CDSCO

POST APPROVAL CHANGES

Get authorized agent support for all your post approval changes to In-Vitro Diagnostic Kits substance for already approved IVD manufacturing site


In-Vitro Diagnostic Kits
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    CliniExperts has a well-established position in the Indian Healthcare sector and holds a valid Wholesalers License. CliniExpert has an experienced team who will guide you through all the process needed in filling of the application for Post Approval Changes in IVDs. Being updated with the latest guidelines by the CDSCO, Cliniexperts team ensure a quick and one-shot approval.

    What Are POST APPROVAL CHANGES?


    An approval is needed by the CDSCO in case an importer or manufacturer makes changes in the approved IVD through post approval change application . Post Approval Changes are the changes made by the manufacturer or the importer in any of the following:

    • construction material;
    • design affecting its intended use, performance and stability of the medical device;
    • the intended use or indication for use;
    • the method of sterilization;
    • the approved Shelf life;
    • the name or address of,domestic or overseas manufacturer or its manufacturing site or Authorized agent (for import only);
    • label changes (excluding change in font size, font type, color, label design)
    • manufacturing process, equipment or testing which shall affect quality of the device;
    • primary packaging material;
    • design which shall not affect quality; indication for use, performance and stability of the medical device;
    • manufacturing process, equipment, or testing which shall not affect quality of the device;
    • packaging specifications excluding primary packaging material.

    Who Can Apply


    Manufacturers and importers can apply for the post-approval changes.

    Inclusions In Post Approval Change Service

    Post Approval Services include- pre-requisite services

    SUGAM registration

    Manufacturing license (MD-5, MD-6, MD- 9, MD-10)

    Import License (MD-15)

    Clients can also opt for assistance in the following forms:

    MD-16 Application for License to Import Medical Devices

    MD-23 Permission to conduct Clinical Investigation

    Essential Tips

     

    The essential thing to remember while applying for Post Approval Changes is that:

     

    Approval of change from any GHTF country.


    Import license or manufacturing license copy.


    Documents are as per the MDR 2017.

     

    Difficulties often faced by importers or manufacturers are related to:


    Rejection by the Licensing Authority in case of discrepancies in the documents.


    A product cannot be placed in the market without post-approval change permission from an authority.

    Expert Advise

    Cliniexperts advice its clients to follow these tips to prevent any hassle in obtaining the Post Approval Changes approval from CDSCO:

    Post approval for minor changes needs to be informed to authority within thirty days.

    Importers or manufacturers need to comply with safety and quality related requirements before and after the post-approval change.

    Comparison table must be submitted on the changes with reasons and justifications.

    Primary Service

    Wholesale License (Form 20B, 21B)

    Regulatory Body: SLA   Application Forms: Form 19

    CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.


    Who Can Apply

    The applicant who wishes to store, distribute and sale the drugs in wholesale cn apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university or competent person (CP). Further, arrange one person with same competency for it.

    Frequently Asked Questions

    What will be the time period for approval by CLA for the implementation of a major change?

    The time taken for approval by CLA for the implementation of a major change is around sixty days. In case CLA does not indicate approval or rejectionsuch change shall be deemed to have been approved by the license.

    Whether any change in labelling which is not among the details mentioned under Chapter- Labeling of medical devices (Rule 44) need to be notified? For e.g., if the label is universal for India and Philippines and there is change of manufacturing of license no. In the Philippines label part as per their local regulations, need to be notified?

    Label excluding change in font size, font type, colour, and label design is a major change as per Sixth Schedule and prior approval needs to be taken from CDSCO.

    Will change in authorized Agent of imported medical devices require a fresh License?

    Yes. Change in Indian agent will require a fresh License.

    What are considered to be the major changes in Post approval of IVD?

    The major Post approval changes of IVD include changes in labels, manufacturing process, equipment or testing and primary packaging which need prior approval from the competent authority.

    Will post-approval change notification approval requires submission of a fee?

    Fee is not required for post approval change notifications.

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