The post approval changes are the changes made to the Medical products which have received approval from the Central Drugs Standard Control Organisation (CDSCO). The changes of the medical device in India that results in the impact of the changes on the quality of approved products to have an adverse effect on identity, strength, quality, purity of the product as these factors may relate to the safety or effectiveness of the product. This post approval change has been implemented by CDSCO from the new rule of the Drugs and Cosmetic Rules for medical device registration in India.
The Post approval changes are the changes that are done by the manufactures when a specific change needs to be done by the manufacturer which is implemented until the product is marketable. The changes which say the specific changes that a company would like to implement during the lifecycle of the product. Such a stepwise approach that is done by our expect team to lead faster and efficient implementation of changes for the post approval changes by the Central Drugs Standard Control Organisation (CDSCO).
There are many reasons for making changes to the Medical products after the original regulatory approval is obtained. The Indian authorized importer or authorized agent shall inform such a change to CLA (central licensing Authority) within a period of forty five days in the event of any change in the constitution of the overseas manufacturer or authorized agent. The following are the two categories under which the changes have been done by CDSCO under the Drugs and Cosmetics Rules.
- Major change ‐ Substantial potential
- Minor Change‐ Minimal potential
1.Major Change:
Changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity of a biological product as these factors may relate to the safety or effectiveness of the product. Major changes, as per the Medical Device Rules 2017 India, require prior approval before the implementation for regulatory approval. The time period for implementation of any major changes takes 60 days. The following shall be considered as major changes.
-
Material of construction
-
Design which shall affect quality in respect of its specification, indication for use: performance and stability of the medical device in india:
-
The intended use or indication for use
-
The method of sterilization
-
The approved Shelf Life
-
Change in Name of Overseas Manufacturer Or Its Manufacturing Site (for import only)
-
Change in Address of Overseas Manufacturer Or Its Manufacturing Site (for import only)
-
Label excluding changes in font size, font type, color , label design
-
Manufacturing process, equipment or testing which shall affect quality of the device
-
Primary packaging material
-
Line Extension of Additional Model Numbers or Model Names
For medical device registration in India, any substantial changes such as these would necessitate obtaining medical device approval in India before proceeding.
2.Minor Change:
Changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, of the biological product as these factors may relate to the safety or effectiveness of the product. Minor changes don’t require prior approval before the implementation for regulatory approval. The following shall be considered as minor changes.
- Design which shall not affect quality in respect of its specification, indication for use, performance and stability of the medical device in India
-
In manufacturing process, equipment, or testing which shall not affect quality of the device.
-
Packaging specification excluding primary packaging material
-
Amendments / Corrections / Others
Time period for implementation of any minor changes don’t need prior approval after providing the licensee information from CLA(central Licensing Authority), so within a period of thirty days after the change been applied it becomes effective.
How to update these changes with the CDSCO?
To update post-approval changes with the CDSCO, the Indian authorized agent or authorized importer must follow these steps in order to get their changes updated as per the latest requirements. Manufacturers should follow the Medical Device Rules 2017 India for proper categorization and submission of changes, whether major or minor.
-
Prepare Documentation: Compile all required documents, including updated technical files and risk assessments, that detail the changes made to the Medical device registration in India.
-
Submit Application: File an application with the CDSCO, clearly identifying the changes as major or minor and include all supporting documentation.
-
Pay Fees: If applicable, pay the necessary processing fees as per the CDSCO’s fee schedule for medical device import license India.
-
Undergo Regulatory Review: The CDSCO will assess the application and supporting documents to verify compliance with regulatory standards.
-
Receive Updated Approval: Upon approval, the CDSCO will issue an amended license reflecting the approved changes.
-
Monitor Compliance: Monitor Compliance: The authorized importer must continuously monitor the implementation of changes and ensure ongoing compliance with regulatory requirements for medical device approval in India.
How Morulaa Healthtech can assist you in Post Approval Changes?
-
Morulaa consistently works hard with an in‐house regulatory team to conduct medical device registration, IVDs, cosmetic in India by following CDSCO (Indian FDA)
-
With all expertise, Knowledge Morulaa also assists in obtaining the Import license, test license to successfully import products into India, ensuring compliance with medical device registration in India and also works for all types of Post Approval Changes. As an authorized importer, Morulaa ensures seamless execution of regulatory tasks for its clients.
-
Contact us for all types of Medical device registration, cosmetics and IVD registration, Post approval changes registration in India