If you hold an MD-9 manufacturing licence or an MD-15 import licence in India, your licence is issued in perpetuity, but only if you pay the prescribed retention fee every five years and continue to meet the licence conditions. Miss the deadline, and the licence can lapse.
CDSCO Licence Retention is therefore a recurring compliance requirement, with the cycle tied to the base licence. This article covers the fee structure, process, grace period and key requirements.
What Is CDSCO Licence Retention?
CDSCO Licence Retention is the fee payment and documentation exercise that keeps a manufacturing or import medical device licence valid beyond the five-year mark from its original issue date. It isn’t optional and it isn’t automatic. The licence holder has to file for it and pay the applicable retention fee before the deadline.
This is different from a “renewal.” A conventional renewal usually implies the licence has an expiry date and a fresh review happens each cycle. CDSCO Licence Retention works differently. Because Medical Device Licence Renewal under CDSCO is really a retention mechanism, the licence itself doesn’t expire and get reissued. Rules 29(1) and 37 of the Medical Devices Rules, 2017 state that manufacturing and import licences “shall remain valid in perpetuity,” conditional on timely retention fee payment.
So when people search for CDSCO Medical Device Licence Renewal, what they usually need is retention, not a renewal application in the traditional sense and getting that distinction right matters, because the paperwork and the underlying legal logic aren’t the same.
Which CDSCO Medical Device Licences Require Retention?
CDSCO Medical Device Licence Retention applies most directly to two categories.
| Licence | What It Covers | Retention Clock Starts |
| MD-9 (Manufacturing) | Manufacture of medical devices in India | Date the MD-9 was first granted |
| MD-15 (Import) | Import of medical devices into India, by class |
Date the import licence (MD-15) was first issued
|
| Notified Body / Testing Lab registration | QMS audit / device testing certificates | Date the registration was first issued |
MD-14 is the application form used to apply for an import licence; the granted licence itself is issued in Form MD-15, and it is the MD-15 that carries the five-year retention obligation under Rule 37. Retention does not attach to MD-14 as a separate licence.
CDSCO has also confirmed that registration certificates for Notified Bodies and Medical Device Testing Laboratories carry a similar retention obligation, though the process and grace period for those differ slightly from manufacturing and import licences.
Not every licence type follows an identical procedure, so if your portfolio includes anything outside MD-9 or MD-15, it’s worth confirming the specific retention treatment rather than assuming it mirrors the manufacturing licence process.
CDSCO Licence Retention Timeline
The CDSCO Licence Retention Timeline begins from the date the base licence, whether MD-9 or MD-15, was originally issued, not from the date of the most recent endorsement.
Rule 37 and CDSCO’s published MD-15 retention checklist make this point directly. Endorsements added later, whether that’s an additional manufacturing site or an extra product, remain valid only as long as the base licence stays valid, and they don’t reset or create a separate five-year window. So if a company received its MD-9 in 2019 and added three new products through endorsements in 2021 and 2022, the retention filing for all of it comes due in 2024, on the base licence’s anniversary.
If the deadline is missed, a grace period applies, but it comes with a penalty and it isn’t the same length across licence types:
| Licence Type | Grace Window (Rules 13, 29, 37) | Late Penalty |
| MD-5 / MD-6 / MD-9 / MD-10 Manufacturing | 180 days (Rule 29(2)) | ~2% of retention fee per month |
| MD-15 Import | 90 days (Rule 37) | ~2% of retention fee per month |
| Notified Body / Testing Lab registration | 90 days (Rule 13(8)) | ~2% of retention fee per month |
These grace periods and penalty rates are set out directly in Rules 13(8), 29(2), and 37 of the Medical Devices Rules, 2017.
CDSCO Licence Retention Requirements
CDSCO publishes separate retention checklists for MD-9 (manufacturing) and MD-15 (import) licences, and the two differ in a few respects.
For MD-9 manufacturing licence retention, CDSCO’s published checklist calls for:
- A covering letter and duly signed retention form, with the fee challan
- A copy of the existing licence (or its last retention) and copies of all endorsements
- A list of any devices deleted from the licence, with reasons
- A detailed fee breakup by site, device risk class, and device grouping
- An undertaking confirming no change in the firm’s constitution
- An undertaking confirming no major change in the Device Master File (DMF) and Plant Master File (PMF)
- Details of the qualification and responsibilities of current technical staff
For MD-15 import licence retention, the checklist adds a few items specific to import, including:
- An undertaking of no major DMF/PMF change, plus post-marketing surveillance/vigilance data covering the last five years (complaints, CAPA)
- Current Free Sale Certificate/Marketing Authorization documentation and a Quality Management System certificate
- Confirmation there’s no change to the Power of Attorney or the Authorized Agent arrangement (or a fresh POA if there is)
- An undertaking to pay the requisite fee for all products endorsed on the base licence before the five-year date
Not every retention application will need every item. It depends on what’s changed since the last filing, and CDSCO can update these checklists. Confirm the current version published on the CDSCO website for your specific licence type before assembling documents.
