etc.
(xiii) Other procedures necessary to properly and smoothly conduct operations
related to post-marketing safety management
2 A Class I manufacturing and marketing distributor must appropriately establish inwriting the responsibilities and management system of persons engaged in work
related to post-marketing safety management.
(3) A Class I manufacturing and marketing distributor must have a person responsible
for general manufacturing and marketing or a person responsible for safety
management establish in writing the matters necessary for proper and smooth
implementation of safety ensuring operations.
(4) When a Class I manufacturer/distributor has prepared or revised the procedure
manual referred to in paragraph (1) or the document referred to in paragraph (2),he/she shall record the date in said procedure manual or document and preserve it.
(5) A Class I manufacturer or distributor shall, when the person in charge of generalmanufacturing and marketing or the person in charge of safety management
prepares or revises the document set forth in Paragraph 3, have the date recordedon said document and have it preserved.
(6) A Class I manufacturing and marketing distributor shall have the procedure manuals
set forth in Paragraph 1, documents set forth in Paragraphs 2 and 3, documents
concerning the safety of prescription drugs, highly controlled medical devices, orregenerative medical products handled by the marketing manager, and otherdocuments necessary for safety assurance operations (hereinafter in this chapter
referred to as "post-marketing safety management procedure manuals, etc.") at theoffice where the marketing manager performs his/her duties. (hereinafter in thischapter referred to as "post-marketing safety management procedure manuals, etc.").

(Duties of the Safety Manager)
Article 6 A Class I manufacturing and marketing business operator shall have a person
responsible for safety management perform the following duties in accordance with
the Post-Marketing Safety Management Operational Procedures, etc.
(i) Supervise safety assurance operations.
(ii) Confirm that safety assurance operations are being performed properly andsmoothly, and prepare and preserve records of such operations.
(iii) When it is deemed necessary for safety assurance operations, to state its opinionsin writing to the Chief Marketing Authority and retain a copy of such opinion.
(iv) When a Class I manufacturer/distributor conducts risk management ofpharmaceutical products, etc., it shall cooperate closely with the person responsible
for post-marketing surveillance, etc. so that said risk management of pharmaceuticalproducts, etc. is conducted appropriately.
(Collection of safety management information)
Article 7 A Class I manufacturing and marketing business operator shall have a person
responsible for safety management or a person responsible for safety management
implementation collect the following safety management information in accordancewith the Post-Marketing Safety Management Operational Procedures, etc. and havethe person responsible for safety management prepare records thereof.
(i) Information from medical professionals(ii) Information on conference reports, literature reports, and other research reports(iii) Information from the Ministry of Health, Labour and Welfare and other government
agencies, prefectures and the Pharmaceuticals and Medical Devices Agency(iv) Information from foreign governments, foreign corporations, etc.
(v) Information from other manufacturers and distributors, etc.
(vi) Other safety management information(2) When having the Safety Management Implementation Manager perform the duties
prescribed in the preceding paragraph, the Class I Manufacturer/Distributor musthave the Safety Management Implementation Manager report the records of thepreceding paragraph to the Safety Management Manager in writing.
(3) A Class I manufacturer or distributor must have the safety manager retain therecords collected or reported pursuant to the preceding two paragraphs.

