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:
The application can be made by a importer or manufacturer.
Manufacturing license (MD-5, MD-6, MD- 9, MD-10)
Import License (MD-15)
MD-16 Application for License to Import Medical Devices
MD-23 Permission to conduct Clinical Investigation
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.
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.
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.
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.
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.
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.
Yes. A fresh license is required in case of change in Indian agent in case of imported medical devices.
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.
No. The post-approval change notification does not require any fees.