In Japan, the pharmaceutical industry operates under strict regulatory oversight by the Pharmaceutical and Medical Devices Agency (PMDA). Established in 2004, PMDA functions within the Ministry of Health, Labour and Welfare (MHLW). The regulatory landscape is primarily governed by the Pharmaceuticals and Medical Devices Law (PMDL), which outlines the requirements for drug approval, clinical trials, manufacturing, and marketing authorization. Companies seeking to introduce pharmaceutical products into the Japanese market must navigate various types of registration applications, including New Drug Applications (NDA) for new products, Marketing Authorization Holder (MAH) Applications for market entry, and Generic Drug Applications for approval of generic versions of existing drugs. Understanding these regulations and application processes is crucial for companies operating in Japan's pharmaceutical sector.

1. JAPAN: ORGANISATION OF
PMDA, PHARMACEUTICAL
LAWS & REGULATIONS, TYPES
OF REGISTRATION
APPLICATION
PARUL INSTITUTE OF PHARMACY
PRESENTED BY:
Anjali Yadav
2nd Sem M.PHARM
Regulatory Affairs
1
Anjali Yadav

2. CONTENT
Introduction
Organisation of
PMDA
Pharmaceutical
Laws and
Regulations
Types of
Registration
Application
References
2
Anjali Yadav

3. INTRODUCTION
PMDA (Pharmaceuticals and Medical Devices Agency) is
Japanese regulatory agency, working together with Ministry of
health and labour welfare (MHLW).
The PMDA was established in April 2004 in order to serve in
areas of review of drugs and medical devices, post – marketing
safety measures, relief services for adverse health effects.
There obligation is to protect the public health by assuring
safety, efficacy and quality of pharmaceuticals and medical
devices.
The role of the PMDA is to provide concerning the clinical
trials of new drugs and medical devices, and to conduct
approval reviews and surveys of the reliability of application
data.
3
Anjali Yadav

4. FUNCTIONS
• Drug and medical device testing
• Scientific review of market
authorization applications based
on Japanese Pharmaceutical law
• Advice in clinical trials or in the
preparation of dossiers for the
registration procedure (NDA)
• Inspection and Conformity
assessment of Good Clinical
Practice (GCP), Good
Laboratory Practice (GLP) &
Good Practice Systems and
programs (GPSP)
• Auditing of manufacturers to
ensure they conform to Good
Manufacturing Practice (GMP)
and have a suitable Quality
Management System (QMS). 4
Anjali Yadav

5. PMDA TRIANGLE SYSTEM
REVIEW
RELIEF
SAFETY
SAFETY
TRIANGLE
SYSTEM
PMDA focuses on
3 key services
which is a Safety
Triangle System.
5
Anjali Yadav

6. PHARMACEUTICAL LAWS
AND REGULATIONS
Pharmaceutical administration in Japan is based on
various laws and regulations, consisting mainly of:
• Pharmaceutical and Medical Device Act
• Law Concerning the Establishment for Pharmaceuticals
and Medical Devices Organization
• Law Concerning Securing Stable Supply of Blood
Products
• Poisonous and Deleterious Substances Control Law
• Narcotics and Psychotropics Control Law
• Cannabis Control Law
• Opium Law
• Stimulants Control Law
6
Anjali Yadav

7. PHARMACEUTICAL LAWS
AND REGULATIONS
7
1. Pharmaceutical and Medical Device Act
The Pharmaceutical and Medical Device Act are to improve public
health through regulations required to assure quality, efficacy, and
safety of drugs, quasi-drugs, cosmetics, medical devices, and
regenerative medicine products and to prevent hazard and expansion
of hazard in public health caused by use of those products, as well as
through measures required to promote R&D of drugs, medical
devices and regenerative medicine products.
Anjali Yadav

8. PHARMACEUTICAL LAWS
AND REGULATIONS
8
2. Law Concerning the Establishment for Pharmaceuticals
and Medical Devices Organization
This law establishes the Pharmaceuticals and Medical Devices
Agency (PMDA), which is responsible for the evaluation and
approval of pharmaceuticals and medical devices in Japan. The
PMDA conducts reviews of new drug applications, monitors
post-market safety, and enforces regulatory compliance to
protect public health.
Anjali Yadav

