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GENERAL FACTS

  • Scope of Certification
  • Application Type
  • Fees
  • Timeframe

DATATRAK SUPPORT

  • Process Review
  • Items required
  • Testing Assistance
  • Application Filing
  • Submission to the CAB
  • Issue of the certificate

 

Pre-process Review

Specifications of the device are reviewed, the application strategy is set, and a list of required tests is provided to the applicant.

The proposed certification strategy will ensure a smooth certification process (independent of host, system and/or family certification) and an "update friendly" certificate. As much as possible, the application will be prepared in a way future changes to the device will not require a full re-certification.

Documents required from the applicant

In order to get started, an application package(*3) with at least the following items will be required:

  • Company official name
  • Complete address
  • Legal Representative name and title
  • Distributor or Importer in Japan
  • ISO 9001 for the applicant and the assembly sub-contractor. If not available, orgchart and copy of the Quality Control process.
  • Device name
  • Applicable network interfaces
  • Dimensions
  • Weight
  • Technical description or specifications
  • Compliant test report prepared in accordance with applicable test cases
  • List of test apparatuses used with serial number, calibration date
  • Host installation/removal steps
  • External views with overall dimensions, location of interface ports
  • Location, design of the certification label
  • Bloc and circuit diagram
  • User’s manual

(*3) Please contact us for an updated and detailled checklist

Testing Assistance

The applicant can have the equipment tested at any test laboratory of his choice, or at his own test facilities as long as the test equipment are calibrated for less than a year prior to the testing of the device. Please note that some CABs ask for the complete coordinates of the calibration body.

If a test report for another country or regulatory agency is already available, we can check whether the test results can be used for the japanese certification, saving time and costs.

Whether you have your equipment tested in your own facilities, or in a commercial test laboratory, we can provide:

  • pre-testing recommendations and advices
  • information concerning required tests
  • test methods explanation and device setup recommendations
  • regular reviews of test results prior to the issue of the final test report

If you do not have access to testing facilities, we can introduce you to domestic or foreign laboratories familiar with Japanese requirements.

Application Filing

Preparing the application in Japanese or English as per the format stipulated by the CAB requires the following steps:

  • preparation of the administrative documents (application cover pages) to be signed by the applicant
  • review, translation and format of the test report
  • preparation of necessary drawings and bloc diagrams as per the CAB requirements
  • preparation and design of the certification label
  • translation of required support documents. (Manuals, Etc.)

Submission to the CAB

The application will be submitted to the CAB and questions regarding the contents of the file will be answered on your behalf. Whenever possible, questions will be directly answered by our experts. Questions requiring your help will immediately be forwarded to your attention by phone or E-mail. When available, a copy of the submission certificate, showing the reserved certification number will be E-mailed to your attention.

Issue of the certificate

Once the device has obtained certification, the original certificate will be sent to your attention with a copy of the complete application package.

For More Information... don't hesitate to contact us !

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