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    Issuance of Certificates For Medical Devices For Export: (1) Where Applications Should Be Submitted

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    Manas Mishra
    Japanese medical device manufacturers must obtain certificates from regulatory authorities to export devices to certain countries. These certificates confirm that devices were manufactured according to Japanese law. Manufacturers submit applications to OMETA, an organization that checks applications for validity and forwards them to the appropriate regulatory division. Applications must include request forms, device information, and documentation of approvals. OMETA assists manufacturers with the application process and certificate issuance.

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    Issuance of Certificates For Medical Devices For Export: (1) Where Applications Should Be Submitted

    Uploaded by

    Manas Mishra
    54 views2 pages
    Japanese medical device manufacturers must obtain certificates from regulatory authorities to export devices to certain countries. These certificates confirm that devices were manufactured according to Japanese law. Manufacturers submit applications to OMETA, an organization that checks applications for validity and forwards them to the appropriate regulatory division. Applications must include request forms, device information, and documentation of approvals. OMETA assists manufacturers with the application process and certificate issuance.

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    Japanese medical device manufacturers must obtain certificates from regulatory authorities to export devices to certain countries. These certificates confirm that devices were manufactured according to Japanese law. Manufacturers submit applications to OMETA, an organization that checks applications for validity and forwards them to the appropriate regulatory division. Applications must include request forms, device information, and documentation of approvals. OMETA assists manufacturers with the application process and certificate issuance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    54 views2 pages

    Issuance of Certificates For Medical Devices For Export: (1) Where Applications Should Be Submitted

    Uploaded by

    Manas Mishra
    Japanese medical device manufacturers must obtain certificates from regulatory authorities to export devices to certain countries. These certificates confirm that devices were manufactured according to Japanese law. Manufacturers submit applications to OMETA, an organization that checks applications for validity and forwards them to the appropriate regulatory division. Applications must include request forms, device information, and documentation of approvals. OMETA assists manufacturers with the application process and certificate issuance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 2

    Issuance of Certificates for Medical Devices for Export

    When Japanese medical device manufacturers intend to export their products to foreign countries,
    certain countries require the manufacturers to submit the regulatory authority-issued certificate
    which authenticates that the products were manufactured in accordance with the Pharmaceutical
    Affairs Act (Act No. 145 of 1960).

    Those certificates are to be issued as specified in the “Issuance of Certificates of Drugs, etc. for
    Export,” the Administrative Notice jointly issued by the Evaluation and Licensing Division, Office
    of Medical Devices Evaluation and Safety Division of Pharmaceutical and Food Safety Bureau,
    Ministry of Health, Labour and Welfare (MHLW), dated October 3, 2005.

    (1) Where Applications Should be Submitted

    A medical device manufacturer who intends to obtain a certificate for medical devices
    (hereinafter referred to as "applicant") is required to submit the application form for certificates
    for medical devices and the form of a certificate pre-completed by the applicant, by delivering in
    person or by mail, to the Overseas Medical Equipment Technical Assistants (OMETA).
    OMETA checks the validity of the information provided in the certificate form before
    forwarding the forms (with OMETA’s seal of confirmation affixed) to the relevant division or
    office according to the certificate category. OMETA charges a commission for the validity check
    of application documents.

    Overseas Medical Equipment Technical Assistants (OMETA)


    Address: Room No.173, 7F, Daiichi-Nishiwaki Bldg.,
    1-58-10 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
    Phone: 03 3372 1793
    Fax: 03 3372 1797
    E-mail: [email protected]
    Website: http://www.ometa.or.jp

    [Flow of Certificate Issuance]

    Contact for application


    Apply
    Marketing - Office of Medical Devices Evaluation, Evaluation
    authorization OMETA and Licensing Division
    holder Issue or
    or - Safety Division
    Manufacturer [Pharmaceutical and Food Safety Bureau, MHLW]
    (2) Documents to be submitted
    (a) Request form for the validity check of the certificate(s) to be issued by MHLW
    (OMETA-designated form)························································································· 1 copy
    (b) Application form for Certificates for Medical Devices (addressed to the
    Director of Office of Medical Devices Evaluation or Safety Division) ····················· 1 copy
    (c) Certificate form(s) (in English) ························ necessary number of copies + 1 extra copy
    Certificate form (in Japanese) ····················································································· 1 copy
    (d) Attachments
     A copy of License for Marketing Authorization Holder
     A copy of Manufacturer’s License
     A set of copies of Notification of Manufacturing or Importing Medical Devices
    for Export
     A set of copies of product approval documents or product certificates (including copies
    of documents for approval or certification for partial changes, if applicable) or
    marketing notifications

    (3) Application Form for Certificates of Medical Devices


    Please refer to the OMETA website for more information. (Japanese only)

    (4) Certificates of Medical Devices


    Applicants should submit the necessary number of copies of the certificate forms (one copy for
    one country, in principle) plus one extra copy for MHLW’s record. Such a certificate form in
    English shall be accompanied by the corresponding Japanese certificate form.

    In case where an applicant intends to obtain certificates for two or more products to submit to a
    single foreign government, it is recommended, where possible, that all the relevant products be
    included in one certificate rather than preparing a certificate for each product.

    (5) Others
    Please refer to the OMETA website for more information. (Japanese only)

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