9. PHARMACEUTICAL LAWS
AND REGULATIONS
9
3. Law Concerning Securing Stable Supply of Blood
Products
This law governs the collection, processing, storage, and
distribution of blood and blood products in Japan. It aims to
ensure the safety and availability of blood products for medical
use while safeguarding the health of blood donors and
recipients.
Anjali Yadav

10. PHARMACEUTICAL LAWS
AND REGULATIONS
10
4. Poisonous and Deleterious Substances Control Law
This law regulates the handling, storage, transportation, and
disposal of poisonous and deleterious substances in Japan. It
establishes controls to prevent misuse, accidents, and
environmental contamination associated with these substances,
which include hazardous chemicals, pesticides, and industrial
materials.
Anjali Yadav

11. PHARMACEUTICAL LAWS
AND REGULATIONS
11
5. Narcotics and Psychotropics Control Law
This law regulates the production, import, export, distribution,
and prescription of narcotics and psychotropic substances in
Japan. It aims to prevent drug abuse, trafficking, and diversion
while ensuring access to controlled substances for legitimate
medical purposes under strict supervision and regulation.
Anjali Yadav

12. PHARMACEUTICAL LAWS
AND REGULATIONS
12
6. Cannabis Control Law:
This law prohibits the cultivation, possession, sale, and use of
cannabis (marijuana) in Japan. It imposes penalties for
violations and establishes controls to prevent the misuse and
diversion of cannabis, which is classified as a controlled
substance with no recognized medical use under Japanese law.
Anjali Yadav

13. PHARMACEUTICAL LAWS
AND REGULATIONS
13
7. Opium Law:
Similar to the Narcotics and Psychotropics Control Law, the
Opium Law regulates the production, import, export,
distribution, and prescription of opium and its derivatives in
Japan. It aims to prevent opium abuse and diversion while
allowing for medical use under strict regulation and
supervision.
Anjali Yadav

14. PHARMACEUTICAL LAWS
AND REGULATIONS
14
8. Stimulants Control Law:
This law regulates the production, import, export, distribution,
and prescription of stimulant drugs, such as amphetamines and
methamphetamines, in Japan. It aims to prevent stimulant
abuse, trafficking, and diversion while ensuring access to these
drugs for legitimate medical purposes under strict supervision
and regulation.
Anjali Yadav

15. TYPES OF
REGISTRATION
APPLICATION
Japan has a well-established
regulatory framework governing
the approval and marketing of
pharmaceutical products.
The Pharmaceuticals and
Medical Devices Agency
(PMDA), along with the
Ministry of Health, Labor, and
Welfare (MHLW), oversees the
registration process for
pharmaceuticals.
Various types of registration
applications are required
depending on the stage of drug
development and intended use.
15
Anjali Yadav

16. TYPES OF
REGISTRATION
APPLICATION
Investigational New Drug
New Drug Application
Abbreviated New Drug
Application
Biologic License Application
(BLA)
Orphan Drug
Medical Device
16
Anjali Yadav

17. INVESTIGATIONAL NEW
DRUG
• The Japanese regulatory authority follows the Common
Technical Document (CTD) drug application format and
hence the applicant should prepare the Investigational New
Drug (IND) application and documents as per the CTD format.
• For drugs that are still in the testing Phase.
• The primary objective of the IND application is to obtain
approval from the regulatory authorities to conduct clinical
trials with investigational drugs in Japan. This application
serves to ensure the safety and efficacy of the drug candidates
before they are administered to human subject.
17
Anjali Yadav

18. COMPONENTS OF
INVESTIGATIONAL NEW
DRUG APPLICATION
1. Chemical and Pharmaceutical Information
2. Nonclinical data
3. Clinical study Protocol
4. Investigator’s Brochure
18
Anjali Yadav

