Medical Devices Regulations in Japan. PDF/PPT

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Medical Devices
Regulations in Japan

Presented by-
Aditya Kekan(Roll no.04)

Rushikesh Koshti(Roll no.05)
Anju Choudhary(Roll no.06) Guided by-
Dr. Ravindra Purohit


01 Introduction 02 Registration Procedures

The PMDA act Steps in regulatory approval
Regulatory Bodies Pre-market submission (Todokede)
Risk based classification of Medical devices Pre-market certification (Ninsho)

Pre-market approval (Shonin)

03 Quality System
04 Clinical Evaluation

Requirements and Investigation

Fast break scheme for
Medical device single audit programme

innovative medical devices
Labelling requirements
UDI requirements


• The Japanese medical device market is one of the largest in the world, behind Europe

and the United States.
• Despite being a very technologically developed country that is home to many large,

multinational medical device corporations, a high percentage of the medical devices
marketed and sold in Japan come from foreign manufacturers.

Key factors driving growth in Japanese medical device market:
• Geriatrics population
• Increase in lifestyle diseases and chronic health conditions
• Wider population base being covered under universal health coverage
• Regulatory changes to facilitate innovation
• Stringent PMDA regulations
• Lengthy and expensive process
• Documents need to be submitted in Japanese


1.1 Regulatory bodies
Ministry of Health, Labour and Welfare (MHLW)

o Japan’s Ministry of Health, Labour and Welfare (MHLW) located in Tokyo is the
regulatory body that oversees food and drugs in Japan, which includes creating and
implementing safety standards for medical devices and drugs.

o Its main responsibility is to handle policies and administrative.
o For ex. Final judgment on approval

Product withdrawal from market


The Pharmaceutical and Medical Devices Agency (PMDA)
o The Pharmaceutical and Medical Device Agency (PMDA) is an independent agency that is

responsible for reviewing drug and medical device applications.
o The PMDA works with the MHLW to assess new product safety, develop comprehensive

regulations, and monitor post-market safety.
o Also known as “Technical arm of MHLW”, the PMDA reviews, examines and analyzes the

data to assist MHLW measures.
o For ex. Approval Review of MD

QMS/GLP/GCP inspection
Collection and analysis of Adverse Event Reports


1.2 The PMD act ( The Pharmaceutical and Medical
Devices Act)

❑ Current Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act),
also known as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,
Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.

❑ The PMD Act affects all aspects of Japanese medical product registration, including in-country
representation, certification processes, licensing, and quality assurance systems.

❑ The PMD Act came into force on November 25, 2014 and replaced the Pharmaceutical Affairs Law (PAL).

Key features of PMD Act;
❑ Some Class III medical devices are able to undergo third party certification.
❑ Medical software programs are independently regulated.
❑ A new registration system for medical devices was introduced.
❑ Quality management systems (QMS) are streamlined. QMS inspection is conducted on the Marketing

Authorization Holder and is conducted per product family, not on individual products.


Pharmaceuticals and Medical devices amendment Act, 2019
The PMD Amendment introduced new provisions to prioritize certain products, including:
•SAKIGAKE designation system
•Priority review for specific uses, such as pediatric use
•Conditional Approval System
•Post-Approval Change Management Protocol (PACMP) for Medical Devices

The SAKIGAKE designation and the conditional early approval reviews had been operated based on the
administrative notification process prior to the amendment of the PMD Act.

The SAKIGAKE designation applies to medical devices for severe disease that are deemed safe and effective,
innovative, and are being developed initially in Japan. The process allows for prioritized consultation, in
which the waiting time is typically shortened from two months to one month, as well as providing a pre-
application consultation. There is also a prioritized review that can shrink the targeted review time from 12
to 6 months.


1.3 Classification of medical devices


Classification of In-vitro diagnostics





2.1 Medical Devices Regulation of Japan, EU and

Approval or Pre-market Third Party Certification Notified Body

(Low Risk Medical Certification (All Medical

Devices) Devices)

Minister’s Approval on
basis of PMDA review

(High Risk Medical


2.2 Regulatory Process and approval for Medical


General understanding of the stakeholders involved:

❑ In Japan, only a local entity qualified as a MAH or
DMAH may import and sell medical products to the
Japanese market.

❑ The MAH is an entity based in Japan that has obtained the
marketing authorization license.

❑ The MAH is the applicant and becomes the owner of the

❑ The foreign manufacturer controls the registration of the
product. The foreign manufacturer is the applicant and
becomes the owner of the approval/certification.

