Record ID 100606

Title
Medical devices - Market access - Japan @ Statutory and regulatory requirements and related documents - Record released 2011-01-02
Source
[Conforlex]
Issued
2011-01-02
Record released
2011-01-02
Record updated
Not updated yet
Geographical area
Japan
Language
en
Sector
Healthcare
Normative state
Statutory or regulatory
Consumer versus non-consumer product
Consumer products and non-consumer product
Publisher
Conforlex
Description

Medical devices
Market access - Japan
Statutory and regulatory requirements and related document

 

Recent information

 

2010-11-02
Japan Issues Minor Changes to FMA Application [PBM] link

 

2010-10-05
Japan Eases Approval Process for Select Medical Devices
[medtechinsider] link

 

PMDA - Pharmaceuticals and Medical Devices Agency
- News and Reports [PMDA] link
- Updates [PMDA] link
- Pharmaceuticals and Medical Devices Safety Information [PMDA] link
- PMDA Medical Safety Information [PMDA] link

 

Recent JIS standards [JSA] link

 

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Regulations and Procedures

 

Regulatory process for medical devices [Emergo Group] link [pdf, 177 kB]

 

How to Approach to Japanese Medical Devices Market [MiRQ] link
- Overview of process approach for marketing medical devices to Japanese
  market [MiRQ] link [pdf, 142 kB]
- Japanese regulatory framework for medical devices [MiRQ] link [pdf, 151 kB]
- Steps to register a medical device in Japan [MiRQ] link [pdf, 178 kB]
- Product registration process [MiRQ] link [pdf, 158 kB]
- Clinical trial in Japan [MiRQ] link
- Post marketing surveillance and adverse event reporting
  [MiRQ] link [pdf, 109 kB]

 

"The creation of a Device Master File, called a "Seihin Hyojun Sho," is an essential step in obtaining approval to sell a medical device in Japan"
[Emergo Group] link
- see also [PMDA] link

 

Japan Quality Management System Compliance - MHLW Ordinance 169
[Emergo Group] link
- see also [PMDA] link

 

Marketing Authorization Holder (MAH) system [Emergo Group] link

 

Clinical Data Evaluation for Foreign Medical Device Companies Seeking Japanese PMDA Approval
[Emergo Group] link

 

- Regulatory System for Medical Devices in Japan [PMDA] link
- Accreditation of foreign manufacturers [PMDA] link
- Master File System [PMDA] link
- QMS Quality Management System [PMDA] link
- Ministerial Ordinances [PMDA] link
- Notifications [PMDA] link
- Other Regulatory Actions [PMDA] link
- Application for Approval-Frequently Asked Questions (FAQ) [PMDA] link

 

Post-marketing Safety [PMDA] link

 

Navigation of the regulatory process of the Japan PAL [BSI] link

 

How to obtain medical device approval in Japan [SGS] link

 

Japan market access [ul.com] link

 

Understanding Japan’s Medical Device Certification System [MDDI] link

 

Comparison of the U.S., EU, and Japanese Regulatory Systems
(Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets Investigation No. 332-474)
- page 108, source 1 [FDLP/EC] link [pdf, 2,6MB]
- page 108, source 2 [USITC] link [pdf, 2,6MB]

 

----------------------------------------------------------------------

 

Products Approved (medical devices)
- 2009 New Medical Devices [PMDA] link [pdf, 169 kB]
- relevant Google search results [Google] link

 

----------------------------------------------------------------------

 

Standards

 

Standards for medical devices [PMDA] link

 

- What is Certification Standard? [PMDA] link
- List of Certification Standards [PMDA] link

 

- What is Approval Standard? [PMDA] link
- List of Approval Standards [PMDA] link

 

- What is Review Guideline? [PMDA] link
- List of Review Guidelines [PMDA] link

 

- Other Information [PMDA] link
- Contacts [PMDA] link

 

- Recent JIS Publications [JSA] link
- JIS Standards on 'Medical Equipment and Safety Appliances' [JSA] link
- JIS List by Division [JSA] link
- JIS Standards [JSA] link
- JIS search [JSA] link
- Find ISO/IEC/JIS standards [JSA] link

 

Japanese Industrial Standards Committee [JISC] link

 

JEITA Standards - Industrial Electronics Equipment Standardization
[JEITA] link
- Electromedical Equipment [JEITA] link
- Medical Ultrasonic Equipment [JEITA] link

 

JEITA Standards [JEITA] link

 

----------------------------------------------------------------------

 

Japanese Law Translation [Ministry of Justice] link

 

An example: Electrical Appliances and Materials Safety Act
[Ministry of Justice] link

 

----------------------------------------------------------------------

 

Organizations

 

MHLW Ministry of Health, Labour and Welfare
The main regulatory body for creating laws and standards for medical devices and drugs in Japan is the Ministry of Health, Labour and Welfare (MHLW). Under the MHLW is the Pharmaceutical and Food Safety Bureau.  This bureau is in charge of setting pharmaceutical and medical device regulatory policy.
[MHLW] link

 

Pharmaceutical and Medical Safety Bureau [MHLW] link

 

PMDA The Pharmaceuticals and Medical Devices Agency
is another Japanese regulatory agency that works alongside the MHLW to ensure the safety, efficacy and quality of pharmaceuticals and medical devices. They review marketing authorization applications for pharmaceuticals and medical devices, and monitor post-marketing safety.
[PMDA] link

 

JAAME Japan Association for the Advancement of Medical Equipment
- Japanese web site [JAAME] link
- Translated from Japanese into English by Google Tranalsete [Google] link

 

JAMDI Japan Association of Medical Devices Industries
- Japanese web site [JAMDI] link
- Translation from Japanese into English by Google Translate [Google] link

 

JMED Japan Medical Devices Manufacturers Association
- Japanese web site [JMED] link
- Translation from Japanese into English by Google Translate [Google] link

 

HAPI The Japan Home-health Apparatus Industrial Association
- Japanese web site [HAPI] link
- Translation from Japanese into English by Google Translate [Google] link

 

JMOIA Japan Medical-Optical Equipment Industrial Association
- Japanese web site [JMOIA] link
- Translation from Japanese into English by Google Translate [Google] link

 

JDTA Japan Dental Trade Association [JDTA] link

 

AMDD The American Medical Devices and Diagnostics Manufacturers’ Association [AMDD] link

 

JIRA Japan Industries Association of Radiological Systems [JIRA] link

 

JAIMA Japan Analytical Instruments Manufacturers Association [JAIMA] link

 

"Medical Devices Institute of RA & QMS Co., Ltd."
"MiRQ" Co., Ltd. in Japan
[meddevmirq.com] link

 

JFMDA Japan Federation of Medical Devices Associations [JFMDA] link

 

NIHS National Institute of Health Sciences [NIHS] link

 

JEITA Japan Electronics and Information Technology Industries Association
[JEITA] link

 

EU-Japan Centre [EU-Japan Centre] link

 

EU Gateway [EU Gateway] link

 

Finland in Japan - Finpro - Finland Trade Center [Embassy of Finland] link

 

Relevant Google search results from the site buyusa.gov
- Latest [Google] link
- Any time [Google] link

 

Relevant Google search results
- Latest [Google] link
- Any time [Google] link

 

Record type
Notice
General application area
,
Organization function
Design, development, documentation, Marketing, sales, Quality management, regulatory affairs,
Keywords
AIMD, Active implantable medical device, Healthcare, IVD, In vitro diagnostic, Legislation, Market access, Master record, Medical device, Regulation, Statutory document

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