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.
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.
The Applicant must follow the following process:
The application should be made in hard copy either in person or by post. |
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 If satisfied a certificate of registration is granted to the applicant by the authorized authority in consultation with the advisory committee. |
The license is valid for five years.
The documents required for obtaining the certificate are -
Form-Bfrom Central Drugs Standard Control Organisation
40 to 45
WORKING DAYSAll 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.
The registration process includes several steps to obtain approvals. The process involves registration, undertaking, and uploading the documents, complying with the given rules and regulations. We at CliniExperts, make sure that our expert team creates your registration easy and quick so that you can focus on more important aspects of your product launch...
Registration for in-vitro diagnostic medical devices for manufacturing can be time-consuming and tedious; we at CliniExperts will take care of all the registration procedures while you focus energies on planning your product launch. From the application process forms to undertaking a license test, we assist in every registration aspect to help you smoothly start the manufacturing process.
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No this registration certificate is not transferable.
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.
The applicant needs to file Form A in duplicate for renewal of registration, 30 days before the expiry of the certificate of registration.
If the records are maintained electronically, a printed copy of the same must be kept in the safe custody of the authorized officer.
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