❑ The DMAH acts as the representative for the foreign
manufacturer during and after product registration.

Foreign Manufacturer Registration: Foreign companies that intend to manufacture drugs, quasi-drugs,
APIs or medical devices overseas and import them into Japan must be registered with the Ministry of Health,
Labour and Welfare (MHLW). This process is known as “Toroku”. It is a separate process from the product
registration process, and is required for obtaining product registration approval. Previously, it was known as
“Foreign Manufacturer Accreditation (FMA)”.


2.2.1 Steps in regulatory approval process
for MD

Step 1
• Determine classification of device according to the Pharmaceuticals and Medical Devices

Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes. JMDN code is a
database of medical device through JMDN code. E.g. 70067 000 ; If the code starts with 7 it
is unique to JMDN if starts with other digits it is based on GMDN.

Step 2
• For Class I devices, appoint an MAH in Japan.
• For all other classes, Appoint Marketing Authorization Holder (MAH or D-MAH) to manage

device registration in Japan.
• MAH or D-MAH will control your device registration.
Step 3
• Japanese manufacturers must register domestic facilities with local prefectural authorities.

Foreign manufacturers must submit a Foreign Manufacturer Registration (FMR) application
to the Pharmaceuticals and Medical Devices Agency (PMDA).


Step 4
• Implement Quality Management System (QMS) that complies with the PMD Act and Ministry of Health,

Labour and Welfare (MHLW) Ordinance #169.
• Ordinance #169 is based on ISO 13485.

Step 5
• For Class I devices, submit Pre-Market Submission to Pharmaceutical and Medical Devices Agency

• For Class II (Specified Controlled) devices, submit Pre-Market Certification application to a Registered

Certified Body (RCB) authorized to issue certifications.
• For Class II (Controlled) through IV devices, prepare Pre-Market Approval application as well as

registration dossier in Summary Technical Document (STED) format.
• Submit documents to PMDA.
• All documents must be in Japanese.

Step 6
• Most Class I devices do not require QMS conformity assessment.
• For Class II (Specified Controlled) devices, QMS audit by Registered Certification Body (RCB).
• For Class II (Controlled) through IV devices, QMS audit by PMDA.
• On-site audits are typically required for “New” devices with no existing JMDN code, Class IV devices, and

those requiring clinical investigations.


Step 7
• For all Class II through IV devices, QMS certificate will be issued by the PMDA or Registered Certification


Step 8
• For Class II (Specified Controlled) devices, Pre-Market Certificate issued by RCB.
• For Class II (Controlled) through Class IV devices, PreMarket Approval certificate issued by MHLW.

Step 9
• For all devices, a reimbursement application should be filed with Economic Affairs Division of MHLW if


Step 10
• Manufacturer may now begin marketing device in Japan. Approvals do not expire unless revoked or

product recalled.


2.3 Pre-market Submission (Todokede)
Todokede or pre-market submission procedures for general medical devices is
straight forward once the documentation is in place.
● allows for self-certification
● requires no review/assessment by the PMDA
● takes less than one month for processing
● can be processed with ease
● is referred to be approved, once submitted
● is not time-bound to expire


2.4 Pre-Market certification (Ninsho)

● Class II (and a limited number of Class III) devices which have an associated
certification standard (Japan Industrial Standard – JIS), are subject to pre-
market certification.

● Many, but not all, JIS are based on existing ISO/IEC standards.
● MAH file the application with a Registered Certification Body (RCB).
● The process is like the European CE Marking process where reviews are

outsourced to a third party like a Notified Body.


2.5 Pre-Market 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 a MAH will have to file a

pre-market approval application with the PMDA to obtain approval from
the MHLW.

● Class II products that do not hold, or comply, with the Ninsho Certification
Standard can be approved via the Shonin pathway.

● For Todokede and Shonin Regulatory pathways, the permission is granted
by the PMDA, whereas for Ninsho it is done by the third-party agency i.e.
Registered Certified Body.



Quality system Requirements 20


• The Japanese medical device Quality Management System requirements are stipulated in

MHLW Ministerial Ordinance No. 169 (2004) titled “the Ministerial Ordinance on Standards for
Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics”
(referred to as MHLW MO169).

• Commonly known as J-QMS ordinance.
• MHLW MO169 was initially established in 2004 in order to make the medical device QMS

requirements harmonized with international standard, ISO13485:2003. The ordinance has
been revised several times since its establishment.

Revision history, MHLW MO169

2004: Initial version published.