(Examination of safety management information and planning of measures
to ensure safety based on the results of such examination)
Article 8 A Class I manufacturing and marketing business operator must have a person
responsible for safety management perform the following duties in accordance with
the Post-Marketing Safety Management Operational Procedures, etc.
(i) review without delay the safety management information collected pursuant to thepreceding Article and Article 10, and record the results of such review(ii) In cases where the safety management information set forth in the preceding item
is deemed necessary to be understood by the Quality Assurance Manager, etc., thesafety management information shall be provided in writing to the Quality AssuranceManager, etc. without delay.
(iii) if it is found necessary as a result of the review under item (i), to formulate safetyassurance measures such as discarding, recalling, suspending sales, changing theattached documents or information on precautions, etc., providing information to
medical personnel by a person in charge of drug information, a person in charge of
information on medical devices, etc. or a person in charge of information on
regenerative medicine products, or reporting to the Minister of Health, Labor andWelfare under the Act; and (2) Planning of safety assurance measures(iv) Report in writing to the Chief Marketing Authorities on the proposed safetyassurance measures (hereinafter referred to as "proposed safety assurance
measures" in this chapter) developed pursuant to the provisions of the preceding
item, and keep a copy of the report. (iv) Report in writing to the Chief Marketing
Authority on the proposed safety assurance measures (hereinafter referred to as"proposed safety assurance measures" in this chapter) developed pursuant to thepreceding item, and retain a copy of the report.
(2) In cases where a Class I manufacturer or distributor has its Safety Management
Implementation Manager perform the analysis necessary for the examination set
forth in item (i) of the preceding paragraph in accordance with the Post-Marketing
Safety Management Operational Procedures, etc., the Class I manufacturer or
distributor must have its Safety Management Implementation Manager perform thefollowing tasks.
(i) Instruct the person responsible for safety management implementation in writing
and retain a copy of the instructions.

(ii) Have the person in charge of safety management implementation prepare therecords, report them in writing to the person in charge of safety management, andpreserve them.
(Implementation of safety assurance measures)
Article 9 A Class I manufacturing and marketing business operator must have ageneral manufacturing and marketing manager perform the following duties inaccordance with the Post-Marketing Safety Management Operational Procedures,
etc.
(i) Properly evaluate proposed safety assurance measures, determine safetyassurance measures, and prepare and preserve records of these measures.
(ii) When having the person in charge of safety management implement the safetyassurance measures, give written instructions on the implementation of themeasures and have the instructions preserved.
(iii) When having the person in charge of safety management implementation takesafety assurance measures, to instruct the person in writing on the implementationof the measures and to have the person in charge of safety management retain acopy of the instructions.
(iv) When having the person in charge of safety management implementation takesafety assurance measures, have said person in charge of safety management
implementation prepare a record of such measures, report it in writing, and have a
copy of the record delivered to the person in charge of safety management
implementation.
(v) Confirming the report pursuant to the preceding item and item (iv) of the following
paragraph, and deciding on necessary measures.
2 A Class I manufacturing and marketing business operator must have a person
responsible for safety management perform the following duties in accordance with
the Post-Marketing Safety Management Operational Procedures, etc.
(i) take safety assurance measures based on the instructions of the marketing
authorization holder as prescribed in the preceding paragraph, and prepare andpreserve records of such measures; and(ii) In the case of having the person responsible for safety management
implementation take safety assurance measures, instructions for implementation
shall be given in writing and a copy of the instructions shall be retained.

(iii) When having the person in charge of safety management implementation takesafety assurance measures, have said person in charge of safety management
implementation prepare a record of such measures, report it in writing, and preserveit.
(iv) Report the results of the implementation of safety assurance measures, etc., inwriting to the Chief Marketing Authority, and retain a copy of the report.
(v) preserve a copy of item (iv) of the preceding paragraph.
(3) A Class I manufacturer and seller may have a safety manager perform the duties
prescribed in paragraph (1) item (i) with regard to proposed safety assurance
measures that are specified in advance in the Operational Procedures for PostMarketing Safety Management, etc. in place of a general manufacturing andmarketing manager. In this case, the necessary matters for the duties prescribed in
the preceding two paragraphs shall be specified in advance in the Post-Marketing
Safety Management Operational Procedures, etc.
(Drug Risk Management)
Article 9-2 A manufacturer and distributor of a prescription drug shall, when
conducting drug risk management, have a general manufacturing and marketing
manager or a safety manager perform the following duties(i) For each drug risk management it conducts, a written plan (hereinafter referred toas a "drug risk management plan") that describes the following matters (i) A written
plan (hereinafter referred to as the "Pharmaceutical Risk Management Plan") shallbe prepared for each pharmaceutical risk management to be conducted.
(a) Matters to be particularly considered with respect to the safety and efficacy ofpharmaceutical products(b) A summary of information collection, investigations or tests on the safety andefficacy of a pharmaceutical product (including a summary of the information that amanufacturer and seller of a prescription pharmaceutical product has obtained from a
post-marketing surveillance, etc. (meaning post-marketing surveillance, etc.
prescribed in Article 2, paragraph 1 of the Ministerial Ordinance on Standards for the
Implementation of Post-Marketing Surveillance and Testing of Pharmaceutical
Products; the same shall apply hereinafter in this paragraph b). The same shall apply
hereinafter in this paragraph (b)).

