Getting a medical device license in India is one milestone. Keeping it valid is a completely different discipline — and one that a surprising number of licensed businesses manage poorly.
Under the Medical Device Rules (MDR), 2017, licenses issued by CDSCO do not carry traditional expiry dates. Your MD-15 import license or MD-9 manufacturing license does not automatically expire after 3 years or 5 years the way a passport does. But here is the catch that trips up thousands of businesses: your license is valid in perpetuity only as long as you pay the retention fee every 5 years and maintain ongoing compliance. Miss the retention fee, and your license enters suspension. Let it lapse further, and cancellation follows.
In May 2024, CDSCO issued a formal reminder circular to all medical device manufacturers, importers, and testing laboratories specifically about retention fee payment obligations — a clear signal that enforcement was being stepped up. As the first wave of MDR 2017 licenses approach their 5-year marks in 2026, the retention process is now a live and urgent concern for thousands of licensees across India.
This guide covers everything you need to know: when to start the retention process, what documents are required, what the fees are, and — critically — what happens if you miss the deadline.
CDSCO’s May 2024 circular stated explicitly: failure to pay the required retention fees will lead to suspension or cancellation of the license. All endorsements to a base license are also valid only till the validity of the base license. This is not a theoretical risk — it is an active enforcement priority for CDSCO in 2026.
Do Medical Device Licenses Expire in India?
This is the most common misconception among licensees — and the one that creates the most compliance risk.
The answer is nuanced: CDSCO medical device licenses do not have a fixed expiry date in the traditional sense. Your MD-15 import license or MD-9 manufacturing license, once granted, is described in MDR 2017 as valid in perpetuity — meaning it does not automatically expire after a set number of years.
However, this perpetual validity is conditional on two requirements being continuously met:
- Retention fee payment every 5 years — calculated from the date the base license was originally approved
- Ongoing compliance with all MDR 2017 requirements — including post-market surveillance, adverse event reporting, and document currency
If either condition is not met, CDSCO can suspend or cancel the license — effectively ending your ability to manufacture or import until the matter is rectified. In the worst case, you may be required to restart the application process entirely, with the full documentation burden and timeline that entails.
Important clarification from CDSCO (as per industry practice): the 5-year retention clock runs from the date of the base import license approval — not from the date of individual endorsements. If you have a base license issued in January 2021 with product endorsements added in 2023, the retention for all products falls due in January 2026 — not in 2028.
When Should You Start the Retention Process?
Waiting until the retention fee due date arrives is one of the most common and costly mistakes in medical device compliance management. Here is why: the retention process is not just a fee payment. It requires a complete document package — updated certificates, current FSC, post-market data, and a declaration on product changes. Gathering and verifying all of this takes time.
| 6 months before due date | Begin compliance audit — review all documents against CDSCO’s retention checklist. Identify any expired certificates, documentation gaps, or undeclared product changes. |
| 5 months before | Obtain fresh Free Sale Certificates from the manufacturer’s home country authority. This step often takes 4 to 8 weeks and cannot be rushed. |
| 4 months before | Renew or confirm ISO 13485 certification. Ensure surveillance audit is complete and certificate is valid through the retention submission date. |
| 3 months before | Compile post-market surveillance data, adverse event logs, product change declarations, and updated DMF/PMF where applicable. |
| 2 months before | Prepare the complete retention application package — Form + documents + declaration. Have it reviewed by a regulatory consultant before submission. |
| 1 month before | Submit the retention application on SUGAM portal. Pay the retention fee online. Obtain acknowledgement and retain proof of submission. |
| Due date | Retention fee must be paid ON or BEFORE this date. Even one day late triggers the 2% per month late fee. |
Starting 6 months in advance is not overcautious — it is industry best practice. The most common cause of retention problems is discovering an expired ISO 13485 certificate or an outstanding FSC when you are 30 days from the deadline, with no time to resolve it.