19. COMPONENTS OF
INVESTIGATIONAL NEW
DRUG APPLICATION
1. Chemical and Pharmaceutical Information: Detailed
information regarding the chemical composition of the
investigational drug, its manufacturing process, and its
pharmaceutical form is provided in the application.
2. Nonclinical Data: Preclinical studies play a crucial role in
evaluating the safety profile of the investigational drug. This
section of the application includes data from pharmacology,
toxicology, and pharmacokinetics studies conducted in laboratory
settings.
19
Anjali Yadav

20. COMPONENTS OF
INVESTIGATIONAL NEW
DRUG APPLICATION
3. Clinical Study Protocol: A well-defined clinical study
protocol outlines the objectives, study design, dosing regimen,
and safety monitoring procedures for the proposed clinical trials.
It also includes information on patient eligibility criteria and
study endpoints.
4. Investigator's Brochure: This document provides
comprehensive information about the investigational drug,
including its pharmacological properties, pharmacokinetics, and
safety profile. It serves as a reference for investigators
conducting clinical trials.
20
Anjali Yadav

21. INVESTIGATIONAL
NEW DRUG APPROVAL
PROCESS
21
Anjali Yadav

22. Basic Investigation
Screening Tests
Study of Manufacturing techniques/Formulations
and Pharmaceutical Research
Phytochemistry, Toxicity on GLP, Pharmacology &
Pharmacokinetics
Evaluation of Non – Clinical Studies
INVESTIGATIONAL
NEW
DRUG
APPROVAL
PROCESS
22
Anjali Yadav

23. Clinical Trial Notification to PMDA
Receipt of Notification
Review of Notification
Guidance on Investigation Required
INVESTIGATIONAL
NEW
DRUG
APPROVAL
PROCESS
23
Anjali Yadav

24. NEW DRUG APPLICATION
• A New Drug Application (NDA) is a pivotal document
submitted by a pharmaceutical company to regulatory
authorities, such as the Pharmaceuticals and Medical Devices
Agency (PMDA) in Japan, seeking approval to market and
distribute a new pharmaceutical product.
• This comprehensive application serves as the primary vehicle
through which the company communicates essential
information about the new drug to the regulatory agency,
demonstrating its safety, efficacy, and quality for the intended
therapeutic use.
24
Anjali Yadav

25. COMPONENTS OF NEW
DRUG APPLICATION
1. Chemistry, Manufacturing, and Controls (CMC) Information
2. Nonclinical Pharmacology and Toxicology Studies
3. Clinical Data
4. Drug Labelling and Prescribing Information
5. Risk Management Plan (RMP)
6. Regulatory Commitments
25
Anjali Yadav

26. COMPONENTS OF NEW
DRUG APPLICATION
1. Chemistry, Manufacturing, and Controls (CMC)
Information: This section provides detailed data on the
composition, manufacturing process, and quality control
measures of the new drug. It encompasses information on the
drug substance, drug product formulation, manufacturing
facilities, and analytical methods used to assess product
quality and stability.
26
Anjali Yadav

27. COMPONENTS OF NEW
DRUG APPLICATION
2. Nonclinical Pharmacology and Toxicology Studies:
Preclinical data from pharmacological and toxicological studies
conducted in laboratory animals are included to assess the drug's
pharmacological activity, potential toxicity, and safety profile.
These studies provide crucial insights into the drug's mechanism
of action, potential side effects, and dose-response relationships.
27
Anjali Yadav

28. COMPONENTS OF NEW
DRUG APPLICATION
3. Clinical Data: The cornerstone of the NDA is the clinical
data obtained from human trials conducted during the drug
development process. These studies are designed to evaluate the
drug's safety and efficacy in patients with the target disease or
condition. The NDA includes detailed summaries of clinical trial
protocols, results, and analyses, along with safety monitoring
data and adverse event reports.
28
Anjali Yadav

