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Pre-Conception & Pre-Natal Diagnostic Techniques in India - Form-A & Form-B


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    Pre-Conception & Pre-Natal Diagnostic Techniques – Overview

    As per the PC and PNDT act, 1994, every importer, manufacturer, retailer, distributor, dealer, and technician involved in buyback, sale, or repair of ultrasonography/Imaging machines has to apply Form A to the PC and PNDT authority, for obtaining preconception & prenatal diagnostic techniques certificate. The application needs to be submitted in person or by post at the Directorate of family welfare, Govt. of NCT of New Delhi. The receipt for the acknowledgment of the application is served by the authorized authority immediately (if an application is filed at the office) or by the end of the next working day in case of the post. If satisfied, after scrutinizing the application, PC and PNDT authority passes on the application to the Advisory PNDT Act, 1994 Amendments committee for its reviews and suggestions. A certificate of registration is granted to the applicant by the authorized authority in consultation with the advisory committee.

    PC-PNDT

    Who Can Apply?

    This form is to be filed by every importer, manufacturer, retailer, distributor, dealer, and technician involved in buyback, sale, or repair of ultrasonography/Imaging machine.

    How To Apply?

    The Applicant must follow the following process:

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      The application should be made in hard copy either in person or by post.

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      The application needs to be submitted in person or by post at the Directorate of family welfare, Govt. of NCT of New Delhi.

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      The receipt for the acknowledgment of the application is served by the authorized authority If satisfied a certificate of registration is granted to the applicant by the authorized authority in consultation with the advisory committee.

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    Validity

    The license is valid for five years.

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    Fee Involved

    There is no statutory fees charged by the government.

    Important Documents

    Important Documents

    The documents required for obtaining the certificate are -

     
    • Ownership document of the entity (whether individual, partnership firm or any other).
    • A copy of articles of association along with the details of the people of management needs to be submitted.
    • Description of the type of service/product is required to be furnished.

    Timeline to get Form-B from Central Drugs Standard Control Organisation

    40 to 45

    WORKING DAYS

    Essential Tips

    • The application for the PNDT certificate is to be made in compliance with the registration procedure specified in Form A along with the prescribed fee. The signature and stamp of the applicant must be duly affixed.
    • There is no exclusive document list provided under the act thus the authority can ask for further information as and when required.
    Expert Advise

    All the charts, records, forms, consent letters, and other allied documents along with one copy of the certificate of registration must be kept open for inspection by the authorized authority for two years or as prescribed by the act.

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    Frequently Asked Questions

    Can I transfer the registration certificate?

    No this registration certificate is not transferable.

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    Will I receive any feedback from the regulatory authority in case my application is rejected?

    The applicant is informed about the approval or rejection of the application as specified in Form B or C or as the case may be, within 90 days of receiving the application for registration.

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    When can I submit the application for renewing the registration certificate?

    The applicant needs to file Form A in duplicate for renewal of registration, 30 days before the expiry of the certificate of registration.

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    Is it possible to preserve the records in electronic mode?

    If the records are maintained electronically, a printed copy of the same must be kept in the safe custody of the authorized officer.

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    Is there any website where I can access the list of registered manufacturers/distributors/refurbishers/retailers/importers etc.?

    Yes, the list of registered manufacturers/distributors/ refurbishers/retailers/importers can be accessed on the following website http://web.delhi.gov.in/wps/wcm/connect/DoIT\_Healthvi/health/home/pc+pndt+act

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