What Is the Retention Fee? — Amounts and Schedule
Instead of a traditional renewal, CDSCO operates a retention model. You pay a fee every 5 years to confirm your continued compliance and maintain the validity of your license. The fee is specified in the Second Schedule of MDR 2017 and applies to each manufacturing site and each product endorsed on the license.
| Device Class | Initial Application Fee | Retention Fee (5-Year) | Late Fee Rate |
| Class A | Rs. 5,000 per site | Rs. 5,000 per site + Rs. 500 per device | 2% of retention fee per month delayed |
| Class B | Rs. 50,000 per site | Rs. 50,000 per site + Rs. 2,500 per device | 2% of retention fee per month delayed |
| Class C | Rs. 1,50,000 per site | Rs. 1,50,000 per site + Rs. 7,500 per device | 2% of retention fee per month delayed |
| Class D | Rs. 2,50,000 per site | Rs. 2,50,000 per site + Rs. 12,500 per device | 2% of retention fee per month delayed |
Note: Fees shown are indicative based on MDR 2017 Second Schedule. Always verify the current fee schedule on the CDSCO website or through your regulatory consultant before submission, as fees are subject to revision.
The late fee calculation: if your retention fee is Rs. 2,50,000 for a Class D device site and you are 3 months late, the late fee is 2% x Rs. 2,50,000 x 3 months = Rs. 15,000. The total payable would be Rs. 2,65,000. For large portfolios with multiple sites and devices, late fees accumulate quickly.
Documents Required for License Retention
The retention process is not just a fee payment — it requires a complete, verified document package submitted through the SUGAM portal. CDSCO’s retention checklist mandates the following:
| Document | Key Requirements for Retention |
| Existing License Copy | Current MD-15 (import), MD-9 (Class C/D manufacturing), or MD-5 (Class A/B manufacturing) license — confirming the base license details and original approval date. |
| Free Sale Certificate (FSC) | Current FSC from the National Regulatory Authority of the country of manufacture. For import licenses: CDSCO may request Free Sale Certificates from reference countries (such as USA, EU, UK, Canada, Japan, Australia) or justification if not available. |
| ISO 13485 Certificate | Must be current and valid at the time of retention submission. Must cover the manufacturing site and device categories. An expired ISO 13485 certificate will cause the retention application to be queried or rejected — this is the most commonly overlooked document. |
| Updated Device Master File (DMF) | If any changes have been made to device design, materials, intended use, or manufacturing process during the 5-year period, the DMF must be updated to reflect the current status. If no changes were made, a signed declaration to this effect is required. |
| Updated Plant Master File (PMF) | For manufacturing licenses: current facility details, updated equipment list, process validation status, and GMP compliance evidence. For import licenses: current manufacturing site information matching the DMF. |
| Post-Market Surveillance Data | Complaint handling records, adverse event reports submitted to CDSCO, and trend analysis data for the 5-year period covered by the retention. CDSCO is increasingly scrutinising PMS data quality at retention submissions. |
| Declaration — No Product Changes | Signed declaration from the manufacturer/licensee that no changes have been made to the device or manufacturing process that were not previously notified to CDSCO. This is a key compliance commitment. |
| Product Change History (if applicable) | If changes were made and notified during the 5-year period — design changes, site changes, labeling amendments — documentation of all notified changes must accompany the retention application. |
| Sales Data Summary | Summary of quantities and values of the device sold or imported in India during the retention period — demonstrating active market presence and product monitoring. |
| Retention Fee Payment Receipt | Proof of online fee payment through the SUGAM portal. The fee must be paid before or at the time of document submission. |
Critical rule: The retention process does not allow you to make changes or add new products to your license. During retention, you must declare that no unapproved changes have been made. Any product additions or design changes must be handled through separate endorsement applications BEFORE the retention submission.
What Happens If You Miss the Retention Deadline?
