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Regulatory ESSENTIAL
Japan - Medical Devices

Modular information package with all the essential information for compliant products in your target market.
Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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Stakeholders:      Manufacturer, Importer     
Application: Japan, Medical Devices, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)
Countries: Image for JP Japan,  
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Status: Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-18 by Michael Loerzer: Hints, Medical devices
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


Medical devices

Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of medical devices in Japan, based on the
- Act on Pharmaceuticals and Medical Devices" (PMD Act)
- Information provided by the athorities MHLW and PMDA

Health products are classified into four risk classes, according to the risk associated with their use.
Class I (extremely low risk) - General MDs
Class II (low risk) - Controlled MDs
Class III (medium risk) - Specially Controlled MDs
Class IV (high risk)- Specially Controlled MDs

Not in scope of this CRF:
- In-Vitro Diagnostics (see: ESSENTIAL JPN In-Vitro Diagnostics)'

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors
here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Sub-federal legislation of states/counties
here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
here you will get related hyperlink(s)

Abbreviations
here you will get textual information

Important abbreviations which are special for this legislation or theme.

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

IMDRF Membership
here you will get textual information

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required
here you will get textual information

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Classification Rules
here you will get related hyperlink(s)

Classification Rules
here you will get a image or chart

Nomenclature/Borderline Rules
here you will get textual information

Approval process (conformity assessment procedure)
here you will get a image or chart

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
here you will get related hyperlink(s)

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
here you will get related hyperlink(s)

e .g. formal application

Is a factory inspection legally required
here you will get textual information

Hints
here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
here you will get related hyperlink(s)

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
here you will get related hyperlink(s)

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
here you will get related hyperlink(s)

Clinical Investigation/Evaluation
here you will get related hyperlink(s)

Is in-country testing legally required?
here you will get textual information

Acceptance of foreign test reports
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
here you will get textual information

e. g. product label

Regulatory e-labelling allowed?
here you will get textual information

e. g. put the regulatory information and labels in a software menu

UDI marking
here you will get related hyperlink(s)

Required information on the product and/or packaging
here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
here you will get textual information

Regulated by the legal provisions

Medical Device Symbols
here you will get textual information

General Information:

   Japan

Code, ContinentJPN, Asia
Economic AreaAPEC
Official LanguageJapanese
Standard InstituteJSA - Japanese Standards Association | https://www.jsa.or.jp/en/
HS CodememberYes - since 1964

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