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Regulatory ESSENTIAL
Japan - In-Vitro Diagnostics

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, IVD Products, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)
Countries: Image for JP Japan,  
Status: Published 2023-09-18 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-18 by Michael Loerzer: Legislation in force for this PCT, In Vitro Diagnostic (IVD)
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:

In Vitro Diagnostic (IVD)

Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostic devices in Japan, based on the
- Act on Pharmaceuticals and Medical Devices" (PMD Act)
- MHLW and PMDA documents/guides

In-Vitro-Diagnostics are regulated under the "Pharmaceuticals and Medical Devices" Acts.
The main information is provided in: Regulatory ESSENTIAL JPN Medical Devices. This ESSENTIAL lists the IVD specific information only.'

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)?

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

Equipment authorization (approval process)

Classification Rules
here you will get related hyperlink(s)

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

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:


Code, ContinentJPN, Asia
Economic AreaAPEC
Official LanguageJapanese
Standard InstituteJSA - Japanese Standards Association |
HS CodememberYes - since 1964

Price and ordering:

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