current language
Japan available in the following languages:
or select your TÜV Rheinland region / country website:
Choose country/ region and language

Download Document

Forms and Documents Download
Show all Hide all

DENAN(PSE) - Conformity Assessment for Specified Electrical Appliances and Materials

The certification process for PSE (DENAN) for Japan takes the following steps:

  1. Submission of application and test sample of the product designated for the Japanese market
  2. Review of the application documentation to check which standards have already been fulfilled and which still need to be fulfilled
  3. Conformity assessment to ensure all of the required standards are met for importing your product to the Japanese market
  4. Issue of conformity certificates for your electrical and electronic products

For more PSE (DENAN) information: METI - Electrical Appliance and Material Safety Law

PSE Mark

Application for Conformity Assessment for Specified Electrical Appliance and Material

Due to differences on the procedures, the contents of the files for foreign manufacturer and for Japanese notifying supplier are not same. Please use the concerned file.

  • If you are foreign manufacturer, please use the following files. (Updated: Sept 1, 2023)
    PDF Version WORD Version
  • If you are Japanese Notifying Supplier, please use the files in Japanese. (Updated: Sept 1, 2023)
    PDF Version WORD Version
  • Calculation basis of conformity assessment fee for electrical appliances and materials
    PDF Version


Testing and Certification Regulations

Decision Rule

North America ( cTUVus / NRTL and medical auditing/MDSAP)

Agreement and Testing and Certification Regulations of TUV Rheinland of North America, Inc.(TRNA)

Medical Devices (ISO13485 / MDD / IVDD / MDSAP / MDR )

If you are considering certification

Please contact our Customer Service Center.

TEL: +81 (0)45-470-1850 / Contact Form

If you are already using our certification services

Below are the documents that we ask our customers to submit before audit. Required document may vary depending on the standard and type of audit. Our coordinator will provide you with details.

Printing requests and printing orders

(Submit either the original or a PDF file)

For Certificate issued by TUV Rheinland Japan Ltd.

For Certificate issued by TUV Rheinland LGA Products GmbH (TRLP) / TUV Rheinland of North America, Inc. (TRNA)

Common format for MDD, IVDD, EN ISO 13485, MDSAP

Questions for Quoting

(Submit original)

Questions for Quoting (Rev.6)

This document is common to Certification Department of TÜV Rheinland LGA Products GmbH and TÜV Rheinland of North America Inc.

If the application scope varies (especially with product categories), documentation has to be handed in for each standard

Attachment to Questions for Quoting

(Submit PDF file)

Attachment to Questions for Quoting

In case you maintain MDD certificate (EC approval) for product(s) in Class IIa and IIb, please submit this form together with Questions for Quoting.

Surveillance Audit Checklist

Checklist Surveillance Audit Questionnaire

In case you apply Surveillance Audit or Re-certification audit, please submit this checklist.

Significant change notification

Product List and Application

(Submit original)

  • Product List and Application (Rev.0)
    In case of a (re-)certification audit, please enlist all information CE marks and in case of a surveillance audit, list up all modifications from the previous year (added, deleted or modified products ).

Laboratory Testing Service

Template documents for laboratory testing services at Global Technology Assessment Center (GTAC) are available in Japanese.

Global Technology Assessment Center (GTAC)

laboratory information