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The Dual Use NOC, issued by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017, is required for products intended for both IVD and non-IVD purposes. This approval helps establish regulatory clarity on the product’s intended use and applicable compliance requirements. Securing a dual use NOC further helps establish regulatory clarity on the product’s intended use, classification, and applicability of medical device regulations. At Corpbiz, we help you get your Dual Use NOC without any stress.
CDSCO helps evaluate the product’s intended use justification, technical details, labelling, and regulatory declarations to determine whether it falls within the scope of medical device regulations. Partner with Corpbiz to ensure accurate classification, complete documentation, and smooth coordination with CDSCO for obtaining a Dual Use NOC without regulatory uncertainty. Trusted by 1000+ manufacturers, importers, and traders PAN India for expertise, smooth process, and time-saving approach.
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The key benefits of securing a CDSCO dual use NOC are outlined below:
Obtaining a CDSCO dual use NOC clearly defines whether the product is permitted for IVD, research, or dual use, thereby reducing the risk of misclassification.
Securing a CDSCO dual use NOC helps facilitate the uninterrupted import, manufacture, and supply of dual use products without customs or regulatory delays.
Securing a CDSCO dual use NOC helps regulate and control the use of products that could otherwise be misused for diagnostic purposes without approval.
Obtaining a CDSCO dual use NOC ensures that products comply with applicable CDSCO regulations, preventing regulatory violations and maintaining uninterrupted regulatory compliance.
Securing a CDSCO dual use NOC enables lawful placement of the product in both diagnostic and non-diagnostic segments, as approved.
Securing a CDSCO dual use NOC demonstrates regulatory compliance and clarity of intended use, thereby strengthening confidence among regulators, business partners, laboratories, and institutional buyers.
The key eligibility criteria to obtain NOC for dual use products are as discussed below:
The applicants eligible to obtain an online dual use NOC in India are as follows:
The list of documents needed to obtain dual use NOC CDSCO is as follows:
The process for obtaining a dual use certificate in India, as specified under Phase I, is as discussed below:
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After the grant of a CDSCO Dual Use NOC, the following post-clearance and compliance actions are required, as applicable:
Post-clearance compliance ensures the import clearance of dual use products through designated ports.
The products must be manufactured, imported, and supplied strictly in compliance with the approved scope of use, labelling, and declarations mentioned in the Dual Use NOC.
Maintaining accurate records of quantities imported, manufactured, supplied, or distributed is a mandatory post-clearance requirement.
The importer is required to enter all transaction details into the online Supply Chain Module on the SUGAM portal for tracking and reconciliation.
After the grant of a dual use NOC, the importers must submit reconciliation data of previously permitted and used quantities of the material.
The actual user must maintain books and records of all transactions related to the imported material and must further allow the appointed inspector to inspect these records.
Some of the examples of dual use products used as in-vitro diagnostic devices and for non-diagnostic purposes are provided below:
| Central Licensing Authority (CDSCO) | State Licensing Authority |
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Our experts conduct a feasibility assessment to determine dual use applicability, intended-use positioning, IV risk classification, and the appropriate CDSCO regulatory pathway.
We at Corpbiz assist in evaluating whether the products qualify as IVDs, non-diagnostic devices, or dual use devices as specified under MDR 2017.
We support the compilation and review of product descriptions, technical summaries, risk analyses, and regulatory declarations required for a dual use NOC submission.
Our Corpbiz experts act as a single point of contact for responding to CDSCO queries, clarifications, and deficiency letters through the SUGAM portal.
Connect Corpbiz to ensure end-to-end handling of SUGAM portal registration, online application filing, document uploads, and application tracking.
We help conduct GAP analysis against applicable provisions of the Medical Devices Rules, 2017, relevant to dual use products.
Get Corpbiz’s expert-led support while dealing with imported or domestically handled dual use products, thereby ensuring regulatory clarity before market placement.
We at Corpbiz help frame intended-use statements, claims, and labelling that align with CDSCO expectations, thereby reducing the risk of misclassification or rejection.
Our experts offer ongoing support for post-approval compliance, scope, amendments, product changes, and regulatory updates related to Dual Use NOC.
Corpbiz holds focused expertise in evaluating products with both diagnostic and non-diagnostic applications, thereby ensuring the correct determination of dual use applicability and regulatory scope.
With the help of our CDSCO professionals, you will be able to reduce your compliance burden by up to 40%.
With 10+ years of regulatory experience in medical devices and regulatory advisory, we help manage complex CDSCO approvals for dual use NOC in India.
Corpbiz, having a nationwide presence, assists clients across multiple states and regulatory jurisdictions, ensuring smooth coordination with CDSCO and State Authorities where applicable.
We hold strong experience across a wide range of IVD reagents, kits, consumables, instruments, and laboratory products.
Connect Corpbiz to ensure all submissions are prepared with a focus on accuracy, consistency, and audit readiness, suitable for regulatory scrutiny.
Connect with Corpbiz to ensure proactive identification of regulatory red flags such as over-claiming, ambiguous intended use, or misaligned documentation.
Connect Corpbiz to get access to multi-level internal review, ensuring error-free data entry and document mapping before submission on the CDSCO SUAGM portal.
Corpbiz supports clients beyond approval, providing continuous regulatory advisory services rather than a one-time filing service.
Apply for dual use NOC today.
Legal Researcher
Written by Neha Dawra. Last updated on Jun 15 2026, 05:57 PM
Neha Dawra has 4+ years of experience in legal research and intellectual property advisory. Her expertise lies in analyzing IP laws, drafting structured legal content, and simplifying complex registration procedures into clear, simple insights.
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