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CDSCO Post Approval Changes
Introduction
A CDSCO Post Approval Change (PAC) is any modification to an already-licensed medical device or IVD — in its design, manufacturing process, packaging, labelling, or firm details — made after the device's manufacturing or import license has been granted. Under the Sixth Schedule of the Medical Devices Rules, 2017, changes are classified as either major (needing CDSCO's prior approval, with a 60-day implementation window) or minor (needing only notification, within 30 days of the change). Filing a change under the wrong category, or not filing it at all, can put your existing license at risk of suspension or cancellation.
What Is a CDSCO Post Approval Change (PAC)?
Once a medical device or IVD has a valid manufacturing or import license, things rarely stay exactly the same. Manufacturers update designs, switch packaging suppliers, tweak labels, move production lines, or change their authorized agent. Any such modification to an already-approved device is called a Post Approval Changes (PAC), and it's governed by the Sixth Schedule of the Medical Devices Rules, 2017.
PAC exists so that CDSCO can keep track of what's actually being manufactured or imported under a license, without forcing every small tweak through a brand-new licensing process. Depending on how significant the change is, it falls into one of two categories — major or minor — each with its own approval pathway and timeline.
How PAC differs from endorsement
Endorsement (Form MD-3, MD-7, MD-8, or MD-14, depending on your license type) is for adding a completely new device to your existing license. A Post Approval Change is for modifying something about a device you're already licensed for — its design, packaging, labelling, manufacturing process, or firm details. If you're adding a product, you need endorsement. If you're changing something about a product you already have approved, you need PAC.
Major vs Minor Post Approval Changes: What's the Difference?
The Sixth Schedule of the Medical Devices Rules, 2017 sorts every post-approval change into one of two buckets, based on whether it could affect the device's quality, safety, or performance:
| Category |
What It Means |
Action Required |
Implementation Timeline |
| Major change |
Affects the device's quality, specifications, indication for use, performance, or stability |
Prior approval from CDSCO required before implementing |
Can be implemented once approved, generally within 60 days of approval |
| Minor change |
Does not affect the device's quality, specifications, indication for use, performance, or stability |
Notification to CDSCO only — no prior approval needed |
Must be notified within 30 days of implementation |
Getting this classification right matters. Treating a major change as minor — and implementing it without prior approval — is one of the most common ways manufacturers put their existing license at risk.
Common Examples of Major and Minor Changes
| Type of Change |
Major (Prior Approval) |
Minor (Notification Only) |
| Device design |
Design changes affecting specifications, indication for use, performance, or stability |
Design changes that don't affect specifications, indication for use, performance, or stability |
| Manufacturing process/equipment/testing |
Changes that affect the quality of the device |
Changes that don't affect the quality of the device |
| Packaging |
Change in primary packaging material |
Packaging specification changes excluding primary packaging material |
| Labelling |
Substantive label changes affecting claims or safety information |
Font size, font type, colour, or label design changes only |
| Firm/agent details |
Change in Indian Authorized Agent for an imported device (may require a fresh license, not just PAC) |
Change in firm name or address, generally reportable as part of retention or PAC filing |
Why Filing PAC Correctly Matters
Keeps your manufacturing or import license accurate and legally defensible — CDSCO's records should always reflect what you're actually producing or importing.
Protects against enforcement risk — products can't legally remain on the market if a major change was implemented without the required prior approval.
Reduces the chance of license suspension or cancellation, which CDSCO can pursue if major changes are found to have bypassed the approval process.
Supports smoother retention filings later, since your retention application will ask you to list and confirm all changes and endorsements made since the license was issued.
Builds a clean compliance history, which matters for audits, notified body inspections, and any future licensing action.
Who Needs to File a Post Approval Change?
Manufacturers holding an MD-5 (Class A/B) or MD-9 (Class C/D) manufacturing license who are modifying an already-approved device's design, packaging, labelling, or manufacturing process.
Importers holding an MD-15 import license who are changing the device's packaging, labelling, or manufacturing details at the overseas manufacturing site.
Loan license holders (MD-6 or MD-10) making changes to a device manufactured under a borrowed facility arrangement.
Any license holder changing firm-level details — such as company name, registered address, or (for importers) the Indian Authorized Agent.
If you're introducing a completely new device rather than modifying an existing approved one, you'd file an endorsement application instead of a PAC.
Documents Required for a Post Approval Change Application
Documentation requirements vary depending on the nature of the change, but a PAC submission commonly includes:
Cover letter clearly describing the change being made and classifying it as major or minor.
Copy of the existing manufacturing or import license the change relates to.
Updated technical documentation reflecting the change — for example, a revised Device Master File section, updated Plant Master File details, or new labelling artwork.
Risk assessment or justification explaining why the change does or doesn't affect the device's quality, specifications, performance, or stability.
Updated Free Sale Certificate or Quality Management System documentation, where the change affects the manufacturing site or process (for import licenses).