This is where the consequences become serious and escalate progressively. Missing the retention fee deadline does not result in an immediate warning letter — CDSCO may initiate suspension or regulatory action if retention requirements are not fulfilled:
| Stage | What Happens |
| Day 1 after deadline | Retention fee is overdue. Late fee begins accruing at 2% of the original retention fee per month (or part of month). You can still pay and retain your license, but the longer you wait, the more you pay. |
| Continued non-payment | CDSCO may issue a show-cause notice to the licensee requiring explanation for non-compliance with retention obligations. |
| License Suspension | If retention remains unpaid and CDSCO determines the license is not being actively maintained, the license is suspended. During suspension: manufacturing, import, sale, and distribution of the device is illegal. All commercial activity stops. |
| License Cancellation | In cases of prolonged non-payment or non-response to CDSCO notices, the license may be formally cancelled. In many cases, cancellation may require filing a fresh application, depending on CDSCO’s decision and the nature of non-compliance. |
| Fresh Application Required | If the license is cancelled, you must restart the full application process: complete documentation (DMF, PMF, FSC, ISO certificate, test reports), full government fee, CDSCO review, and for manufacturing licenses, a new facility inspection. Timeline: 3 to 12 months depending on device class. |
| Business and Legal Impact | During any period of suspension or post-cancellation: customs will reject import consignments, e-commerce platforms will suspend listings, institutional buyers will cancel purchase orders, and CDSCO may notify state authorities and port health officers. Legal liability under the Drugs and Cosmetics Act, 1940 may arise for any sales made during suspension. |
Importers vs Manufacturers — Key Differences in Retention
The retention process has specific nuances depending on whether you hold an import license (MD-15) or a manufacturing license (MD-9/MD-5). Understanding these differences prevents avoidable gaps:
| Requirement | Importers (MD-15) | Manufacturers (MD-9/MD-5) |
| Retention Clock Start | Date of base import license (MD-15) approval — not individual endorsement dates | Date of manufacturing license (MD-9/MD-5) approval |
| Free Sale Certificate | Required — from country of manufacture. CDSCO may request Free Sale Certificates from reference countries (such as USA, EU, UK, Canada, Japan, Australia) or justification if not available. | Not applicable for domestic manufacturing |
| ISO 13485 Requirement | Certificate for foreign manufacturer’s site — must be current | Certificate for your own facility — must be current and cover all licensed device categories |
| Facility Inspection at Retention | Typically desk review only — unless CDSCO determines re-inspection is needed | CDSCO may conduct a re-inspection if significant concerns exist |
| Post-Market Surveillance Data | Complaint records, adverse events reported, India sales data | Manufacturing batch records, complaint handling, adverse events, process validation status |
| Declaration on Product Changes | Required — manufacturer declaration that device is unchanged or changes were notified | Required — facility and product change declaration |
| Endorsement Retention | All endorsements fall due at the same time as the base license — not separately | All devices on the manufacturing license renew together |
Common Mistakes That Create Retention Problems
1. Assuming the License Is Lifetime With No Conditions
The most widespread misconception. Many licensees receive their MD-15 or MD-9 and assume it is a permanent, unconditional approval. Five years later, they are surprised to find that their license has lapsed due to non-payment of the retention fee. The license is perpetual — but only with active maintenance.
2. Ignoring ISO 13485 Certificate Validity
ISO 13485 certificates from accredited Certification Bodies are typically valid for 3 years, with annual surveillance audits. A licensee whose ISO 13485 certificate lapsed during the 5-year license period cannot complete the retention process without first obtaining a fresh certificate. This can add 2 to 4 months to the retention timeline if not tracked proactively.
3. Missing Retention Deadlines Due to No Compliance Calendar
CDSCO does not proactively send reminder letters to licensees about upcoming retention deadlines. The responsibility is entirely on the licensee. Licensees must maintain their own compliance tracking system and should not rely on regulatory reminders.
