JAPAN’S NEW QMS CONFORMITY

ASSESSMENT SYSTEM
Quality management system regulations and
requirements.

Author
Michiharu Miayara
President & CEO, Emergo Japan
(Japan) Tokyo
www.EmergoGroup.com

22 June 2015
The Japanese PMDL and updated QMS requirements
In November 2014, Japan’s Pharmaceutical Affairs Law (PAL) covering medical device registration
requirements was replaced by the Pharmaceutical and Medical Device Law (PMDL), and the new law
has been in force from November 25, 2014.

The new law brings changes to the Quality Management System in Japan. In some cases, fewer firms
need a Conformity Assessment. There is also a clearer divide between domestic and foreign
manufacturers in terms of who needs what kind of assessment.

Who is an applicant for QMS Conformity Assessment?

Two of the routes to approval are PMA and PMC. Pre-market Approval (PMA, or Shonin) is for
Controlled Class II, Highly Controlled Class III or Highly Controlled Class IV devices. Pre-market
Certification (PMC, or Ninsho) is for Specified Controlled Class II devices).

Under the old law (PAL), manufacturing sites were required to implement a QMS conforming to the
MHLW Ministry Ordinance No.169 (QMS Regulation) and undergo QMS Conformity Assessment by
the Pharmaceuticals and Medical devices Agency (PMDA) for PMA devices or a Registered
Certification Body (RCB) for PMC devices.

To register a medical device through either the PMA or PMC routes, the application of QMS
Conformity Assessment (Tekigousei Chosa) must be submitted in conjunction with a PMA
or PMC application.

An applicant and a holder of PMA or PMC must implement a QMS and apply for QMS Conformity
Assessment.

Generally, a manufacturer’s Marketing Authorization Holder (MAH) is an applicant and a holder of

PMA or PMC, but a foreign manufacturer may also hold a PMA or PMC and apply for QMS
Conformity Assessment. This is generally the case if the firm selects to register under the Foreign
Special Approval System through its Japanese in-country representative, known as the Designated
Marketing Authorization Holder (DMAH).

While the applicant of QMS Conformity Assessment is as stated above, the following sites are
subject to QMS Conformity Assessment:

• MAH

• Foreign manufacturer with the Foreign Special Approval System and DMAH
• Registered manufacturing establishment

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Manufacturer registration system
The old law (PAL) required a domestic device manufacturer to obtain a manufacturer license
(Kyoka), while a foreign manufacturer was required to obtain a foreign manufacturer accreditation
(Nintei).

Under the new PMDL, a new registration system (Toroku) has been established requiring the
following:

• Domestic manufacturers must register their manufacturing establishment with the

authorities at their local prefectures

• Foreign manufacturers must register their manufacturing establishment with the

Pharmaceuticals and Medical Devices Agency (PMDA)

A foreign manufacturer having a Foreign Manufacturer Accreditation before enforcement

of the PMDL is treated as a registered manufacturer (Minashi Toroku Seizogyosha) under
the PMDL. Such firms’ registrations are valid until their current accreditations expire, and
then they must re-register for Foreign Manufacturer Registration.

Registration scope
Some manufacturers may have complicated manufacturing processes at multiple manufacturing
establishments. The PAL had required a manufacturer license (Kyoka) or foreign manufacturer
accreditation (Nintei) for all firms involved in the manufacturing process after receiving parts and
materials.

Under the PMDL’s manufacturer registration system, only manufacturing establishments falling into
certain categories must be registered:

Registration Scope of Medical Device

Class I Software Recording

Registration Medical Medical Medical medium of
Category device device device Software MS
Design ○ N/A ○ ○
Key manufacturing
○ ○ N/A N/A
process
Sterilization ○ ○ N/A N/A
Warehouse of final
○ ○ N/A ○
product in Japan

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Registration Scope of IVD

Registration Category IVD Radioactive IVD Class I IVD

Design ○ ○ N/A

Filling process ○ ○* ○

Warehouse of final
○ ○ ○
product in Japan
*all the processes from filling process

A foreign manufacturer’s Foreign Manufacturer Registration Number must be printed on the

product registration application (e.g., PMA or PMC Application), and the Foreign Manufacturer
Registration application must be submitted to the PMDA in advance.