2014: The second chapter of the ordinance was revised to more align with ISO13485:2003.
The additional requirements to ISO13485:2003 were moved to the third chapter of the

2017: Requirements for re-manufacturing single-use device (R-SUD) were incorporated in the

2021: The second chapter of the ordinancwewww.Dauslo rMeixv.ciosmed to align with ISO13485:2016. 21


Changes made through J-QMS ordinance

2004 ordinance Revised J-QMS ordinance

Chapter 1: Chapter 1:
General Provisions Nearly identical General provisions

Chapter 2:
Requirements for manufacturing sites= Chapter 2:

ISO 13485 changed Basic requirements= ISO 13485

Chapter 3: Chapter 3: Requirement

Requirements for labelling manufacturers Additional requirements s applied to

Chapter 4:
Chapter 4:

Special requirements for animal-origin medical devices
Special requirements for animal-origin

Nearly identical
medical devices


Chapter 5: Chapter 5:
Mutatis mutandis applied to IVD reagent Requirements for radio-active IVD reagents

manufacturers Chapter 5-2: Requirements for R-SUD New

Chapter 6:
Mutatis mutandis applied to manufacturing sites New

infosheets/med-info-download-center/ 22


Additional clauses are made to chapter 2 Basic
requirements in recent 2021 version to harmonize with

ISO 13485:2016
the international standard, such as:

• Clause 4:Quality management
• Article 5-2: Marketing authorization holders and so system

forth must establish QMS based on risks of function, • Clause 5: Management
efficacy and safety of medical devices(Section 4.1.2 of responsibility
ISO13485:2016) • Clause 6: Resource management

• Article 5-6: When using software for QMS, the • Clause 7: Product/service
process of validation must be document.(Section realization

4.1.6 of ISO13485:2016) • Clause 8: Measurement analysis
and improvement

• Article 34: when using the statistical method for
validation of design and development, the method
and criteria of validation must be
documented.(Section 7.3.6 of ISO13485:2016)

• MHLW MO169 was revised to align with ISO13485:2016 in March 26, 2021. The transition period
is 3 years. Hence, Marketing Authorization Holders etc. and Registered Manufacturing Sites must
comply with the revised ordinance by March 25, 2024.

Ref: 23


QMS Inspection
• For medical devices and in vitro diagnostics, PMDA conducts on-site and document-based inspections

of the registered manufacturing sites (of products under review or approved products) located in
Japan or overseas, in order to ascertain whether their manufacturing facilities and manufacturing and
quality controls comply with Quality Management System (QMS).

• QMS inspection is part of the registration process.
• Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-MAH) to

represent them in Japan.
• Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a

Certificate of QMS Conformance (Kijun Tekigoshou) by either the PMDA or RCB.
• Certificates of conformance are valid for five years and include the registered product name, product

group (Seihingun), and manufacturing facility.
• Under the PMD Act, future conformity assessments focus on devices from the same product group

registered with the PMDA or RCB, rather than the manufacturing facility.
• The PMDA or a registered certification body will conduct audits at the MAH premises and all listed

manufacturing facilities submitted within one single application.

Ref: 24


QMS Inspection
QMS inspection are of two types:

✓ Pre-approval inspection

✓ Periodic Post approval inspection

QMS inspection is conducted per:
Generic names of Medical Devices and IVDs are grouped into
“Product Families” depending on factors such as mfg.

per Product (High risk Product) process, characteristics, usage method, risk etc..
E.g.: Cardiac pacemaker and defibrillator(under class IV)

per Generic name (not grouped Non-active instruments
into product family) Devices for stimulation or inhibition

Imaging devices utilizing ionizing radiation

per Product Family

Medical Device Single Audit Program (MDSAP) :
• Since 2015, Japan is a participant of the Medical Device Single Audit Program (MDSAP), an international

partnership between Japan, the U.S., Australia, Brazil and Canada.EU and WHO are official observers.
• It allows a single MDSAP audit report to substitute for individual country manufacturing requirements, and

unites QMS standards on a global scale.
Ref: 25


QMS Inspection Authority


• Class IV PMDA
• New medical devices
• Cell / Tissue-based medical devices

MEDICAL DEVICES • Class III and Class II (without CS*)

• Class III and Class II (with CS*) Registered certification body

• New drugs PMDA
• Radioactive drugs
• Products without CS*

• Products with CS* Registered certification body

* Certification standards

Ref: 26


QMS Inspection flow
Receive application of QMS inspection

Risk Assessment

Determine on-site or desktop inspection

On-site Inspection Desktop inspection

Conformity assessment (grading of nonconformities based on
their impact on QMS and occurrence)