(c) Outline of activities to minimize risks associated with the use of pharmaceuticalproducts(d) Status of implementation and timing of evaluation of pharmaceutical risk
management(e) Other necessary matters(ii) revise the drug risk management plan when it is deemed necessary for the
implementation of drug risk management.
(iii) When a drug risk management plan is prepared or revised in accordance with thepreceding item, the date of the revision shall be noted in the drug risk management
plan and the plan shall be preserved.
(2) A manufacturer and distributor of a prescription drug shall keep a copy of the drug
risk management plan at the office where the chief marketing authorization holder
performs his/her duties and shall keep a copy of the items described in the drug risk
management plan pertaining to the items for which he/she is responsible at otheroffices where drug risk management is performed. (2) The office shall not be
responsible for the following(3) The manufacturer and seller of a prescription drug shall, in accordance with the
Post-Marketing Safety Management Operational Procedures, etc. and the Drug Risk
Management Plan, have the person responsible for safety management conduct drug
risk management (excluding the conduct of investigations and tests pertaining to thesafety and efficacy of the drug). (3) A manufacturer and distributor of a prescription
drug shall have the safety management representative perform the following duties
in addition to the duties prescribed in paragraph (1).
(i) Confirming that pharmaceutical risk management is being carried out properly andsmoothly.
(ii) Prepare and maintain records related to the implementation of pharmaceutical risk
management.
4 In cases where a manufacturer and seller of a prescription drug has a safety
management supervisor perform the tasks listed in each item of Article 97 of theRegulations in drug risk management in accordance with the Post-Marketing Safety
Management Operational Procedures, etc. and the drug risk management plan, themanufacturer and seller of the prescription drug shall have the safety management
supervisor make a record of such tasks, report it in writing to the safety
management supervisor, and have the safety management supervisor retain therecord. (2) When having the Safety Management Executives perform the duties listed
in each item of Article 97 of the Regulations, the Safety Management Executives

shall have the Safety Management Executives prepare the records, report them inwriting to the Safety Management Executives, and have the Safety Management
Executives retain them.
(Risk Management of Medical Devices)
Article 9-3 A manufacturer and seller of an Advanced Controlled Medical Device shall,when conducting risk management of medical devices, etc., have a Chief Marketing
Authorization Holder or a Safety Management Officer perform the following duties(i) A written plan (hereinafter referred to as "medical device risk management plan")that describes the following matters for each medical device risk management to be
conducted (i) A written plan that describes the following matters (hereinafterreferred to as the "Medical Device Risk Management Plan") for each risk
management of medical devices, etc. to be conducted(a) Matters to be specifically considered with respect to the safety and efficacy of
medical devices(b) An outline of information collection, investigations or tests on the safety and efficacyof the medical device (including a summary of the information that the manufacturer
or seller of the highly controlled medical device has obtained through post-marketingsurveillance, etc. (meaning post-marketing surveillance, etc. prescribed in Article 2,paragraph 1 of the Ministerial Ordinance on Standards for Implementation of PostMarketing Surveillance and Testing of Medical Devices; the same shall apply
hereinafter in this b). The same shall apply hereinafter in this paragraph (b)).
(c) Outline of activities to minimize risks associated with the use of medical devices(d) Status of implementation and timing of evaluation of risk management of medical
devices, etc.
(e) Other necessary matters(ii) revise the risk management plan for medical devices, etc., when it is deemednecessary for the implementation of risk management of medical devices, etc.
(iii) When a risk management plan for medical devices, etc. is prepared or revised
pursuant to the preceding item, the date of the revision shall be noted on the risk
management plan for medical devices, etc. and the plan shall be preserved.
(2) A manufacturer and seller of an advanced controlled medical device shall keep a
copy of the risk management plan for medical devices, etc. at the office where theChief Manufacturing and Marketing Officer performs his/her duties, and shall also