For a change in Indian Authorized Agent: a fresh Power of Attorney and constitution details for the new agent, since this typically triggers a licensing change rather than a simple notification.
Any other supporting documents CDSCO or the State Licensing Authority requests for the specific change being reported.
Step-by-Step Process: Filing a Post Approval Change
Identify exactly what's changing — design, manufacturing process, packaging, labelling, or firm/agent details — and gather the relevant technical documentation.
Classify the change as major or minor against the Sixth Schedule criteria: does it affect the device's quality, specifications, indication for use, performance, or stability?
For a major change: prepare a prior-approval application with updated technical documentation and a risk justification, and submit it to CDSCO/the concerned licensing authority through the SUGAM portal before implementing the change.
For a minor change: implement the change, then submit the required notification to CDSCO/the concerned licensing authority within 30 days.
Respond promptly to any query or deficiency memo raised during CDSCO's review.
For major changes, wait for formal approval before implementing — commercial rollout of an unapproved major change is a compliance risk.
Keep a copy of the approval or notification acknowledgment; you'll need it when it's time to file your license's retention application, since retention checklists require a list of endorsements and changes made.
CDSCO Post Approval Change Fees
Post-approval change notifications for minor changes are commonly described as not requiring a separate government fee. For major changes requiring prior approval, fee requirements can depend on the nature and scope of the change and the device's risk classification.
Verify before you file
Fee treatment for post-approval changes isn't as uniformly documented as fresh license or endorsement fees. Since this can vary by change type, device class, and any recent Second Schedule updates, confirm directly with CDSCO or your licensing authority via the SUGAM portal whether your specific change attracts a fee before submitting.
CDSCO Post Approval Change Timeline at a Glance
| Stage |
Major Change |
Minor Change |
| Documentation preparation |
Varies by complexity of the change |
Varies by complexity of the change |
| Filing window |
Before implementation — prior approval required |
Within 30 days of implementation |
| CDSCO review |
Reviewed and either approved or queried |
Acknowledged as notification; commonly cited as taking 2-4 weeks for straightforward changes |
| Implementation |
Only after approval is granted, generally within 60 days of that approval |
Can be implemented before notification is filed, but must be notified within 30 days |
Why Choose Silvereye Certifications For Getting Your CDSCO Post Approval Changes
The biggest risk in the CDSCO post-approval change process isn't the paperwork — it's misjudging whether a change is major or minor. Getting that classification wrong, and implementing a significant change without prior approval, is the single most common way manufacturers and importers put an otherwise good-standing license at risk. A clear, well-documented risk justification for every change is what keeps CDSCO's review straightforward and your license compliant.
Silvereye Certifications supports medical device manufacturers and importers with end-to-end post-approval change management — from correctly classifying each change under the Sixth Schedule, to preparing technical documentation and risk justifications, filing through the SUGAM portal, and keeping a clean change history ready for your next retention filing.
Next step
Planning a change to your medical device's design, packaging, labelling, or manufacturing process? Talk to Silvereye Certifications for a classification review and end-to-end post-approval change filing support before you implement it.
Frequently Asked Questions: CDSCO Post Approval Changes
It's any modification to an already-licensed medical device or IVD — such as a change in design, manufacturing process, packaging, or labelling — made after the device's license was granted, governed by the Sixth Schedule of the Medical Devices Rules, 2017.
A major change affects the device's quality, specifications, indication for use, performance, or stability, and needs CDSCO's prior approval before implementation. A minor change doesn't affect these factors and only needs to be notified to CDSCO within 30 days of implementation.
Endorsement adds a completely new device to your existing license. A Post Approval Change modifies something about a device you're already licensed for, like its design, packaging, labelling, or manufacturing process.
It depends on what's changing. A change to the primary packaging material is treated as a major change requiring prior approval. Other packaging specification changes, excluding the primary packaging material, are generally treated as minor and only need notification.
Label changes limited to font size, font type, colour, or label design are commonly treated as minor changes needing only notification. More substantive label changes — ones affecting claims, indications, or safety information — are typically treated as major changes needing prior approval.
This is treated as a serious compliance lapse. CDSCO can raise objections, and in some cases this can put your existing license at risk of suspension or cancellation, along with the product being ineligible for continued marketing until the change is properly approved.
Minor change notifications are commonly cited as taking around 2 to 4 weeks for straightforward cases. Major changes requiring prior approval can take longer, since CDSCO reviews the full technical justification before granting approval, generally with a 60-day implementation window once approved.
Minor change notifications are commonly described as not requiring a separate government fee. Fee treatment for major changes can vary by the nature of the change and device classification — confirm directly with CDSCO or the SUGAM portal for your specific change.
It's a special case. A change in Indian Authorized Agent for an imported device is often treated as requiring a fresh licensing action rather than a routine PAC notification, since it involves updated Power of Attorney and constitution documents for the new agent.
Yes. Minor changes don't require prior approval, so they can generally be implemented first — but you must notify CDSCO within 30 days of implementation to stay compliant.