29. COMPONENTS OF NEW
DRUG APPLICATION
4. Drug Labelling and Prescribing Information: The
proposed labelling for the new drug, including package inserts,
prescribing information, and patient information leaflets, is
provided in the NDA. This information outlines essential details
such as indications, dosage and administration instructions,
contraindications, warnings, precautions, and potential adverse
reactions associated with the use of the drug.
29
Anjali Yadav

30. COMPONENTS OF NEW
DRUG APPLICATION
5. Risk Management Plan (RMP): In some cases, especially
for drugs with complex safety profiles or significant risks, the
NDA may include a risk management plan aimed at minimizing
and managing potential risks associated with the drug's use. The
RMP outlines specific pharmacovigilance activities, risk
minimization strategies, and post-marketing surveillance plans
to ensure ongoing evaluation of the drug's safety profile.
30
Anjali Yadav

31. COMPONENTS OF NEW
DRUG APPLICATION
6. Regulatory Commitments: The NDA may also include
commitments from the pharmaceutical company to conduct
additional post-approval studies, implement risk mitigation
measures, or provide further data to address specific regulatory
concerns raised during the review process
31
Anjali Yadav

32. NEW DRUG
APPLICATION
APPROVAL PROCES
32
Anjali Yadav

33. Application
PMDA
Approval
Review
MHLW Evaluation
& Licensing
Compliance
Review
GMP Review
Pharmaceutical
Affairs and Food
Sanitation Council
Experts
Evaluation
Committees
Pharmaceutical
Affairs Section
Consultation
Enquiry
Response
Minister of MHLW
(Final Evaluation)
Approval
NEW
DRUG
APPLICATION
APPROVAL
PROCESS
33
Anjali Yadav

34. ABBREVIATED NEW DRUG
APPLICATION
• In Japan, the PMDA reviews generic drug applications, and
this includes the assessment of bioequivalence studies. This
bioequivalence assessment helps to confirm the quality,
efficacy, and safety of the product based on documents
submitted by applicants.
• In Japan, the drug product is considered to be a generic
drug, if it covers the following criteria:
• It contains an API (Active Pharmaceutical Ingredient),
• If the API has a different hydrate form or crystalline form
from the original drug, and
• If the API has the same chemical structure as the original
drug
34
Anjali Yadav

35. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
1. Product Development
2. Bioequivalence studies
3. Quality Control and Manufacturing
4. Regulatory submission
5. Review Process
35
Anjali Yadav

36. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
1. Product Development: Generic drug manufacturers in
Japan begin the development process by identifying a
reference product, usually a branded drug that has already
been approved and marketed. They then work to replicate
the active pharmaceutical ingredients (APIs) and
formulation of the reference product.
36
Anjali Yadav

37. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
2. Bioequivalence Studies: Similar to the requirements in the
United States, demonstrating bioequivalence is a critical aspect
process in Japan. Bioequivalence studies compare the
pharmacokinetic parameters of the generic product with those
of the reference product to ensure that they are equivalent in
terms of rate and extent of absorption.
37
Anjali Yadav

38. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
3. Quality Control and Manufacturing: The generic drug
manufacturer must adhere to strict quality control standards
and Good Manufacturing Practice (GMP) regulations
throughout the manufacturing process to ensure the
consistency and quality of the finished product.
38
Anjali Yadav

39. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
4. Regulatory Submission: Once the generic drug has been
developed and bioequivalence has been demonstrated through
studies, the manufacturer submits a Generic Drug Application
to the Pharmaceuticals and Medical Devices Agency (PMDA)
in Japan. This application includes comprehensive data on the
product's formulation, manufacturing process, bioequivalence
studies, stability data, and other relevant information.
39
Anjali Yadav

40. COMPONENTS OF ABBREVIATED
NEW DRUG APPLICATION
5. Review Process: The PMDA conducts a thorough review of
the Generic Drug Application to assess the quality, safety, and
efficacy of the generic product. This review process involves
evaluating the submitted data against regulatory standards and
requirements to determine whether the generic drug meets the
necessary criteria for approval.
40
Anjali Yadav