keep a copy of the matters described in the risk management plan for medical
devices, etc. at other offices where he/she performs risk management for medical
devices, etc. that the office is responsible for. (2) A copy of the risk management
plan for medical devices, etc. shall be kept at the office in which the person
responsible for the business is located.
(3) A manufacturer and seller of an advanced controlled medical device shall, in
accordance with the post-marketing safety management operational procedures,etc. and the risk management plan for medical devices, etc., have the person in
charge of safety management perform risk management for medical devices, etc.
(excluding the implementation of investigations and tests pertaining to the safety
and efficacy of medical devices or in vitro diagnostic products). (3) The Minister of
Health, Labour and Welfare shall have the chief safety management officers performthe following duties in addition to the duties prescribed in paragraph (1).
(i) Confirming that risk management of medical devices, etc. is conducted properly andsmoothly.
(ii) Prepare and preserve records related to the implementation of risk management of
medical devices, etc.
(4) A manufacturer and seller of an advanced controlled medical device shall, when
having the person responsible for safety management implement the tasks listed ineach item of Article 114-59 of the Rules among the risk management of medical
devices, etc., based on the post-marketing safety management operational
procedures, etc. and the medical device risk management plan, have the person
responsible for safety management implement the tasks, prepare records thereof, (2)When having the Safety Management Executor perform the duties listed in each itemof Article 114-59 of the Regulations, the Safety Management Executor shall have
the Safety Management Execution Manager prepare a record of the duties, report itin writing to the Safety Management Manager, and have the Safety Management
Executor retain it.
(Post-marketing surveillance)
Article 10 A manufacturer and seller of a prescription drug shall conduct a postmarketing surveillance (which is conducted for a period of six months after the drug
is put on the market to promote the proper use of the drug in medical practice andto promptly identify the occurrence of cases, etc. listed in Article 228-20, paragraph(1), item (i) a, c (1) through (5) and g and item (ii) a of the Regulations). (iii) "Drugrisk management" means the management of the risk of a drug as a part of drug risk
management. (2) In the case where the Minister of Health, Labour and Welfare
conducts the following activities (hereinafter the same shall apply in this Article) (2)In cases where the Chief Marketing Authorization Holder or the Safety Management
Officer (hereinafter the same shall apply in this Article) performs the following
duties, the Chief Marketing Authorization Holder or the Safety Management Officer
shall be required to perform the following duties.
(i) For each post-marketing surveillance to be conducted, a written implementation
plan (hereinafter referred to as "post-marketing surveillance implementation plan")that describes the following matters based on the drug risk management plan (i) For
each post-marketing surveillance to be conducted, a written implementation plan(hereinafter referred to as "post-marketing surveillance implementation plan") shallbe prepared based on the drug risk management plan, which shall include thefollowing(a) Purpose of the post-marketing surveillance(b) Methods of post-marketing surveillance(c) Period of conducting post-marketing surveillance(d) Other necessary matters(ii) Revise the post-marketing surveillance protocol when deemed necessary for the
implementation of the post-marketing surveillance.
(iii) When a post-marketing surveillance protocol is prepared or revised pursuant to
the preceding item, the date shall be noted on the post-marketing surveillance
protocol and it shall be preserved.
(2) The manufacturer and distributor of a prescription drug shall keep a copy of the
post-marketing surveillance implementation plan at the office where the Chief
Marketing Authority conducts its business and at other offices where the postmarketing surveillance is conducted.
(3) The manufacturer and seller of a prescription drug shall, in accordance with thepost-marketing safety management operational procedures, etc., the drug risk
management plan, and the post-marketing surveillance implementation plan, have theperson responsible for safety management conduct the post-marketing surveillanceand shall have the person responsible for safety management perform the following
duties in addition to the duties prescribed in paragraph 1(i) Ensure that the post-marketing surveillance is conducted properly and smoothly.
(ii) Prepare and preserve records related to the implementation of the post-marketingsurveillance.

