- No Conviction Certificate (NCC): Confirms the company's regulatory compliance status regarding convictions or penalties related to medical device safety and quality, as applicable.
- Online application: Submitted through the dedicated CDSCO MSC/NCC portal, separate from the main SUGAM licensing system.
- Common uses: May be required for government tenders, public hospital procurement and bank loan applications, depending on the relevant requirements.
- Reviewing authority: The application is reviewed by the State or Central Licensing Authority, as applicable to the original manufacturing or import licence.
Introduction
A CDSCO Non-Conviction Certificate (NCC) is an official document relating to a medical device manufacturer's or importer's regulatory and legal compliance status, including matters concerning device safety, quality and Not of Standard Quality (NSQ) complaints, as applicable.
The application is submitted online through CDSCO's dedicated portal. Supporting documents may include a cover letter, completed NCC application, copy of the existing manufacturing or import license, and a notarized legal undertaking on ₹100 stamp paper, subject to current requirements.
An NCC may be required for government and public hospital tenders, bank loan applications and business credibility checks. The application is reviewed by the relevant State or Central Licensing Authority, depending on the applicable procedure and the original license.
What Is a CDSCO Non-Conviction Certificate (NCC)?
A CDSCO Non-Conviction Certificate (NCC) is a document requested by medical device manufacturers and importers to establish their regulatory compliance status for the relevant licensed products. It relates to matters such as device safety, quality and Not of Standard Quality (NSQ) complaints, subject to the applicable CDSCO requirements.
The NCC is relevant to companies holding a valid medical device manufacturing license, such as Form MD-5 or Form MD-9, or an import license in Form MD-15, as applicable. CDSCO has introduced online processes for NCC and the related Market Standing Certificate (MSC). Applicants should check the current portal instructions to confirm the applicable procedure.
Why Is a Non-Conviction Certificate Important?
- Government tenders: May be required for participation in government procurement and public hospital tenders.
- Banking and finance: Banks or financial institutions may request it during loan or credit assessments.
- Business credibility: Can help demonstrate regulatory compliance to buyers, distributors and business partners.
- International business: May support submissions to overseas partners or regulatory authorities when evidence of regulatory standing is requested.
What Is the Difference Between an NCC (Non-Conviction Certificate) and a Market Standing Certificate (MSC)?
The Non-Conviction Certificate (NCC) and Market Standing Certificate (MSC) serve different purposes. Check the applicable CDSCO requirements to confirm which certificate your application or tender requires.
| Certificate | What It Relates To | Typical Use |
|---|---|---|
| Non-Conviction Certificate (NCC) | Regulatory and legal compliance status concerning the relevant licensed medical devices | Government tenders, compliance verification and credibility checks |
| Market Standing Certificate (MSC) | The product's market-standing or marketing history, as defined by the applicable requirements | Tenders, bank assessments and foreign regulatory submissions |
Who Needs to Apply for a CDSCO Non-Conviction Certificate?
An NCC may be relevant to the following applicants, depending on the requirements of the requesting authority or organisation:
- Medical device manufacturers holding a valid manufacturing licence, such as Form MD-5 or Form MD-9, where applicable.
- Medical device importers holding a valid Form MD-15 import licence.
- Companies participating in government or public hospital tenders that specifically request an NCC.
- Businesses applying for loans or credit facilities where the bank or financial institution requires regulatory-status documentation.
What Are the Eligibility Requirements for a CDSCO Non-Conviction Certificate?
Before applying, review the relevant licence, product details and current CDSCO requirements.
- Valid licence: The applicant should hold the applicable, valid manufacturing or import licence for the product covered by the application.
- Regulatory compliance: The application and undertaking must accurately disclose relevant convictions, penalties or regulatory actions, as required by the applicable checklist.
- Product-specific information: Check whether any NSQ findings, adverse-event reports or market complaints concerning the applied products must be disclosed or affect eligibility.
Do not assume that every complaint or regulatory action automatically makes an applicant ineligible. The effect depends on the applicable rules, the facts and CDSCO's assessment.
Which Documents Are Required for a CDSCO Non-Conviction Certificate Application?
The application checklist should be confirmed through the latest official CDSCO instructions. The documents listed in the provided draft include:
- Cover letter: Addressed to the relevant Licensing Authority.
- Completed NCC application: Filled in with the required company, licence and product details.
- Valid manufacturing or import licence: Include the applicable licence copy and the retention application file number for the relevant products, where required.
- Legal undertaking: A notarised undertaking on ₹100 stamp paper, where specified, from the manufacturer or importer. It should accurately address the required declarations concerning regulatory actions, adverse events, market complaints and NSQ reports for the products covered by the application.
How to Apply for a CDSCO Non-Conviction Certificate (NCC): Step-by-Step Process
- Verify your licence: Ensure your manufacturing or import licence is valid and covers the specific medical device(s) for which you need the NCC.
- Prepare the documents: Gather the cover letter, completed NCC application, licence copy and retention application file number, where applicable.
- Prepare the legal undertaking: Arrange the required undertaking and notarization in the format specified by the current CDSCO checklist.
