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CDSCO Non Conviction Certificate Registration
Introduction
A CDSCO Non-Conviction Certificate (NCC) is an official document confirming that a licensed medical device manufacturer or importer has not been convicted, or had any regulatory action initiated against them, for adverse events, market complaints, or Not of Standard Quality (NSQ) reports on the applied products. It's most commonly required for government tenders, institutional bids, and some foreign regulatory submissions.
You must already hold a valid manufacturing or import license to apply. Applications are filed online through CDSCO's Medical Devices portal, and since April 2025, CDSCO issues NCCs through an auto-generated digital workflow, commonly valid for around 1 year.
What Is a CDSCO Non-Conviction Certificate (NCC)?
A Non-Conviction Certificate is a formal declaration, backed by CDSCO's own records, that a licensed medical device manufacturer or importer has not been convicted — and has had no regulatory action initiated against them — for adverse events, market complaints, or Not of Standard Quality (NSQ) reports relating to their licensed products in India. It's issued under CDSCO's own published guidance document for Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC), which governs both certificates together.
Hospitals, government procurement bodies, and institutional buyers frequently ask for an NCC as part of their tender or empanelment process, since it's a quick, CDSCO-backed way to confirm a supplier's compliance track record without each buyer having to independently verify it. Some manufacturers also use it to support regulatory submissions in other countries that ask for confirmation of a clean compliance history from the country of manufacture.
Conviction Certificate (NCC) vs Market Standing Certificate (MSC)
CDSCO's guidance document covers both certificates together, and they're often applied for side by side, but they answer different questions:
| Parameter |
Non-Conviction Certificate (NCC) |
Market Standing Certificate (MSC) |
| What it confirms |
No conviction or regulatory action for adverse events, complaints, or NSQ reports |
The company has an established, ongoing sales track record for the licensed device in India |
| Core evidence required |
Legal undertaking (notarized) declaring no adverse action |
Sales data (Bills of Entry for imports, or CA-certified sales details) for the last 3 years |
| Typical use case |
Government tenders, institutional bids, compliance verification |
Bank loans, tenders, foreign market registration, proving commercial track record |
| Validity |
Commonly cited as 1 year, or till license validity, whichever is earlier |
1 year from issuance, or till license validity, whichever is earlier |
Many applicants request both certificates in the same application, since tenders and institutional bids often ask for both a clean compliance record and proof of market presence.
Who Can Apply for a CDSCO Non-Conviction Certificate?
Medical device manufacturers holding a valid manufacturing license (MD-5 for Class A/B, or MD-9 for Class C/D) under the Medical Devices Rules, 2017.
Medical device importers holding a valid import license (MD-15) for any device risk class.
Companies applying to government tenders, hospital empanelment processes, or institutional procurement bids that specifically request an NCC.
Manufacturers seeking to support a foreign regulatory submission that asks for confirmation of a clean compliance record in the country of manufacture.
You cannot apply for an NCC without an existing, valid manufacturing or import license — the certificate is issued against your license and product list, not as a standalone document.
Which Authority Issues the NCC?
| Device Class & License Type |
Issuing Authority |
| Class C & Class D devices under a manufacturing license |
Central Licensing Authority (CLA / CDSCO) |
| Devices of any class (A, B, C, or D) under an import license |
Central Licensing Authority (CLA / CDSCO) |
| Class A & Class B devices under a manufacturing license |
State Licensing Authority (SLA) |
In short:
import license holders and Class C/D manufacturers apply centrally through CDSCO, while Class A/B manufacturers apply through their State Licensing Authority.
Documents Required for an NCC Application
Based on CDSCO's own published Annexure B checklist, an NCC application requires just four items — making it one of the lighter CDSCO filings compared to a fresh license or endorsement application:
Cover letter, clearly stating the intent of the application and listing the documents submitted.
Application for NCC — the system-generated application form reflecting your license number and the product list for which the NCC is requested.
A copy of your valid manufacturing or import license, along with the retention application file number for all applied products, if applicable.
A legal undertaking, on a Rs. 100 registered notarized stamp paper, declaring that no action has been initiated against the company and that it has not been convicted for adverse events, market complaints, or NSQ reports relating to the applied products.
Step-by-Step Process: Applying for an NCC
Confirm your manufacturing or import license is valid and identify the exact products (generic name, brand name, model number) you want the NCC to cover.
Prepare the cover letter, clearly stating that you're applying for a Non-Conviction Certificate and listing the documents being submitted.
Get the legal undertaking drafted and executed on a Rs. 100 registered stamp paper, notarized, declaring no conviction or regulatory action against the applied products.
Log into CDSCO's Medical Devices online portal (www.cdscomdonline.gov.in) and complete the system-generated NCC application, which will reflect your license number and product list.
Upload the cover letter, license copy (with retention file number if applicable), and the notarized legal undertaking.