4 In cases where a manufacturer or distributor of a prescription drug has the Safety
Administration Manager perform the tasks listed in each item of Article 97 of theRegulations in the immediate post-marketing surveillance in accordance with the
Post-Marketing Safety Management Operational Procedures, etc., the drug risk
management plan and the post-marketing surveillance implementation plan, themanufacturer or distributor shall have the Safety Administration Manager prepare
records thereof, (2) In cases where the Safety Management Execution Manager isrequested to perform the tasks listed in each item of Article 97 of the Regulations,
the Safety Management Execution Manager shall have the Safety Management
Execution Manager prepare the records, report them in writing to the Safety
Management Executives, and have the Safety Management Executives preservethem.
(as applied mutatis mutandis)
Article 10-2 The provisions of the preceding Article shall apply mutatis mutandis to a
manufacturer and seller of a regenerative medicine product. In this case, the term
"Article 228-20(1)(i)(a), (c)(1) to (5) and (g) and (ii)(a) of the Regulations" inparagraph (1) of the preceding Article shall be deemed to be replaced with "Article
228-20(1)(i)(c)(1) to (5) and (4)(i)(a) and (f) and (ii)(a) of the Regulations" and"conducted as drug risk management (2) In the same paragraph, the term "inaccordance with Article 23-25, paragraph (1) or Article 23-37, paragraph (1) of theAct" in item (i) shall be deemed to be replaced with "in accordance with a drug risk
management plan for each post-marketing surveillance" and the term "inaccordance with a drug risk management plan for each post-marketing surveillance"
in item (i) of the same paragraph shall be deemed to be replaced with "inaccordance with a drug risk management plan for each post-marketing surveillance",in paragraph (3) of the same Article shall be read as "Post-Marketing Safety
Management Operational Procedures, etc., Drug Risk Management Plan", "PostMarketing Safety Management Operational Procedures, etc., Drug Risk Management
Plan" in paragraph (4) of the same Article shall be read as "Post-Marketing Safety
Management Operational Procedures, etc.", "each item of Article 97 of theRegulations" in paragraph (3) of the same Article shall be read as "Article 137 of theRegulations", and Article 137-59," and "each item of Article 97 of the Regulations"shall be read as "each item of Article 137-59 of the Regulations" in paragraph (4) of
the same Article.
(Self-inspection)

Article 11 A Class I manufacturing and marketing business operator must have aperson designated in advance conduct periodic self-inspections of the operations
related to post-marketing safety management in accordance with the postmarketing safety management operational procedure manual, etc.
(2) When the person designated in advance in the preceding paragraph is the person in
charge of safety management, the Class I manufacturing and marketing suppliermust have the person in charge of safety management prepare and preserve a
record of the self-inspection set forth in the preceding paragraph.
(3) When the person designated in advance in Paragraph 1 is other than the person
responsible for safety management, the Class I manufacturer or distributor shallhave said person prepare a record of the self-inspection set forth in Paragraph 1,
report it in writing to the person responsible for safety management, and have theperson responsible for safety management preserve it.
4 The Class I manufacturer or distributor must have the safety manager report theresults of the self-inspection in writing to the Class I manufacturer or distributor
and the general manufacturing and marketing manager, and retain a copy of thereport.
(5) A Class I manufacturing and marketing manager shall have the Chief Manufacturingand Marketing Officer consider the necessity of improving post-marketing safety
management based on the results of the self-inspection set forth in Paragraph 1,
and if necessary, have him or her take the necessary measures and prepare arecord thereof.
6 The Class I manufacturer or distributor must have the person responsible for safety
management preserve the records set forth in the preceding paragraph.
(Education and training for those engaged in work related to post-marketing
safety management)
Article 12 A Class I manufacturer or distributor must have a general manufacturingand marketing manager prepare and keep an education and training plan.
2 A Class I manufacturer or distributor must have a person designated in advancesystematically provide education and training on post-marketing safety management
to persons engaged in work related to post-marketing safety management, in
accordance with the Operational Procedures for Post-Marketing Safety

