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 license) 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 license) 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 a table 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 a table

Code, Continent	JPN, Asia
Economic Area	APEC
Official Language	The official language is Japanese.
Standard Institute	JSA - Japanese Standards Association | https://www.jsa.or.jp/en/
HS Codemember	Yes - since 1964