CDSCO Licence Retention Process
Step 1: Identify the base licence and retention date.
Every manufacturer should keep a central record of the licence number, licence type, original issue date, the resulting retention due date and every endorsement linked to it, including products and manufacturing sites.
Step 2: Review the existing licence.
Before filing, check that the products, models, sites, and manufacturer or agent information on record still match reality.
Step 3: Review current compliance status.
Retention shouldn’t be treated as separate from everything else that’s happened since the last filing. If products, sites, labelling or the Authorized Agent have changed, that needs to be reflected.
Step 4: Prepare the required documentation.
Assemble whatever the applicable retention procedure calls for, based on licence type and current CDSCO guidance.
Step 5: Calculate the applicable retention fee.
Work this out against the current official fee schedule, not last cycle’s figures.
Step 6: Submit through the applicable CDSCO system.
Retention applications are filed through CDSCO’s online systems; the specific workflow should be confirmed against current SUGAM portal guidance at the time of filing.
Step 7: Monitor the application.
Track status and respond promptly to any communication from CDSCO.
Step 8: Respond to queries, if any.
Keep responses consistent with what was originally filed and with the supporting documentation.
Step 9: Maintain evidence of retention.
Hold onto submission records, payment receipts and the approval or acknowledgement once it comes through, alongside an updated licence record.
CDSCO Retention Fee and Medical Device Licence Retention Fees
The CDSCO Retention Fee is set out in the Second Schedule of the Medical Devices Rules, 2017, and it scales with device class. Fees are charged per product and per manufacturing site, and they increase from Class A through Class D. Class D device attracts a materially higher fee than a Class A device, and a manufacturer with multiple sites pays the site-level component for each one.
| Component | Class A/B | Class C/D |
| Import retention, per site | ~$1,000-2,000 | ~$3,000 |
| Import retention, per device | ~$50-1,000 | ~$500-1,500 |
Confirm the budgeting against the live CDSCO fee schedule for specific device class, site count and licence type.
CDSCO Licence Grace Period
A CDSCO Licence Grace Period does exist. Under Rule 29(2) of the Medical Devices Rules, 2017, manufacturing licences (MD-5, MD-6, MD-9, MD-10) carry a grace window of 180 days after the five-year retention date, with a late fee of 2% of the retention fee per month during that window. Under Rule 37, import licences (MD-15) carry a shorter grace window of 90 days, with a late fee of 2% per month. Under Rule 13(8), registration certificates for Notified Bodies and testing laboratories also carry a 90-day grace period. Check CDSCO’s circulars archive for any updates to these figures.
Because endorsements are only valid as long as the base licence is valid, a lapse doesn’t stay contained to one product. It can affect every linked model and site endorsement riding on that base licence. Regardless of licence type, once the grace period runs out without payment, CDSCO Licence Suspension or cancellation follows, and reinstatement is not automatic.
CDSCO Manufacturing Licence Retention
For CDSCO Manufacturing Licence Retention, the MD-9 licence is the base document. Approved products, manufacturing site details and any endorsements added over time all come up together on the same five-year cycle. The retention filing needs to reflect an accurate product portfolio and current ISO 13485 certification status where applicable.
Multi-product and multi-site manufacturers should expect a heavier retention exercise than a single-product manufacturer at a single site, simply because there’s more to document and more fee components to calculate.
CDSCO Import Licence Retention
CDSCO Import Licence Retention applies to the MD-15 import licence, obtained via an MD-14 application. The retention obligation under Rule 37 attaches to the granted MD-15 licence, not to the MD-14 application itself. In practice, the Indian Authorized Agent typically manages the local retention filing on behalf of the overseas manufacturer, since the Agent is the entity with direct standing before CDSCO.
But the manufacturer still needs to supply the underlying product and sales data the Agent will submit, keep the Agent updated on any product or site changes, and confirm the fee is paid and the filing acknowledged. Foreign manufacturers relying on a distant Agent relationship should not treat this as something to check on only once every five years.