Management, etc. and the education and training plan set forth in the preceding
paragraph.
(3) When the person designated in advance in the preceding paragraph is the person in
charge of safety management, the Class I manufacturer or distributor must have theperson in charge of safety management prepare and preserve records of theeducation and training set forth in the preceding paragraph.
(4) When the person designated in advance in Paragraph 2 is other than the person
responsible for safety management, the Class I manufacturer or distributor shallhave said person prepare a record of the education and training in Paragraph 2,
report it in writing to the person responsible for safety management, and have theperson responsible for safety management retain the record.
5 The Class I manufacturer or distributor must have the safety manager report theresults of the education and training to the general manufacturing and marketing
manager in writing and retain a copy of the report.
Chapter 3 Post-Marketing Safety Management Standards for Class II
Manufacturers and Distributors(Organization and staff related to safety assurance operations)
Article 13 A Type II manufacturer and seller must have sufficient personnel with theability to properly and smoothly perform safety assurance services.
(2) A Class II manufacturing and marketing business operator must appoint a person in
charge of safety assurance operations (hereinafter in this Chapter referred to as a"safety management representative") who satisfies the following requirements (1) A
person who is responsible for safety management(i) The applicant shall have the ability to perform safety assurance services properly
and smoothly.
(ii) the person is not a member of a department pertaining to the sale ofpharmaceuticals, etc., and is not otherwise likely to hinder the proper and smooth
performance of the services for ensuring safety.
3 The department that performs safety assurance tasks (excluding tasks to be
performed by persons other than the Safety Management Officer) must be
independent from the departments related to the sale of drugs and otherdepartments that may interfere with the proper and smooth performance of safetyassurance tasks. (3) The department that performs safety assurance tasks

(excluding tasks to be performed by persons other than the safety management
representative) must be independent from the department related to the sale ofpharmaceutical products and other departments that may hinder the proper andsmooth performance of the safety assurance tasks.
(as applied mutatis mutandis)
Article 14 The provisions of Article 3, Articles 5 to 10 (excluding Article 5 paragraph (1)items (v) and (vii), Article 7 paragraph (2), Article 8 paragraph (2), Article 9 paragraph(2) items (ii) and (iii), Article 9-2 paragraph (4), Article 9-3 paragraph (4) and Article
10 paragraph (4)), Article 11 and Article 12 shall apply mutatis mutandis to a Class II
manufacturing and marketing agent. (2) The provisions of Article 3, Article 4, Article
5, Article 6, Article 7, Article 8, Article 9, Article 10, Article 11 and Article 12 shallapply mutatis mutandis. In this case, the term "the Chief Marketing Authorization
Holder for Medical Devices, etc. prescribed in Article 23-2-14(2) of the Act or the
Chief Marketing Authorization Holder for Regenerative Medicine, etc. prescribed in
Article 23-34(2) of the Act" in Article 3 shall be deemed to be replaced with "or the
Chief Marketing Authorization Holder for Medical Devices, etc. prescribed in Article
23-2-14(2) of the Act" and the same shall apply to Article 11 and Article 12. The
term "Article 9-2, paragraph (1), item (i)" in Article 5, paragraph (1), item (vi) shall bedeemed to be replaced with "Article 9-2, paragraph (1), item (i) as applied mutatis
mutandis pursuant to Article 14," the term "Article 10, paragraph (1)" shall be deemed
to be replaced with "Article 10, paragraph (1) as applied mutatis mutandis pursuant to
Article 14," and the term "the Safety Management Manager or the Safety Management
Execution Manager" in Article 7, paragraph (1) shall be deemed to be replaced with"the Safety Management Manager or the Safety Management Execution Manager.
The term "safety of medical devices" in Article 9-3 paragraph (1) items (a) and (b)shall be deemed to be replaced with "safety of medical devices or in vitro diagnostic
drugs," the term "medical devices" in item (c) of the same paragraph shall be deemed
to be replaced with "medical devices or in vitro diagnostic drugs," and the term
"safety of medical devices" in paragraph (3) of the same Article shall be deemed tobe replaced with "safety of medical devices or in vitro diagnostic drugs.