Kijun Tekigoshou and exemption of QMS conformity assessment

After a successful assessment, a Certificate of QMS Conformance (Kijun Tekigoshou) will be issued,
and this certificate is valid for five years.

The manufacturing sites (Establishment) listed on the certificates of QMS Conformance are exempt
from future conformity assessments when devices from the same product group (Seihingun) on
those certificates are registered with the PMDA or RCB.

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ISO 13485 versus Japan QMS regulation
Under the PAL, licensed manufacturers or accredited foreign manufacturers had a responsibility to
implement QMS based on the MHLW Ministry Ordinance No. 169 (QMS Regulation) requirements
with the Regulation for Building and Facilities, and MAHs had to implement Good Quality Practice
(GQP) and Good Vigilance Practice (GVP) to qualify for MAH licenses.

Under the PMDL, MAHs and foreign manufacturers applying for or holding PMA or PMC
registrations under the Foreign Special Approval System have a responsibility to implement
QMS instead of GQP (GVP must still be implemented separately).

The relationship among these regulations is as follows:

Under PAL Responsibility Under PMDL

Regulation for Building and Facilities

Manufacturer
QMS QMS*

GQP
MAH
GVP GVP

* The registered manufacturer shall manufacture under MAH’s (or PMA/PMC holding foreign
manufacturer’s) QMS umbrella (practically this can be accomplished by implementation of a
separate QMS by the registered manufacturer).

Configuration of new Japan QMS regulation

QMS under the PMDL is made up of the following regulations:

• MHLW Ministry Ordinance No. 169 (Revised QMS Regulation)

• MHLW Ministry Ordinance No. 94 (Taisei Syorei or QMS Structure Regulation)
Taisei Syorei or QMS Structure Regulation is designed to maintain the organization of MAH
responsibilities under QMS requirements for licensing, e.g., assignment of qualified general manager
(Sokatsu Seizo Hanbai Sekininsya), quality control responsible manager (Kokunai Hinshitsugyomu
Uneki Sekininsya) and management representative (Kanrisekininsya) roles.

Under the PAL, an MAH had to implement a GQP system according to the GQP Regulation. Since
GQP has been repealed under the PMDL, relative requirements of GQP have not been covered by
the revised QMS regulation.

The following is an index of the revised QMS regulation:

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Chapter 1 General Provisions (Article 1 to Article 3)

Chapter 2 Basic Requirements Regarding Manufacturing Control and Quality Control of

Medical Devices, etc.

Section 1 General Requirements (Article 4)

Section 2 Quality Management System (Article 5 to Article 9)

Section 3 Management responsibility (Article 10 to Article 20)

Section 4 Resource Management (Article 21 to Article 25)

Section 5 Product Realization (Article 26 to Article 53)

Section 6 Measurement, Analysis and Improvement (Article 54 to Article 64)

Chapter 3 Additional Requirements Regarding Manufacturing Control and Quality

Control of Medical Devices, etc. (Article 65 to Article 72-3)

Chapter 4 Manufacturing Control and Quality Control of Biological Medical Devices, etc.
(Article 73 to Article 79)

Chapter 5 Manufacturing Control and Quality Control of Radioactive In Vitro Diagnostic

Reagents (Article 80 and Article 81)

Chapter 6 Application mutatis mutandis, etc. to Manufacturers, etc. of Medical

Devices, etc. (Article 82 to Article 84)

To think about implementation of the Japan QMS Regulation, it is useful to understand each
requirement by sub-system configured as below.