4. Making Product Changes Without Notifying CDSCO
If you have made changes to your device’s design, materials, manufacturing process, or intended use during the 5-year period without notifying CDSCO, you cannot honestly sign the retention declaration. Undeclared changes discovered by CDSCO — through market surveillance or a subsequent audit — can result in license cancellation, not just retention delay.
5. Treating All Endorsements as Separately Renewable
Many importers with multiple product endorsements on their base license believe each endorsement renews independently. As per industry practice, all endorsements must be submitted for retention at the same time as the base license — 5 years from the base license issue date. Missing this creates a situation where some products are technically unprotected.
6. Leaving the FSC to the Last Minute
The Free Sale Certificate must be obtained fresh from the foreign manufacturer’s home country regulatory authority — a process that can take 4 to 8 weeks in many jurisdictions. Starting the retention process only 30 days before the deadline leaves no time to obtain a current FSC, resulting in a deficient submission that CDSCO cannot process.
Pro Tips to Stay Permanently Compliant
- Build a compliance calendar the day your license is issued — set retention reminders for 6 months, 3 months, and 1 month before the 5-year due date
- Track ISO 13485 certificate validity separately — set alerts for surveillance audit dates and re-certification deadlines
- Track FSC validity — Free Sale Certificates typically have a validity period in the issuing country. Know when yours expire and plan ahead
- Maintain a running post-market surveillance log throughout the license period — do not try to reconstruct 5 years of complaint data and adverse event records at renewal time
- Notify CDSCO of any device or site changes promptly during the license period — do not accumulate undeclared changes that create problems at retention
- Licensees should not rely on regulatory reminders and must maintain their own compliance tracking system.
- Work with a compliance consultant who manages your retention calendar alongside your initial registration — continuity of regulatory management prevents the gaps that cause retention failures
Frequently Asked Questions
Is medical device license renewal mandatory in India?
Yes — though it is called retention rather than renewal. Under MDR 2017, all CDSCO medical device import licenses (MD-15) and manufacturing licenses (MD-9, MD-5) must undergo a retention process every 5 years from the date of the base license approval. This involves submitting a retention application with updated documents and paying the prescribed retention fee. Failure to do so leads to license suspension and ultimately cancellation.
When exactly does the 5-year retention clock start?
The 5-year retention period starts from the date the base license was originally approved by CDSCO — not from the date of any subsequent endorsements added to the license. For example, if your base MD-15 import license was issued on 15 March 2021, the retention falls due on 15 March 2026 — regardless of when any additional product endorsements were added.
What is the late fee for missing the retention deadline?
The late fee is calculated at 2% of the original retention fee per month (or part of a month) of delay. For a Class D device with a retention fee of Rs. 2,50,000, a 1-month delay costs an additional Rs. 5,000. A 6-month delay costs Rs. 30,000 in late fees alone — on top of the original retention fee. The fee continues to accrue until payment is made or the license is cancelled.
Can I add new products during the retention process?
No. The retention process specifically does not allow for amendments, additions, or changes to the license. If you want to add new product endorsements or declare changes, these must be handled through separate endorsement applications filed with CDSCO before the retention submission. At retention, you submit a declaration that no unapproved changes have been made.
What happens to my import shipments if my license is suspended?
Immediately. Customs authorities at Indian ports of entry check license validity before allowing import consignments to clear. A suspended or cancelled license results in the shipment being held at the port, subject to demurrage and storage charges. The shipment cannot be released until the license issue is resolved — which may take weeks or months if the suspension is due to non-payment. In the meantime, your customers receive no goods and your commercial commitments are disrupted.
Do I need to submit post-market surveillance data at retention?
Yes. CDSCO’s retention checklist requires complaint handling records, any adverse events reported to CDSCO during the 5-year period, and a summary of sales data. CDSCO’s post-market surveillance requirements have been actively strengthened in 2025-26, and the quality of PMS documentation submitted at retention is receiving increased scrutiny. Businesses that have not maintained proper PMS records during the license period will find the retention process significantly more difficult.
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