Submit the application to the concerned licensing authority — the Central Licensing Authority for import licenses and Class C/D manufacturing licenses, or the State Licensing Authority for Class A/B manufacturing licenses.
Respond to any query the licensing authority raises, particularly around discrepancies between the applied product list and your current license.
On satisfactory review, the certificate is generated — since April 2025, this happens through CDSCO's auto-generated digital workflow for eligible applicants.
CDSCO Non-Conviction Certificate Fees
CDSCO's published guidance document for the NCC does not specify a separate government fee for the application, distinct from the fees already paid for your underlying manufacturing or import license.
Verify before you file :
Since fee structures can be updated and may vary by licensing authority, confirm directly with CDSCO or your State Licensing Authority via the SUGAM/Medical Devices portal whether any processing fee applies to your specific NCC application before submitting.
Validity and Renewal of the Non-Conviction Certificate
CDSCO's guidance document explicitly notes that the Market Standing Certificate is valid for 1 year from the date of issuance, or till the validity of the underlying license, whichever is earlier, provided no regulatory action has been initiated on the applied products. Since the NCC is covered under the same combined guidance document and has historically shared this validity structure, the same 1-year cycle is commonly applied to NCCs as well.
There's no traditional "renewal" filing — you simply submit a fresh NCC application when you need a current certificate, typically for a new tender or bid.
If regulatory action is initiated against any of the applied products during the certificate's validity, that can affect your ability to rely on (or renew) the certificate.
Because tenders and institutional buyers often want a recently issued certificate, many manufacturers apply for a fresh NCC specifically when a bid requires one, rather than keeping one permanently on file.
CDSCO NCC Timeline at a Glance
| Stage |
Typical Timeframe |
| Legal undertaking drafting & notarization |
Varies by applicant readiness |
| NCC application submission via CDSCO Medical Devices portal |
After documentation is complete |
| Licensing authority scrutiny and query resolution |
As raised by the Central or State Licensing Authority |
| Certificate generation |
Auto-generated digitally for eligible applicants since April 2025 |
| Certificate validity |
Commonly cited as 1 year, or till license validity, whichever is earlier |
Why Choose Silvereye Certifications For Getting Your NCC Application
A Non-Conviction Certificate is one of the simplest CDSCO filings on paper — just four documents — but tender and bid deadlines rarely allow room for a rejected or delayed application. Getting the product list to match your license exactly, and having the legal undertaking properly notarized on the correct stamp paper, are the two details that most often trip up otherwise straightforward applications.
Silvereye Certifications supports medical device manufacturers and importers with end-to-end NCC (and MSC) applications — from verifying your product list against your current license, to preparing the notarized legal undertaking, filing through CDSCO's Medical Devices portal, and keeping your documentation ready for the next tender or bid that needs it.
Next step :
Need a Non-Conviction Certificate for an upcoming tender or institutional bid? Talk to Silvereye Certifications for a documentation review and end-to-end NCC filing support before your submission deadline.
Frequently Asked Questions: CDSCO Non-Conviction Certificate
It's an official CDSCO document confirming that a licensed medical device manufacturer or importer has not been convicted, or had regulatory action initiated against them, for adverse events, market complaints, or Not of Standard Quality (NSQ) reports on their licensed products.
Medical device manufacturers and importers who need to demonstrate a clean compliance record — most commonly for government tenders, institutional procurement bids, or certain foreign regulatory submissions.
Yes. You must already hold a valid manufacturing license (for Class A, B, C, or D devices) or a valid import license before you can apply for an NCC — it's issued against your existing license and product list, not as a standalone certificate.
An NCC confirms there's no conviction or regulatory action against your licensed products. An MSC confirms your company has an established sales track record for those products in the Indian market over the last 3 years. They're covered under the same CDSCO guidance document and are often applied for together.
The Central Licensing Authority (CDSCO) issues NCCs for import licenses of any device class, and for manufacturing licenses of Class C and D devices. The State Licensing Authority issues NCCs for Class A and B manufacturing licenses.
Just four: a cover letter, the system-generated NCC application form, a copy of your valid manufacturing or import license, and a legal undertaking on a Rs. 100 registered notarized stamp paper declaring no conviction or regulatory action.
Since CDSCO introduced an auto-generated MSC/NCC workflow in April 2025, eligible applicants can receive the certificate digitally in a streamlined manner once the application and documents are verified. Exact timing can still vary based on document accuracy and any queries raised.
CDSCO's published guidance document doesn't specify a separate NCC application fee distinct from your existing license fees. Confirm directly with CDSCO or your State Licensing Authority whether any processing fee applies to your specific application.
CDSCO's guidance document explicitly states a 1-year validity (or till license validity, whichever is earlier) for the Market Standing Certificate, and this same validity structure is commonly applied to the Non-Conviction Certificate as well, since both are covered under the same guidance document.
No. The NCC is issued specifically against the products listed in your valid, current manufacturing or import license. Products outside that license aren't eligible for the certificate.
