facebook tracking

Registration For Non-Notified In Vitro Diagnostic in India


ENQUIRE NOW


    CliniExpert-usp test license

    CliniExperts holds a valid Drug Wholesale License and provides 360-degree regulatory solutions to importers and manufacturers of IVDs and other medical devices to launch their products in the Indian market. The professional team at CliniExperts will guide you through all the paperwork and help acquire speedy approvals to enable a timely and successful launch of your product.

    Registration For Non-Notified In Vitro Diagnostic – Overview

    The Central Drugs Standard Control Organisation (CDSCO) oversees all medical devices and their approvals in India. All non-notified In-vitro Diagnostic (IVD) medical devices need registration with the CDSCO. This excludes those already under the notified category of medical devices.

    Any Indian manufacturer or foreign importer of non-notified in-vitro diagnostics can use this service. They can apply for a registration number through this service.

    The applicant must apply for registration through the identified online portal, SUGAM. It is maintained by the Ministry of Health and Family Welfare.
    Registration No

    Who Can Apply?

    Any foreign importer or a local manufacturer who wishes to acquire a Registration Number of non-notified in-vitro diagnostics (IVDs) can apply for this service.

    Registration-Number-for-Non-Notified-.png

    How To Apply?

    The Applicant must follow the following process:

    The manufacturers and importers can apply through the following steps to obtain the Registration Number of non-notified IVDs.
    • icon

      Step 1: The applicant must visit the link:https://cdscomdonline.gov.in/NewMedDev/Homepage
    • icon

      Step 2: The applicant must register on the online portal by clicking on the registration link.
    • icon

      Step 3: The applicant should have a valid email-id and mobile number for registering on the portal.
    • icon

      Step 4: The applicants need to upload the following documents for registration on the portal:
      • Corporate Address Proof Details
      • Certificate of Incorporation
      • Copy of the Wholesale License and Manufacturing License (If the justification for the same is needed)
      • Undertaking Form
      • Identity Proof Details
    • icon

      Step 5: The applicant must complete the registration process verification. This is done using the four-digit OTP received on the registered mobile number. After verification, the applicant can log in and proceed with further procedures.
    • icon

      Step 6: Applicants must upload all relevant documents. It must be according to the Registration Number checklist.
    icon

    Validity

    The Registration number for the non-notified in-vitro diagnostics (IVDs) licenses has a validity period.

    • The license validity for Class A and B in-vitro diagnostic (IVDs) devices is till September 2022.
    • The license validity for Class C and D in-vitro diagnostic (IVDs) devices is till September 2023.
    icon

    Fee Involved

    The Government fee is not applicable for obtaining a Registration number for the non-notified in-vitro diagnostics (IVDs).

    Important Documents

    Important Documents

    The essential documents required for this voluntary registration are:

     
    • ISO 13485 Certificate
    • In case of import, a Free Sale Certificate from the country of origin
    • Device description including material of construction, intended use, shelf life, sterilization, dimension, component, or accessories
    • Other important documents regarding the device as mentioned on SUGAM portal

    Timeline to get from Central Drugs Standard Control Organisation

    The timeline for Registration Number is not specified by Government Body

    Essential Tips

    CliniExperts has some essential tips that might benefit their clients:

     
    • The applicant must have an ISO 13485 Certificate as a mandatory requirement for the application process. The applicant might face a problem if the product's regulatory status is unclear. Thus, the applicant must seek clarity from the authority before applying for the voluntary registration number. This step is essential.
    • If the Authority has not classified the product, the applicant must finalize the product classification. This step is necessary before proceeding.
    Expert Advise

    The importer and the manufacturers should act in accordance with the safety and quality-related requirements.

    Once the validity period of the Registration Number expires, the terms and conditions for the Import License and Manufacturing License are applicable.

    The importer and the manufacturers should act in accordance with the safety and quality-related requirements.

    Related Services

    navigate

    SUGAM Registration- MD/ IVD

    Importer | Regulatory Body: CDSCO

    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...

    Test license to manufacture In Vitro Diagnostics in India – MD 12 & MD 13

    Manufacturers | Regulatory Body: CDSCO

    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.

    Import License For In-Vitro Diagnostic Kits in India – Form MD14 & MD15

    Importers | Regulatory Body: CDSCO

    Get Your Import License for In-Vitro Diagnostic Kits (IVD) and Medical Devices with CliniExperts. Hassle-free assistance in providing Import License of Form MD 15.

    navigate

    Frequently Asked Questions

    Is the ISO 13485 Certificate a mandatory requirement for a manufacturer or importer?

    Yes. The ISO 13485 Certificate is a mandatory requirement for obtaining the Registration Number for the in-vitro diagnostic devices. Therefore, all the manufacturers or importers should have ISO 13485 Certificate before applying for this service.

    icon

    Who can file the application for a Registration Number?

    Any foreign importer or manufacturer in India can apply for a Voluntary Registration Number.

    icon

    Where can we find more information on the risk class of non-notified devices?

    To know more about the risk class of non-notified devices, you can refer to the CDSCO Classification List.

    icon