Sub-System Requirements of Japan QMS Regulation

Article 5: General Requirements for Quality Management System
Article 7: Quality Manual
Article 10: Management Commitment
Article 12: Quality Policy
Article 13: Quality Objectives
Quality Management
Article 14: Quality Management System Planning
Article 15: Responsibility and Authority
Article 16: Responsible Engineering Manager
Article 17: Internal Communication
Article 18: Management Review

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 Article 19: Review Input
Article 20: Review Output
Article 21: Provision of Resources
Article 22: Personnel
Article 23: Competence, Awareness and Training
Article 56: Internal Audit
Article 77: Training
Article 30: Design and Development Planning
Article 31: Design and Development Inputs
Article 32: Design and Development Outputs
Design Control Article 33: Design and Development Review
Article 34: Design and Development Verification
Article 35: Design and Development Validation
Article 36: Control of Design and Development Changes
Article 6 Section 2 and 3: Documentation of Quality
Management System
Product Documentation Article 26: Planning of Product Realisation
Article 74: Documents Related to Manufacturing Control and
Quality Control
Article 24: Infrastructure
Article 25: Work Environment
Article 40: Control of Production and Service Provision
Article 41: Cleanliness of Products and Contamination Control
Article 42: Installation Activities
Article 43: Servicing Activities
Article 44: Manufacturing Control of Sterile Medical Devices
Article 45: Validation of Processes for Production and Service
Provision
Manufacturing
Article 46: Validation of Sterilization Process
Article 47: Identification
Article 48: Traceability
Article 49: Traceability of Specially Designated Medical Devices
Article 50: Status Identification
Article 51: Customer Property
Article 52: Preservation of Products
Article 53: Control of Monitoring and Measuring Devices
Article 58: Monitoring and Measurement of Products

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 Article 60: Control of Nonconforming Products
Article 73: Infrastructure of Manufacturing Sites of Marketing
Approval Holder, etc. of Specified Biological Medical Devices,
etc.
Article 75: Process Control
Article 76: Testing
Article 80: Infrastructure of Registered Manufacturing Sites of
Radioactive In Vitro Diagnostic Reagents
Article 81: Compliance with Regulations for Manufacturing
Control and Quality Control of Radiopharmaceuticals
Article 54: Measurement, Analysis and Improvement
Article 55: Feedback
Article 57: Monitoring and Measurement of Processes
CAPA Article 61: Analysis of Data
Article 62: Improvement
Article 63: Corrective Actions
Article 64: Preventive Actions
Article 37: Purchasing Process
Purchasing Article 38: Purchasing Information
Article 39: Verification of Purchased Products
Article 6 Section 1: Documentation of Quality Management
System
Article 8: Control of Documents
Article 9: Control of Records
Article 59: Monitoring and Measurement of Specially Designated
Control of Documents & Medical Devices
Records
Article 67: Retention Period of Quality Management System
Documents
Article 68: Retention Period of Records
Article 78: Control of Documents and Records
Article 79: Exceptions in Retention of Records
Article 11: Customer Focus
Article 27: Determination of Requirement Related to the
Customer Products
Article 28: Review of Requirements Related to Products
Article 29: Customer Communication
Article 65: Quality Management System of Registered
MAH related
Manufacturing Site

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 Article 66: Additional Requirements Regarding Quality
Management System
Article 69: Reporting Adverse Events, etc.
Article 70: Relationship with Good Vigilance Practice (GVP)
Article 71: Duties of General Marketing Supervisor of Medical
Devices, etc.
Article 72: Domestic Quality Assurance Manager
Article 72-2: Other Items to be Complied
Article 72-3: Duties of Appointed Marketing approval Holders for
Foreign Manufacturers of Medical Devices, etc.

Japan’s QMS Regulation has been developed based on ISO 13485 quality management
system requirements, and most Japanese requirements are compatible with ISO 13485
requirements.

It should be noted that there are some gaps between ISO 13485 and Japanese QMS requirements,
including issues such as retention period of documents and records, MAH-related requirements and
so forth.

The requirements with regard to the sub-system related for MAH and related functions must be
considered for Japanese QMS implementation as part of a PMA or PMC submission, as well as for
undergoing QMS conformity assessment.

To learn more:
Emergo helps medical device companies with regulatory compliance and market access worldwide.
To learn more, visit www.emergogroup.com/services

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