41. ABBREVIATED NEW
DRUG APPLICATION
APPROVAL PROCESS
41
Anjali Yadav

42. Applicant
Application
Incorporate Administrative Agency
PMDA (Pharmaceutical & Medical Device Agency)
Outcome of
Inspection
MHLW
GCP/ GLP/GMP Audit & Compliance
Foreign
Site
Manufacturing Plant
Prefectural
Government
Domestic
Site
GMP Inspection
Outcome of
Review
APPROVAL
ABBREVIATED
NEW
DRUG
APPLICATION
APPROVAL
PROCESS
42
Anjali Yadav

43. BIOLOGICS LICENSE
APPLICATION
• The PMDA’s office of biologicals provides consultations
concerning clinical trials of new biologic drugs and handles
biotechnology medicines, which includes biosimilars.
• Requirements for biologic drugs differ from general drugs
and depend on whether a biological product is a regenerative
medicine product or not.
• The MHLW designates a product as a biological drug after its
consultation with the Pharmaceutical Affairs and Food
Sanitation Council (PAFSC).
43
Anjali Yadav

44. BIOLOGICS LICENSE
APPLICATION
• Biosimilar drugs:
• Biosimilar drugs are considered as those drugs that are
“equivalent and homogenous to the reference biological
product in terms of efficacy, quality, and safety.”
• In Japan, the approval of biosimilar products tends to reduce
the amount of new information required and the timeline for
approval.
• The applicant can reduce the burden in case if it has
information gathered for its foreign license or approval.
44
Anjali Yadav

45. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
1. Product Development
2. Clinical Trials
3. Quality Control and Manufacturing
4. Comparative Studies
5. Post-Marketing Commitments
6. Labelling and Packaging
7. Risk Management Plan (RMP)
45
Anjali Yadav

46. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
1. Product Development: Biologics are complex therapeutic
products derived from living organisms or their
components, such as proteins, nucleic acids, or cells.
Product development involves extensive research and
development to characterize the biologic, establish
manufacturing processes, and conduct preclinical studies to
assess safety and efficacy.
46
Anjali Yadav

47. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
2. Clinical Trials: Clinical development for biologics typically
involves conducting clinical trials to evaluate safety and
efficacy in patients with the target disease or condition. These
trials are designed to generate robust data on the biologic's
therapeutic effects, dosing regimens, and safety profile.
47
Anjali Yadav

48. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
3. Quality Control and Manufacturing: Ensuring the quality
and consistency of biologic products is essential.
Manufacturers must adhere to strict quality control standards
and Good Manufacturing Practice (GMP) regulations
throughout the manufacturing process to produce biologics
that meet regulatory requirements.
48
Anjali Yadav

49. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
4. Comparative Studies: In addition to demonstrating the
safety and efficacy of the biologic product, comparative
studies may be required to establish similarity or comparability
to a reference product, especially if the biologic is a biosimilar
or interchangeable product. These studies assess similarities in
quality attributes, pharmacokinetics, pharmacodynamics, and
immunogenicity between the biologic and the reference
product.
49
Anjali Yadav

50. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
5. Post-Marketing Commitments: Regulatory authorities
may request post-marketing commitments as a condition for
approval, particularly for novel or complex biologics. These
commitments may include additional safety monitoring,
pharmacovigilance studies, real-world evidence generation, or
further clinical trials to address specific concerns or
uncertainties identified during the review process.
50
Anjali Yadav

51. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
6. Labelling and Packaging: The BLA submission includes
proposed labeling and packaging information for the biologic
product. This includes prescribing information, dosage
instructions, contraindications, warnings, precautions, adverse
reaction information, and other essential details intended for
healthcare professionals and patients.
51
Anjali Yadav

52. COMPONENTS OF BIOLOGICS
LICENSE APPLICATION
7. Risk Management Plan (RMP): A comprehensive risk
management plan may be required, particularly for biologics
with complex safety profiles or unique risks. The RMP
outlines strategies and measures to identify, minimize, and
manage risks associated with the use of the biologic product
throughout its lifecycle, including post-marketing surveillance
and risk mitigation activities.
52
Anjali Yadav