- Submit the application online: Use the designated CDSCO portal, and follow the current application instructions.
- Confirm the reviewing authority: The application is reviewed by the relevant State or Central Licensing Authority, according to the applicable procedure and licence details.
- Respond to queries: Provide any additional documents or clarifications requested by the reviewing authority.
- Receive the certificate: Once the application is reviewed and approved, obtain the Non-Conviction Certificate for the relevant product(s).
What Are the Fees for a CDSCO Non-Conviction Certificate?
The applicable fee should be confirmed using the latest CDSCO instructions and online application portal. Do not assume a single fixed amount applies to every application. Check the fee displayed or prescribed for your application before making payment.
How Long Does CDSCO Non-Conviction Certificate Approval Take?
A single, guaranteed turnaround time should not be assumed for CDSCO Non-Conviction Certificate applications. Processing may depend on the reviewing authority, the completeness of your documents and whether additional clarification is required.
If you need an NCC for a government tender, bank application or compliance deadline, apply well in advance and monitor the application status through the relevant portal. Confirm any published processing timeline with CDSCO or the responsible licensing authority.
What Is the Validity of a Non-Conviction Certificate?
The validity and acceptance of an NCC depend on the applicable CDSCO requirements and the purpose for which it is requested. Do not assume that the certificate has a universal validity period or that it remains acceptable after the underlying licence details change.
Before using an NCC for a tender or other submission, check whether the receiving organization requires a recently issued certificate. If your manufacturing or import license changes, verify whether an updated NCC is necessary.
What Common Issues Can Delay or Affect an NCC Application?
- Expired or incorrectly referenced licence: Check that the underlying manufacturing or import licence is valid and the details match the application.
- Incorrect undertaking: Ensure the undertaking follows the current prescribed format and notarisation requirements, where applicable.
- Missing retention details: Include the retention application file number if required for your licence.
- Unresolved regulatory issues: Review relevant Not of Standard Quality (NSQ) findings, market complaints and regulatory actions, and disclose information as required.
- Incorrect reviewing authority: Confirm the appropriate State or Central Licensing Authority before submitting the application.
- Incomplete documentation: Check the latest official checklist to ensure all required documents are included.
Why Choose Silvereye Certifications for CDSCO NCC Assistance?
Silvereye Certifications assists medical device manufacturers and importers with preparing and reviewing Non-Conviction Certificate (NCC) applications. Support may include checking the underlying licence and retention details, preparing the required undertaking, reviewing documents and coordinating the application through the relevant CDSCO online process.
The team can also help you determine whether you need an NCC, a Market Standing Certificate (MSC), or both, based on the requirements of your tender, bank or business partner.
For assistance with your NCC application, contact Silvereye Certifications to discuss your licence details, document requirements and the applicable filing process.
Frequently Asked Questions
What is a CDSCO Non-Conviction Certificate?
It's an official CDSCO document confirming that a medical device manufacturer or importer has not been convicted, penalized, or subject to legal action related to device safety, quality, or Not of Standard Quality complaints.
Who needs a Non-Conviction Certificate?
Manufacturers and importers holding a valid CDSCO manufacturing or import license typically need an NCC for government tenders, bank loans, or compliance verification purposes.
What documents are required for an NCC application?
Key documents include a cover letter, the NCC application form, a copy of your valid manufacturing or import license, and a notarized legal undertaking on ₹100 stamp paper confirming no conviction or NSQ findings.
How is an NCC different from a Market Standing Certificate?
An NCC confirms your company has no conviction or legal action tied to device safety or quality. A Market Standing Certificate confirms you have an active, established track record of manufacturing or selling the device in India.
Where do I apply for a CDSCO Non-Conviction Certificate?
Applications are submitted online through CDSCO's dedicated portal for these certificates, routed to whichever authority granted your original license.
How long does it take to get an NCC?
CDSCO hasn't published a fixed turnaround time, though processing has generally become faster since the April 2025 move to an auto-generated online workflow. Apply well ahead of any tender or loan deadline.
What is the fee for a CDSCO Non-Conviction Certificate?
Fees are prescribed under the Medical Devices Rules, 2017, and can vary by licensing authority and product — always confirm the current fee on the CDSCO portal before applying.
Does the Non-Conviction Certificate expire?
It doesn't carry a long fixed validity period like a manufacturing license. It's tied to your compliance status and current license details, and is generally obtained fresh for each specific need.
Can I get an NCC if my product has had a market complaint?
If there's an active or unresolved Not of Standard Quality finding, adverse event, or legal action tied to the applied product, it can prevent issuance of the NCC for that product until the matter is resolved.
Is the Non-Conviction Certificate mandatory for all manufacturers?
It's not a blanket requirement for every license holder — it becomes necessary when a specific need arises, such as a government tender, bank loan application, or a buyer's compliance check.
Who reviews and issues the NCC?
The application is reviewed and the certificate issued by whichever authority — the State Licensing Authority or the Central Licensing Authority — originally granted your manufacturing or import license.