Chapter IV Post-Marketing Safety Management Standards for Class III
Manufacturers and Distributors

(as applied mutatis mutandis)
Article 15 The provisions of Article 3, Articles 6 through 9 and Article 13 (excluding
Article 7, paragraph (2), Article 8, paragraph (2) and Article 9, paragraph (2), items (ii)and (iii)) shall apply mutatis mutandis to a Class III manufacturing and marketing agent.
(2) The provisions of Article 3 (excluding Article 7, paragraph 2, Article 8, paragraph
2, and Article 9, paragraph 2, items 2 and 3) shall apply mutatis mutandis. In this case,the term "the Chief Marketing Authorization Holder for Medical Devices, etc.
prescribed in Article 23-2-14(2) of the Act or the Chief Marketing Authorization
Holder for Regenerative Medical Products prescribed in Article 23-34(2) of the Act"in Article 3 shall be deemed to be replaced with "or the Chief Marketing Authorization
Holder for Medical Devices, etc. prescribed in Article 23-2-14(2) of the Act," and theterm "Article 23-2-14(2) of the Act" in the same Article shall be deemed to be
replaced with "Article 23-2-14(2) of the Act. (2) The term "Article 13 paragraph (2)as applied mutatis mutandis pursuant to Article 15" in Article 13 paragraph (2) of the
Act shall be deemed to be replaced with "Article 13 paragraph (2) as applied mutatis
mutandis pursuant to Article 15," the term "following based on the Post-Marketing
Safety Administration Operational Procedures, etc." in Article 6 paragraph (1) shall bedeemed to be replaced with "following," the term "following based on the PostMarketing Safety Administration Operational Procedures, etc." in Article 7 paragraph(1) shall be deemed to be replaced with "following" and the term "a Safety
Management Manager or Safety Management Implementation Manager" in Article 7
paragraph (1) shall be deemed to be replaced with "following. In the same paragraph,in item (i), the term "the preceding Article and Article 10" shall be deemed to be
replaced with "the preceding Article as applied mutatis mutandis pursuant to Article
15", the term "the person in charge of information on medical devices, etc. or on
regenerative medical products" in item (iii) of the same paragraph shall be deemed tobe replaced with "the person in charge of information on medical devices, etc.", theterm "in accordance with Post-Marketing Safety Management Operation Procedures,etc. and then" in Article 9 paragraph (1) shall be deemed to be replaced with "then"and the term "in accordance with the Post-Marketing Safety Management Operation
Procedures, etc." in the same paragraph shall be deemed to be replaced with "then.
(2) The term "a person in charge of safety management implementation" in Article 9,paragraph (1) shall be deemed to be replaced with "a person other than a person in
charge of safety management," the term "based on the Post-Marketing Safety

Management Operational Procedures, etc., then" in Article 9, paragraph (2) shall bedeemed to be replaced with "then," and the term "Post-Marketing Safety
Management Operational Procedures, etc." in paragraph (3) of the same Article shallbe deemed to be replaced with "documents".

Chapter V Miscellaneous Provisions(Preservation of records pertaining to safety assurance operations)
Article 16 The retention period for documents and other records that are to beretained pursuant to the provisions of this Ministerial Ordinance shall be five years
from the date on which said records are no longer used. However, the retention
period for the following records shall be the periods specified in the respective
items.
(i) records pertaining to biological products and regenerative medical products(excluding those listed in the following item and item (iii)) (ii) Records pertaining tobiological products and regenerative medical products (excluding those listed in thefollowing item and item (iii)): Ten years from the date of ceasing to be used(ii) Records pertaining to specified biological products and designated regenerative
medical products prescribed in Article 68-7(3) of the Act: 30 years from the date on
which they are no longer used(iii) Records pertaining to Specified Maintenance Managed Medical Equipment andInstalled Controlled Medical Equipment prescribed in Article 114-55 paragraph (1) of
the Ordinance (excluding those listed in the preceding item) (iii) Records pertaining
to specified maintenance management medical devices and installation management
medical devices prescribed in Article 114-55 paragraph (1) of the Rules (excluding
those listed in the preceding item)(iv) Self-inspection prescribed in Article 11 (including the cases where it is appliedmutatis mutandis pursuant to Article 14) (iv) Records pertaining to self-inspection
prescribed in Article 11 (including the cases where it is applied mutatis mutandis in
Article 14) and education and training prescribed in Article 12 (including the cases
where it is applied mutatis mutandis in Article 14) (v) Records pertaining to selfinspection prescribed in Article 11 (including the cases where it is applied mutatis
mutandis in Article 14) and education and training prescribed in Article 12 (including
the cases where it is applied mutatis mutandis in Article 14)

