Anwendungsbereich des Regulatory Essentials
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)
Geltende Rechtsvorschriften:
Short name: Act on Pharmaceuticals and Medical Devices" (PMD Act)
Content (Excerpt):
Chapter V Marketing and Manufacturing Businesses for Medical Devices and In-vitro Diagnostics
Section 1 Marketing and Manufacturing of Medical Devices and In-vitro Diagnostics(Articles 23-2 to 23-2-22)
Section 2 Registered Certification Bodies (Articles 23-2-23 to 23-19)
Chapter IX Handling of Pharmaceuticals, etc.
Section 5 Handling of Medical Devices (Articles 63 to 65)
Chapter XIII Supervision
Article 69 - On-Site Inspections
Chapter XVII Penalties (Articles 83-6 to 91)
Details of duties of Marketing Authorization Holders regarding manufacturing control and quality control of products.
Nationale Anwendungsebene:
Japan, Medical Devices, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)
Japan
Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-05-03 by Ina May: Required information on the product and/or packaging, Medical devices
Inhalt des Regulatory Essentials
| Regulatory market access conditions for the actor(s) |
Hier erhalten Sie textbasierte Informationen
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)
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| Sub-federal legislation of states/counties |
Hier erhalten Sie textbasierte Informationen
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.
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| FTA/MRA status with EU |
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)
Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?
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| Authority |
Hier erhalten Sie zugehörige weiterführende Links
Name of the authority for approval, registration, market surveillance and/or enforcement
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| Link/Reference to other reference document(s) |
Hier erhalten Sie zugehörige weiterführende Links
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| Abbreviations |
Hier erhalten sie eine Tabelle
Important abbreviations which are special for this legislation or theme.
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Formal and administrative requirements
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| Registration at related authority required? |
Hier erhalten Sie textbasierte Informationen
Product registration?
Manufacturer registration?
Importer / Representative registration?
if required.
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| Local representative legally required? |
Hier erhalten Sie textbasierte Informationen
[Yes/No]
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| IMDRF Membership |
Hier erhalten Sie textbasierte Informationen
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.
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| Database Entry required |
Hier erhalten Sie textbasierte Informationen
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| Hints |
Hier erhalten Sie zugehörige weiterführende Links
Specific recommendations, information or most common mistakes
|
Equipment authorization (approval process)
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| Classification Rules |
Hier erhalten Sie zugehörige weiterführende Links
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| Classification Rules |
Hier erhalten Sie ein Foto oder Diagram
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| Nomenclature/Borderline Rules |
Hier erhalten Sie textbasierte Informationen
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| Approval process (conformity assessment procedure) |
Hier erhalten Sie ein Foto oder Diagram
Means each legally required approval process prior placing on the market, importation or putting into service
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| Conformance document(s) to show compliance to the authority |
Hier erhalten Sie textbasierte Informationen
e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)
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| Conformance document validity and renewal |
Hier erhalten Sie zugehörige weiterführende Links
Validity for Conformance document name mentioned. For mandatory certification validity is important.
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| Which documents are required by an approval body? |
Hier erhalten Sie zugehörige weiterführende Links
e .g. formal application
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| Is a factory inspection legally required |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie zugehörige weiterführende Links
Specific recommendations, information or most common mistakes
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| Specific requirements for testing |
Hier erhalten Sie zugehörige weiterführende Links
e. g. is an accredited test lab. mandatory, limits, test samples, product description
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| General information to the application of standards |
Hier erhalten Sie zugehörige weiterführende Links
e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"
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| Source for standards for conformity assessment |
Hier erhalten Sie zugehörige weiterführende Links
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| Clinical Investigation/Evaluation |
Hier erhalten Sie zugehörige weiterführende Links
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| Is in-country testing legally required? |
Hier erhalten Sie textbasierte Informationen
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| Acceptance of foreign test reports |
Hier erhalten Sie textbasierte Informationen
|
| Hints |
Hier erhalten Sie textbasierte Informationen
Specific recommendations, information or most common mistakes
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Regulatory labelling, markings and user information
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| Regulatory label (mandatory) |
Hier erhalten Sie textbasierte Informationen
e. g. product label
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| Regulatory e-labelling allowed? |
Hier erhalten Sie textbasierte Informationen
e. g. put the regulatory information and labels in a software menu
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| UDI marking |
Hier erhalten Sie zugehörige weiterführende Links
|
| Required information on the product and/or packaging |
Hier erhalten Sie textbasierte Informationen
e. g. address of the manufacturer/importer, serial number
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| User instructions language(s) |
Hier erhalten Sie textbasierte Informationen
Regulated by the legal provisions
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| Medical Device Symbols |
Hier erhalten sie eine Tabelle
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Allgemeine Informationen
Japan
Code, Kontinent, Wirtschaftsraum
The official language is Japanese.
JSA - Japanese Standards Association | https://www.jsa.or.jp/en/
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