Issue Compliance certification and inspection report 27

6 months


QMS Inspection
High possibility of desktop inspection if MAH or Mfg. sites have…

(1) Latest ISO13485 certification or audit report within 3 years of issue, issued by certification bodies
registered under the medical device regulation system of Japan, US, Europe, Australia or Canada

(2) Latest On-site QMS inspection report within 3 years of issue by registered certification bodies in Japan

(3) QMS inspection report issued by the foreign governments under MoU, etc

What is a Japanese Medical Device Master File?
• The Device Master File is one of the key differences between ISO 13485 and Ordinance #169.
• This document defines the product specifications and QMS requirements (Seihin Hyojun Sho), as

well as information about storage, labeling, packaging, testing, and MAH requirements.
• It is separate from the application file (Todokede, Ninsho, or Shonin) and similar to a European

Technical File.
• The PMDA is very particular about the content of the Device Master File. Supporting documents

and details must be consistent with the information submitted for the Todokede, Ninsho, or
Shonin – even the smallest differences can cause delays.

Ref: 28


Labelling requirements in Japan

• Medical device labeling requirements in Japan are specified by the Pharmaceuticals and
Medical Devices Agency (PMDA), in Article 52 of the Act on Securing Quality, Efficacy
and Safety of Products Including Pharmaceuticals and Medical Devices.

• In Japan, local labeling is listed on package inserts, ‘tempu bunsho’. The package inserts
should contain the information presented in the Instructions for Use (IFU) in Japanese.

• In December 2019, the Pharmaceuticals and Medical Devices Act was amended to
introduce e-Labeling officially, replacing paper labeling and adding a necessary scheme
that allows all healthcare professionals access to up-to-date labeling information.

• A code will be printed on the outer box so that the healthcare professional can access
labeling information. Paper labeling should be provided at initial delivery and at the time
of labeling revision by the Marketing Authorization Holder (MAH)/Wholesaler outside
the commercial pack.

• From August,2021 this amendment is enforced and e-labelling is made official.

• 29


UDI requirements
• Japan was an early promoter of standardized barcodes, but is still working towards

harmonizing their requirements with global UDI expectations.


MHLW published “Guidelines
for Placing Standard Codes 2019
(Barcode Marking) on Medical JFMDA (Japan Federation of PMD act, was amended to
Devices” Medical Device Associations) include, among other

published “UDI Operation
-direct marking on devices things, UDI labeling

Manual for Medical Devices,”
remained very limited. requirements for medical

further encouraging direct device packaging.
marking of barcodes on
specific types of medical

• Effective Dec 2022 and with stepwise implementation according to the type of device, bar
code labeling based on the international standards shall be required for immediate
containers/wrappings/retail packages of medical devices.

Ref: 30



Clinical Evaluation And Investigation 31



▪ Clinical trials for medical devices are becoming more common worldwide as medical devices
become more complex.

▪ The increased complexity demands clinical data that demonstrate devices’ safety and effectiveness.
▪ The approval process for medical devices in Japan, foreign clinical data are basically acceptable as

long as the data may be extrapolated to the Japanese medical environment in terms of intrinsic
factors such as body size.

▪ Japanese trials are required if no such clinical data are available. Even in such cases, global
multicentered clinical trials (including Japanese sites) are recommended to expedite the research
and development process

▪ Therefore, device lag still remains in certain therapeutic categories in which the extrapolation of
foreign clinical data to the Japanese medical setting is needed for Japanese regulatory approval



• Launched by MHLW in July 2017.
• The fast-break scheme is a system to approve innovative medical devices in Japan for which a

medical need exists in an expedited manner at an earlier stage of development, based on
clinical evidence not confined to rigorous prospective randomized controlled trials, but
including other adequate clinical data reasonably likely to predict clinical benefit and safety
(case studies, registries, and clinical research) based on a limited patient population in certain
clinical settings.

• The scheme is to be appClileidniocnalyl tToribaral nNd-onetwifimcaedtiicoalndevices that satisfy the following

✓ there are no appropriate alternative medical devices
✓ the target patient population is affected by life-threatening disease or serious disability in

daily life;
✓ some supporting clinical evidence is available;
✓ there is a post marketing commitment to an appropriate risk-management plan in

collaboration with relevant academic medical societies
✓ there is justification of difficulty in conducting a new prospective clinical trial.



Figure: Fast break scheme for innovative medical devices comparison with Traditional
approval process 34