(2) Notwithstanding the provisions of this Ministerial Ordinance, a manufacturer anddistributor shall not distribute the post-marketing safety management procedure,etc. prescribed in Article 5 (including the cases where it is applied mutatis mutandis
pursuant to Article 14) (hereinafter referred to as "post-marketing safety
management procedure, etc." in this chapter). 2 Notwithstanding the provisions of
this Ministerial Ordinance, a manufacturing and marketing distributor shall preserve
records in accordance with the post-manufacturing and marketing safety
management operational procedures, etc. prescribed in Article 5 (including cases
where it is applied mutatis mutandis pursuant to Article 14) (hereinafter in thischapter referred to as "post-manufacturing and marketing safety management
operational procedures, etc."). (2) A manufacturer and seller may have a person
designated by the manufacturer and seller preserve said records in place of theperson who is required to preserve the records pursuant to this Ministerial
Ordinance in accordance with the post-manufacturing and sales safety management
operation procedures, etc. prescribed in Article 5 (including cases where it is appliedmutatis mutandis pursuant to Article 14).
Supplementary Provisions
This Ministerial Ordinance shall come into effect as from April 1, 2005.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 26 of March 11, 2013) (Extract)(Effective date)1 This Ministerial Ordinance shall come into effect as from October 1, 2006.
(Transitional measures)
2 The provisions then in force shall remain applicable to the post-marketingsurveillance of drugs approved prior to the enforcement of this Ministerial
Ordinance.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 13 of February 26, 2006)
This Ministerial Ordinance shall come into effect as from April 1, 2006.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 87 of July 30, 2006) (Extract)(Effective date)Article 1 This Ministerial Ordinance shall come into force as from the date ofenforcement of the Act for Partial Revision of the Pharmaceutical Affairs Act, etc.
(hereinafter referred to as the "Revised Act"). Article 1 This Ministerial Ordinanceshall come into effect as from the date of enforcement of the Act for Partial
Revision of the Pharmaceutical Affairs Act, etc. (hereinafter referred to as the"Revised Act") (November 25, 2006).
(Transitional measures in accordance with the partial revision of the
Ministerial Ordinance on Standards for Post-Marketing Safety Control of
Pharmaceuticals, Quasi-Drugs, Cosmetics and Medical Devices)
Article 9 A programmed highly controlled medical device (meaning a medical device thatis a highly controlled medical device program or a recording medium on which theprogrammed highly controlled medical device program is recorded. The same shallapply hereinafter in this Article).

Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 28 of November 21, 2006)
This Ministerial Ordinance shall come into effect as from the date of promulgation.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 44 of March 26, 2007) (Extract)(Effective date)
Article 1 This Ministerial Ordinance shall come into effect as from the date ofpromulgation.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 80 of July 31, 2007) (Extract)(Effective date)
Article 1 This Ministerial Ordinance shall come into effect as from the date ofpromulgation.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 124 of November 24, 2007)
This Ministerial Ordinance shall come into effect as from the date of promulgation.
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 155 of August 31, 2020) (Extract)(Effective date)Article 1 This Ministerial Ordinance shall come into effect as from the date ofenforcement (September 1, 2020) of the Act for Partial Revision of the Act on
Quality, Efficacy and Safety Assurance, etc. of Pharmaceuticals and Medical Devices(Act No. 63 of 2027).
Supplementary Provisions (Ordinance of the Ministry of Health, Labour andWelfare No. 15 of January 29, 2021) (Extract)(Effective date)
Article 1 This Ministerial Ordinance shall come into force as from the date ofenforcement (August 1, 2021) of the provisions of Article 1, item (ii) of the Act for
Partial Revision of the Act on Quality, Efficacy and Safety Assurance, etc. of
Pharmaceuticals and Medical Devices (hereinafter referred to as "Revised Act").
This Ministerial Ordinance shall come into force as from the date of enforcement of
the provisions prescribed in Article 1, item (ii) of the Supplementary Provisions(August 1, 2021).