Once a medical device has received a manufacturing or import licence in India, the licence holder cannot freely modify the approved device, manufacturing process, labelling, packaging, or other regulated particulars without assessing the change under the Medical Devices Rules, 2017 (MDR 2017).
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices and in-vitro diagnostic medical devices (IVDs) in India. Post-Approval Changes (PACs) are specifically addressed under the Sixth Schedule of MDR 2017, which distinguishes between major changes requiring regulatory approval and minor changes that require notification after implementation.
For manufacturers and importers, proper post-approval change management is essential to maintain regulatory compliance, product quality, patient safety and continued market access in India.
The Medical Devices Rules, 2017 were issued under the Drugs and Cosmetics Act, 1940 and establish India's regulatory framework for medical devices and IVDs.
The principal provisions governing post-approval changes include:
The Sixth Schedule is particularly important because it specifies which changes are considered major changes and which are considered minor changes.
CDSCO's FAQs also confirm that major post-approval changes require approval from the applicable Licensing Authority before implementation, whereas minor changes can be implemented without prior approval but must subsequently be notified.
A Post-Approval Change (PAC) is a modification made to an already licensed or approved medical device, its manufacturing process, packaging, labelling, manufacturing site or other approved particulars.
Before implementing a proposed change, the licence holder should conduct a documented change assessment to determine:
This assessment should form part of the manufacturer's controlled QMS change-control process.
The Sixth Schedule of MDR 2017 expressly categorises specified changes as major or minor.
The following are specified as major changes under the Sixth Schedule:
A change in the material of construction of the medical device is considered a major change.
Such a change can potentially affect biocompatibility, mechanical properties, chemical characteristics, performance, stability or safety.
A design change is major when it affects the quality of the device with respect to:
Any change to the intended use or indication for use is a major change and requires regulatory approval before implementation.
CDSCO specifically confirms that expansion or modification of the approved indications/intended use is considered a major post-approval change.
Changing the method of sterilisation is a major change because sterilisation can directly affect the safety and microbiological quality of a medical device.
A change to the approved shelf life is classified as a major change.
Appropriate stability data and supporting validation should therefore be considered as part of the change assessment.
Major changes include changes in the name or address of:
The Sixth Schedule expressly identifies these changes as major.
Changes to the label are generally major, except changes involving:
The distinction is important because not every cosmetic label modification is automatically a major PAC.
A change in:
is major where the change affects the quality of the device.
A change in the primary packaging material is a major change.
This is particularly important for sterile devices or devices where packaging integrity can affect shelf life, sterility, product protection or performance.
The Sixth Schedule identifies the following as minor changes:
A design change is minor where it does not affect quality with respect to:
Changes to the manufacturing process, equipment or testing are minor where they do not affect the quality of the device.
Changes to packaging specifications, excluding changes to the primary packaging material, are classified as minor changes.
Unlike major changes, minor changes do not require prior approval. However, the licence holder must still comply with the applicable notification requirement.
CDSCO's medical-device FAQ states that minor changes should be informed to the CLA within 30 days after the change takes place or becomes effective.
The applicable timeline depends on whether the change relates to manufacturing or import.
|
Change |
Regulatory treatment |
Timeline |
|
Major manufacturing change |
Approval required |
45 days |
|
Major import change |
Approval required |
60 days |
|
Minor change |
No prior approval |
Notify within 30 days |
CDSCO's FAQ on medical-device software and post-approval changes confirms the 45-day timeline for manufacturing and 60-day timeline for import, while minor changes do not require prior approval but must be notified within 30 days.
For import licences, CDSCO's FAQ also addresses implementation after the 60-day period where no response has been received.
Important: The concept should not simply be described as an unconditional “automatic approval” for every PAC. Licence holders should follow the applicable MDR 2017 provisions and current CDSCO instructions and maintain complete evidence of the submission and regulatory timeline.
A Post-Approval Change application should be prepared carefully based on the nature and impact of the proposed modification.
A typical process includes:
Access the applicable CDSCO medical-device online system using the credentials associated with the relevant licence.
Assess the proposed modification against the Sixth Schedule and determine whether it is:
Document the impact of the proposed change on:
Depending on the change, appropriate verification, validation, stability studies, process validation, software validation or other technical assessments may be required.
The submission package may include, as applicable:
The exact documents should be determined according to the proposed change and the applicable CDSCO portal requirements rather than relying on a single generic checklist.
Submit the application through the applicable CDSCO online post-approval change system/portal and pay any applicable regulatory fee.
CDSCO or the applicable Licensing Authority may raise queries or request additional information.
The licence holder should respond within the prescribed timeframe and retain complete records of all correspondence.
Medical device software requires particular attention because software versions may change throughout the device lifecycle.
CDSCO's FAQ specifically states that for changes in the version of approved software, the importer/manufacturer should submit an application through the Post Approval Change in Medical Devices Online portal.
Software changes should therefore be assessed through the applicable PAC process rather than assuming that every software update is automatically minor.
The assessment should consider the effect of the update on:
The regulatory classification should be based on the applicable MDR 2017 requirements and CDSCO's current requirements rather than simply labelling an update as “major” or “minor” based on its version number.
A robust Quality Management System (QMS) is essential for effective post-approval change management.
Before implementing a change, manufacturers should establish a documented procedure covering:
The change should remain fully traceable from the original approved configuration to the revised configuration.
This is particularly important where the change affects the Device Master File, Plant Master File, risk-management documentation, labelling, IFU, manufacturing process or specifications.
A change in constitution should not be treated as an ordinary major or minor PAC.
CDSCO's FAQ specifically states that a fresh import licence application is required in case of change of constitution.
The FAQ also distinguishes constitution changes from other changes involving the name or address of manufacturers or authorised agents.
Therefore, before processing a corporate restructuring, merger, acquisition, ownership change or other constitutional change, the licence holder should determine whether the proposed transaction falls within the regulatory definition of change in constitution and whether a fresh licence application is required.
A few practical principles should be kept in mind:
Do Not Implement a Major Change Before the Applicable Regulatory Requirement Is Met
For a major post-approval change, the licence holder should follow the applicable approval mechanism and timeline before implementing the change.
Every change should have a documented:
The label, IFU, Device Master File, specifications, risk-management documentation and other affected records should remain consistent with the approved configuration.
The Sixth Schedule specifically distinguishes design changes that affect quality from those that do not.
A primary packaging material change is major, whereas certain other packaging-specification changes are classified as minor under the Sixth Schedule.
Effective CDSCO post-approval change management is not merely an administrative requirement.
It helps ensure that modifications to a licensed medical device do not unintentionally compromise:
For manufacturers and importers, a properly controlled PAC process also reduces the risk of regulatory observations and helps maintain continued market access in India.
CDSCO itself identifies post-approval changes in respect of medical devices as part of its Medical Devices Division activities.
Managing a medical device post-approval change requires more than submitting an online application. The proposed modification first needs to be correctly assessed against the Medical Devices Rules, 2017 and the Sixth Schedule.
MDR Consultants can support medical device manufacturers and importers with:
Whether the proposed modification involves a medical device design change, material change, manufacturing process, sterilisation method, packaging, labelling, shelf life, manufacturing site or software version, the change should be evaluated against the applicable MDR 2017 requirements before implementation.
Proper post-approval change management helps manufacturers remain compliant with CDSCO requirements while maintaining the safety, quality and performance of their medical devices in India.
Last Updated : 09 Sep 2026
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