Regulatory ESSENTIAL
Japan - In-Vitro Diagnostics

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

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