Forms and Documents Download

Product Safety

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

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. (Updated: Mar 4, 2016)

Please contact us for Type Classifications for Specified Electrical Appliances and Materials within the Scope of Registration of TRJ

The certification process for PSE (DENAN) for Japan takes the following five steps: For details, please refer to Application for Conformity Assessment for Specified Electrical Appliance and Material (PDF, 1.91 MB) in Download

  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: Mar 4, 2016)
    PDF Version (PDF, 1.91 MB) WORD Version (DOCX, 372 KB)
  • If you are Japanese Notifying Supplier, please use the files in Japanese. (Updated: Mar 4, 2016)
    PDF Version (PDF, 1.92 MB) WORD Version (DOCX, 377 KB)

Testing and Certification Regulations

North America ( cTUVus / NRTL )

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

Management System

General Terms and Conditions and Terms and Conditions of Certification

Medical Devices (ISO13485/ MDD/ IVDD/ CMDCAS)

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, EN ISO 9001, CMDCAS (SCC)

Questions for Quoting

(Submit original)

Questions for Quoting (Rev.19) (DOCX, 77 KB)

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 (Rev.3) (DOCX, 36 KB)

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

Surveillance audit checklist (Rev.3) (DOCX, 124 KB)

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

CE Marked Product List

(Submit PDF file)

There is no predetermined form. Please hand in a list covering all necessary items, referring to the below guide on how to write up the list.

Product List and Application

(Submit original)

  • Product List and Application MDD, AIMDD-GB (PDF, 1.05 MB)
    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 ).

CMDCAS Application

(Submit original)

CMDCAS Intent to sell

(Submit either the original or a PDF file)

If a product (line) on CMDCAS certificate falls under any of the following items, please hand in the following documentation.

(1) If the product (line) is applied to CMDCAS certification before receiving the Device License (CMDCAS certification audit or Extension audit)

(2) If a Device License has already been obtained, but the product (line) which is currently stopped selling is included in current CMDCAS certificate.

* In case you submit Printing Request for CMDCAS including Declaration of Intent to sell,
you don’t need to submit this document redundantly.

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