CDSCO Non-Conviction Certificate

A Non-Conviction Certificate (NCC) is a legal document given by the Central Drugs Standard Control Organization (CDSCO) in India. This certificate shows that the medical device company has never been punished for selling or making any unsafe or harmful medical device. It also means there is no court case, no fine, and no legal trouble against the company for breaking medical safety rules. This certificate proves that the company makes, sells, or imports medical devices safely and carefully in India. It shows that the company has never caused deaths, serious injuries, device problems, or low-quality products. It also confirms that the company follows all the rules, making its medical devices safe, reliable, and trustworthy for everyone.

The Non-Conviction Certificate holds high value for companies working in the healthcare sector. It acts as a Certificate of Clean Legal Record and proves complete regulatory compliance. Many government and private procurement agencies request this certificate before allowing the supply of medical devices. It helps maintain public safety and prevents unapproved or dangerous medical devices from entering the healthcare system.

Indian medical device companies use this certificate as a Non-Conviction Declaration or Affidavit of Non-Conviction for business submissions and audits. It also plays a key role in establishing transparency, quality commitment, and responsibility in the global medical supply chain. The objective of this requirement is to keep unsafe product manufacturers away from the Indian healthcare market. Hence, NCC supports public trust and encourages ethical operations in the medical device industry.

The CDSCO non-conviction certificate is important because:

• Protects Patient Safety: Makes sure that only safe and approved medical devices reach hospitals, clinics, and healthcare centers.
• Shows Legal Compliance: Proves that the company follows all medical device laws and has no criminal or legal issues.
• Builds Industry Trust: Helps authorities, hospitals, and buyers feel confident about the company's products.
• Supports Government Tenders: Works as an important legal document needed to participate in public tenders and supply opportunities.
• Strengthens Market Reputation: Provides a clean and transparent compliance record that supports brand recognition and business credibility.
• Enhances Global Acceptance: Helps companies work with international agencies that require proof of a clean legal status before business expansion.

What Are the Uses of a Non-Conviction Certificate (NCC)?

A Non-Conviction Certificate is used for:

• Participation in Government and Public Hospital Tenders: The Non-Conviction Certificate allows medical device companies to take part in public procurement programs where safety and compliance are mandatory requirements.
• Support During License Renewals and Certifications: The certificate helps show that the company maintains a clean legal record, which makes the renewal and continuation of regulatory permissions easier.
• Proof of Compliance in Audits and Inspections: It acts as legal evidence that the company follows all rules of the Drugs and Cosmetics Act without any conviction.
• Growing Trust in Procurement Processes: Authorities check the certificate before selecting suppliers to ensure a reliable and safe product supply.
• Improved Reputation and Market Entry: It helps companies enter new business sectors with proof of good regulatory behaviour.

Who Issues the Certificate of Non-Conviction?

The authority responsible for issuing the Non-Conviction Certificate depends on the company's license jurisdiction. If the State Licensing Authority (SLA) has granted the manufacturing or import license, then the same state authority issues the Certificate of Non-Conviction. When the license comes under the Central Licensing Authority (CLA), the Central Drugs Standard Control Organization (CDSCO) grants the NCC. The issuing authority checks the legal status of the company and confirms the absence of any conviction before approving the request. This verification process ensures accuracy and prevents entry of non-compliant manufacturers or importers into the healthcare supply chain. The role of the authority ensures a transparent, safe, and law-abiding medical device industry.

Medical device companies that follow the required rules can apply for a Non-Conviction Certificate (NCC).

• Licensed Medical Device Manufacturers: Any company with a valid manufacturing license from the Central Licensing Authority (CLA) or State Licensing Authority (SLA) under the Drugs and Cosmetics Act can request an NCC. This shows the company operates legally and safely.
• Licensed Medical Device Importers: Importers with a valid CDSCO import license can submit an NCC request to confirm their clean legal record within India.
• Companies with No Criminal Convictions: Only organizations with zero history of conviction, penalty, or legal action for violations related to device safety, poor quality, or patient harm are eligible.

The documents required for applying for a non-conviction certificate are:

• Covering letter to SLA or CLA
• List of licensed medical devices
• Authorization letter of the signatory
• Valid license copies or a renewal certificate
• Affidavit of Non-Conviction on notarized stamp paper

To get an NCC for medical devices, the applicant must follow the regulatory process decided by CDSCO. It requires submitting documents and proof of compliance to the authority. Here are the steps to obtain the Non-Conviction Certificate:

• Application Preparation: The company, along with all necessary compliance information, prepares a detailed Non-Conviction Declaration.
• Formal Submission: A request is submitted to the relevant licensing authority responsible for issuing approvals in medical device matters.
• Document Verification: The authority verifies records to ensure no conviction or legal action exists against the company or its products.
• Regulatory Review: A detailed evaluation is carried out to confirm public safety, adherence to quality standards, and compliance with laws.
• Certificate Issuance: When all details meet the legal requirements, the authority officially grants the Non-Conviction Certificate.

The Non-Conviction Certificate (NCC) is usually valid for one year from the date it is issued, or until the company’s manufacturing or import license expires, whichever comes first. Renewing the certificate on time helps the company continue its business smoothly and shows that it follows all rules. Companies that take part in government tenders often keep their NCC up to date. Having a valid NCC all the time proves that the company is responsible, safe, and reliable in making or selling medical devices.

What happens if CDSCO rejects the NCC Application?

If rejected, the company may face:

• Delay in medical device supply approvals
• Disqualification from procurement tenders
• Increased regulatory observation and reviews
• Audit requests for corrective compliance
• Negative impression on business trust and reputation
• Need to correct issues and reapply for NCC

Corpseed is one of the top consulting firms, offering comprehensive assistance in the medical device and pharmaceutical compliance, guiding businesses through the necessary processes. Our team helps companies get the CDSCO Non-Conviction Certificate (NCC) smoothly and ensures all legal and regulatory requirements are met. Corpseed provides step-by-step support, making the process simple, fast, and accurate. Our Services Include:

• Document Preparation: We help prepare all required documents correctly to avoid delays.
• Application Guidance: We guide companies on how to submit the NCC application properly to the licensing authority.
• Regulatory Review: Our experts check all compliance details to ensure the application meets CDSCO standards.
• End-to-End Assistance: From document collection to final certificate issuance, we manage the entire process.
• Follow-Up Support: We handle queries and communicate with authorities to ensure smooth approval.