53. BIOLOGICS LICENSE
APPLICATION
APPROVAL PROCESS
53
Anjali Yadav

54. Applicant
Fulfil all requirements for Biosimilars
Application
Ministry of Health and Labour Welfare (MHLW)
PMDA
Review and Manufacturing Inspection
BIOLOGICS
LICENSE
APPLICATION
APPROVAL
PROCESS
54
Anjali Yadav

55. Schedule Meeting with Applicant
Complete detailed review report
MHLW’s Pharmaceutical & Food Safety Bureau
Forward Report
MHLW’s Review
APPROVE
BIOLOGICS
LICENSE
APPLICATION
APPROVAL
PROCESS
55
Anjali Yadav

56. ORPHAN DRUG
• Japan defines a disease as rare if fewer than 50,000 people are
affected. Pharmaceutical companies can request orphan drug
designation to treat such rare diseases.
• Criteria for drugs to obtain orphan drug designation
• The medical need is very high.
• The intended use is for severe diseases
• In addition, the drug needs to meet the following conditions
• No other drug or medical treatment is available for the
disease.
• The product under review exhibits significantly high efficacy
and safety compared with existing products.
• There exists a strong rationale for the use of the product.
56
Anjali Yadav

57. COMPONENTS OF ORPHAN
DRUG APPLICATION
1. Orphan Drug Designation
2. Clinical Development
3. Priority Review and Approval
4. Post-Marketing Commitments
57
Anjali Yadav

58. COMPONENTS OF ORPHAN
DRUG APPLICATION
1. Orphan Drug Designation: Before submitting an application
for approval, the drug must first receive orphan designation from
the PMDA. This designation is granted to drugs intended for the
treatment, diagnosis, or prevention of rare diseases that affect a
small number of patients in Japan. The criteria for orphan
designation are outlined in the "Orphan Drug Designation System"
provided by the PMDA.
58
Anjali Yadav

59. COMPONENTS OF ORPHAN
DRUG APPLICATION
2. Clinical Development: Similar to the development of non-
orphan drugs, clinical studies are conducted to evaluate the safety
and efficacy of the orphan drug. However, given the challenges of
conducting clinical trials for rare diseases with limited patient
populations, the PMDA may accept smaller or less conventional
trial designs, such as single-arm studies or studies with surrogate
endpoints.
59
Anjali Yadav

60. COMPONENTS OF ORPHAN
DRUG APPLICATION
3. Priority Review and Approval: Orphan drugs may be eligible
for priority review by the PMDA, which expedites the review
process to accelerate access to treatment for patients with rare
diseases. The PMDA evaluates the orphan drug application based
on its scientific merit, clinical data, and the unmet medical need for
patients with the rare disease.
60
Anjali Yadav

61. COMPONENTS OF ORPHAN
DRUG APPLICATION
4. Post-Marketing Commitments: As a condition for approval,
the PMDA may request post-marketing commitments, such as
additional safety monitoring or long-term efficacy studies, to
further evaluate the orphan drug's benefit-risk profile in real-
world clinical practice.
61
Anjali Yadav

62. MEDICAL DEVICE
• Registration of Medical devices and pharmaceuticals in
Japan is complicated, and high costs and long timeframes.
• In some cases, Japanese regulators require clinical trials
in Japan to be conducted.
• Product registration in Japan needs to be pursued
carefully and only after determining that there is a strong
market demand for your product.
• In order to market medical devices in Japan, a foreign
manufacturer has to obtain approval/certification or
submit notification.
62
Anjali Yadav

63. Class – 1 Class – 2 Class – 3 Class – 4
General
Medical
Device
Controlled
Medical
Device
Specially
Controlled
Medical
Device
Specially
Controlled
Medical
Device
Extremely Low
Risk
Low Risk Medium Risk High Risk
63
Anjali Yadav

