CDSCO

POST APPROVAL CHANGES

Get authorized agent support for all your post approval changes to Medical Device substance for already approved Medical Device manufacturing site


Medical Device
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    CliniExperts holds a valid Drug Wholesale License to import and export any medical device across countries. Expert professionals of CliniExpert are fully updated with the most recent guidelines and provide extensive support throughout the application filling process of post approval changes for the Medical Devices (MD).

    What Are POST APPROVAL CHANGES?


    Any importer or manufacturer of medical devices who makes changes must apply for Post-approval changes in the License to the CDSCO. This is applicable if the changes are done by the manufacturer or by the importer in any of the following aspects:

    • Material of construction;
    • Design such that it affects its indications of use; performance and stability of the medical device;
    • Indication for use or intended use
    • The method of sterilization
    • The approved shelf life
    • The name or address of the domestic/ overseas manufacturer or its manufacturing site; or Authorized agent (for import only)
    • Label (excluding change in font size, font type, color, label design)
    • Manufacturing process, equipment, or testing
    • Primary packaging material.
    • Design such that it doesn’t affect intended use or performance and stability of the medical device
    • In the manufacturing process, equipment, or testing of the device
    • In the packaging specifications excluding primary packaging material.

    Who Can Apply


    The application can be made by a importer or manufacturer.

    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

     

    CliniExperts team advices the following as a must before going for Post Approval Changes in the License:

     

    Approval of change from any GHTF country.


    Import license /manufacturing license copy.


    Documents as per the MDR 2017 requirement for post approval change.

     

    The most common difficulties faced by clients in obtaining the Post Approval Changes are as follows:


    The Licensing Authority might reject the application in case of discrepancies on the documents submitted on post approval change.


    Without prior approval of Major changes on the product CDSCO might cancel the license.


    Products are not allowed to place on the market without post approval change permission approved by the authority.

    Expert Advise

    CliniExperts advices that clients keep the following points in mind before applying for Post Approval Changes to ensure smooth approvals without rejection:

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

    Importer/Manufacturer needs to comply with all prescribed safety and quality 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 time-period for approval by CLA for implementation of a Major change?

    The time taken for the approval is sixty days. If CLA fails to indicate acceptance or rejection within sixty days, the changes are deemed to have been approved by the licensee.

    Whether any change in labeling 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?

    Yes. Prior approval needs to be taken from Central Drugs Standard Control Organization for labels excluding changes in font size, font type, colour, and label design is a major change as per Sixth Schedule.

    Will change in authorized Agent require fresh License?

    Yes. A fresh license is required in case of change in Indian agent in case of imported medical devices.

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

    Major changes such as changes in labels, manufacturing process, equipment or testing and primary packaging material are considered as major changes and need prior approvals from the competent authority.

    Will post-approval change notification require submission of fee?

    No. The post-approval change notification does not require any fees.

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