Common Problems Manufacturers Face With CDSCO Licence Retention
Losing track of the five-year date. Five years is long enough for regulatory affairs staff to change roles and for institutional memory of the original filing to fade. It’s common for the person who handled the initial licence application to have moved on by the time retention comes due.
Underestimating documentation requirements. Retention often gets planned as “pay a fee.” The documentation lift, particularly assembling current sales data and confirming certification status, tends to surprise manufacturers who didn’t budget time for it.
Portfolio complexity. Products added through later endorsements are still tied to the original base licence’s retention cycle. Manufacturers who don’t map this centrally often discover the true scope of a filing later than they should.
Reliance on an external Indian Authorized Agent. For import licences, a thin or under-resourced Agent relationship is often where retention deadlines quietly slip.
Treating retention as purely administrative. Because retention doesn’t involve a technical review the way a change application does, it’s easy to under-resource. But a lapsed licence carries real commercial consequences, from suspended market access to disrupted supply commitments.
CDSCO Licence Retention and ISO 13485 Certification
ISO 13485 certification status is explicitly part of CDSCO’s published retention checklist for MD-15 import licences, which calls for a current Quality Management System certificate alongside other documentation.
For MD-9 manufacturing licence retention, CDSCO’s published checklist doesn’t list a QMS/ISO 13485 certificate as a named item. It focuses instead on DMF/PMF no-change undertakings and technical staff qualifications, though manufacturers should still keep certification current and consistent with what’s on file, since CDSCO can request it as part of “any other additional documents.”
What matters practically is that whatever certification status is on record with CDSCO matches the manufacturer’s current, valid certificate, including scope and expiry date, at the time of filing. If certification has lapsed, changed certifying bodies or been re-scoped since the last retention cycle, that needs to be reconciled before submission.
Role of a Regulatory Consultant in CDSCO Licence Retention
A consultant’s value here tends to concentrate in a few areas:
- Deadline tracking across a full licence portfolio, maintained as a live register rather than reconstructed from memory when a deadline approaches
- Documentation preparation: assembling sales data, certifications, declarations and supporting documents ahead of the filing window, so retention becomes a scheduled task instead of a scramble against the grace period.
- Fee planning across multiple products and sites, so cost is budgeted rather than a surprise
- Local coordination: a consistent point of contact for manufacturers based outside India, so retention doesn’t depend entirely on the continuity of one distributor or Agent relationship
Conclusion
CDSCO Licence Retention is a recurring compliance responsibility tied to the base licence, not an administrative afterthought that shows up once and gets forgotten. Manufacturers who track licence dates, linked endorsements, documentation and fee exposure centrally are in a far better position to file on time than those relying on one person to remember a date five years out.
If you need support with CDSCO licence retention, retention fee assessment, documentation preparation, licence compliance or ongoing medical device regulatory management in India, reach out to the experts at info@artixio.com for guidance tailored to your products and CDSCO licence portfolio.
FAQs
Q1. What is CDSCO Licence Retention?
It’s the fee payment and documentation filing required every five years to keep a CDSCO manufacturing or import medical device licence valid beyond its original issue date.
Q2. Is CDSCO licence retention the same as licence renewal?
Not exactly. CDSCO licences don’t expire and get reissued the way a conventional renewal implies. They’re issued in perpetuity, conditional on the retention fee being paid on time. Retention is the mechanism that keeps the licence alive, rather than a fresh application.
Q3. What is the CDSCO Retention Fee?
It’s the fee charged under the Second Schedule of the Medical Devices Rules, 2017, calculated per product and per manufacturing site, and it increases with device class. Confirm exact figures against the current CDSCO fee schedule.
Q4. What documents are required for CDSCO Licence Retention?
CDSCO’s published checklists differ by licence type. MD-9 retention calls for the retention form, fee challan, existing licence and endorsement copies, a fee breakup by site/class, and no-change undertakings on the firm’s constitution and DMF/PMF. MD-15 import retention adds five years of post-marketing surveillance data, a Quality Management System certificate and confirmation of no change to the Power of Attorney. Confirm the current checklist on CDSCO’s website for your specific licence before filing.
Q5. Is there a CDSCO Licence Grace Period?
Yes. Under Rules 29(2), 37, and 13(8) of the Medical Devices Rules, 2017 manufacturing licences (MD-9 and related forms) get 180 days, import licences (MD-15) get 90 days, and Notified Body/Testing Lab registration certificates get 90 days, each with a 2% per month (or per mensem) late fee.
Q6. What happens if CDSCO licence retention is missed?
A late payment penalty applies during the grace period. Beyond it, the licence risks suspension or cancellation, and every endorsement linked to the base licence is affected along with it.