64. Nebulizers, X-
ray film
X- ray imaging
device,
injection
needle,
Ultrasonic
diagnostic
device
Artificial
dialyzer,
Infusion Pump,
Artificial Bone
Pacemaker,
Coronary stent,
Artificial
Blood vessel
Self
Declaration
Third Party
Certification
Ministers
Approval
Third Party
Certification
Ministers
Approval
64
Anjali Yadav

65. REGISTRATION PROCEDURE
FOR MEDICAL DEVICES
The registration pathway
for your device is
determined by its
classification and
associated Japan Medical
Device Nomenclature
(JMDN).
To market medical
devices in Japan, your
Marketing Authorization
Holder (MAH) must
register your device
through one of the
following procedures.
65
Anjali Yadav

66. REGISTRATION PROCEDURE
FOR MEDICAL DEVICE
Premarket
Notification
(Todoke)
Pre-market
certification
(Ninsho)
Pre-market
approval
(Shonin)
66
Anjali Yadav

67. REGISTRATION PROCEDURE
FOR MEDICAL DEVICE
1. Premarket Notification (Todoke)
To register General Medical Devices (Class I), you
must file a pre-market submission to the PMDA. There is
No review/assessment by the PMDA will be conducted.
67
Anjali Yadav

68. REGISTRATION PROCEDURE
FOR MEDICAL DEVICE
2. Premarket Certification (Ninsho)
Class II (and a limited number of Class III) devices which have
an associated certification standard (JIS), are subject to pre-
market certification. Many, but not all, Japan Industrial
Standards are based on existing ISO/IEC standards. MAH will
file the application with a Registered Certification Body (RCB).
The process is similar to the European CE marking process
where reviews are outsourced to a third party similar to a
Notified Body.
68
Anjali Yadav

69. REGISTRATION PROCEDURE
FOR MEDICAL DEVICE
3. Premarket Approval (Shonin)
Class II and III devices without a specific certification
standard are subject to the pre-market approval process. This
also applies to all Class IV devices. In this case your MAH will
file a pre-market approval application with the PMDA and
ultimately obtain approval from the MHLW.
69
Anjali Yadav

70. MEDICAL DEVICE
APPROVAL
PROCEDURE
70
Anjali Yadav

71. Categorize the Medical Device
Identify the class of device a per PMD act and Japanese Medical
Device Nomenclature (JMDN) Codes
Establish QMS requirements that comply with the PMD Act and
MHLW
Obtain Necessary authorization and licenses
Appoint an MAH: Class – 1 device not require MAH , While all
other class devices require MAH for registration 71
Anjali Yadav

72. Submit the authorization documents according to requirements, all
documents must be in Japanese
Foreign Manufacturers shall submit Foreign Manufacture
Registration (FMR)
Request a QMS Inspection
Class – 1 – Do not require
Class – 2 – QMS audit by Registered Certification Body (RCB)
Class – 3 & 4- QMS audit by PMDA
On site audits are typically required for “NEW” devices with no
existing JMDN Code, Class – 4 devices. And those requiring
clinical investigation
72
Anjali Yadav

73. If Manufacturer get an approval from authority, then manufacture
market their product into Japanese Market
Submit the authorization documents according to requirements, all
documents must be in Japanese
73
Anjali Yadav

74. REFERENCE
1. Medical Device Registration Processes
of Japan: A Comparative Study with U.
S. A. and Europe
https://globalresearchonline.net/ijpsrr/v
79-1/17.pdf
2. The Drug Approval Process In Japan
https://credevo.com/articles/2020/04/15/t
he-drug-approval-process-in-japan/
3. Generic drug approval process in Japan
https://www.researchgate.net/figure/Gene
ric-drug-approval-process-in-Japan-
Main-Data-Required-for-the-Approval-
of-Generic_fig3_325145465
4.PMDA Organisation
https://www.pmda.go.jp/english/about-
pmda/outline/0003.html
5. Pharmaceutical Laws and Regulations
https://www.jpma.or.jp/english/about/parj
/eki4g6000000784o-att/2020e_ch02.pdf
74
Anjali Yadav

75. 75
ありがとう
Anjali Yadav