ESS ESS JPN In-Vitro Diagnostics

Regulatory ESSENTIAL

Japan - In-Vitro Diagnostics

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

In vitro diagnostic; IVD devices; IVD devices; CMDE; Electronic registration; NMPA; UDI regulation; UDI Code; IMDRF; Classification Rule; ISO 15223-1 symbol; vigilance

Scope:	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.
Stakeholders:	Manufacturer, Importer
Legislation in force:	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) IVD Definition (Article 2) (14) The term "in-vitro diagnostic" as used in this Act refers to pharmaceuticals intended exclusively for use in the diagnosis of diseases, which are not directly used in the bodies of humans or animals.
Application national:	Japan, IVD Products, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)
Countries:	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)
ROGER WILLCO ID:	#dy65
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Content of this Essential

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 license)

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, 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

In Vitro Diagnostic (IVD)

Japan