Medical devices have a pivotal role in the healthcare industry. These devices are used to diagnose, monitor, and treat patients. In India, the Central Drugs Standard Control Organization (CDSCO) regulates and controls all medical devices entering its market. A CDSCO medical device license has to be secured to manufacture or import medical devices. Notably, CDSCO has categorised medical devices into various classes and different licenses are required for classes. Owing to varying application pathways and licenses for different CDSCO classes, navigating the CDSCO medical device license application guidelines can be tricky. Additionally, first time CDSCO license applicants can find the CDSCO regulatory guidelines confusing and difficult to comprehend. Hence, we have prepared a detailed CDSCO medical device license application guide for first time applicants.
What is the CDSCO?
Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, regulates medical devices in India. It monitors and controls the registration and sale of medical devices in India. The CDSCO works under the guidance of Medical Devices Rules, 2017. Medical Devices Rules, 2017, controls the regulatory framework for medical devices. Medical Devices Rules, 2017, were introduced to align the existing regulatory framework with international standards.
The Drug Controller General of India is the governing body of CDSCO. The CDSCO has two arms: Central Licensing Authority and State Licensing Authority. These arms are vested with different levels of power.
CDSCO plays a crucial role in ensuring patient safety and improved healthcare delivery. CDSCO regulates the approval, manufacturing, and marketing of medical devices. It is responsible for ensuring the safety, efficacy, and quality of these products in India. Thus, it plays a vital role in protecting the public health in India.
CDSCO medical device classification system
The CDSCO medical device license application pathway is governed by CDSCO medical device classification system. Based on the risk level and intended use, medical devices are divided into four classes. The classification system is sorted from the lowest to the highest risk. CDSCO medical device classification list was prepared mainly for the ease of certification, registration, and licensing of medical devices. The manufacturer can fill in the registration and licensing paper work depending on the medical device class.
- Low-risk medical devices are grouped as class A. Examples: gloves, elastic bandages, hot water bags, sphygmomanometer, and walking aids
- Low to moderate-risk medical devices are grouped as class B. Examples: syringes, surgical instruments, blood glucose monitoring devices, nebulizers, and other diagnostic equipment
- Moderate to high-risk medical devices are grouped as class C. Examples: cardiac stents, implantable devices, X-Ray machines, infusion pumps, MRI machines, and ventilators
- High-risk medical devices are grouped as class D. Examples: drug-eluting stents, implanted pacemakers, artificial joints, and heart valves
CDSCO medical device license application pathway: CDSCO medical device license types
Different medical device classes require different licenses. We have provided an overview of the license types. For details regarding the license type for your medical device contact us.
- CDSCO medical device manufacturing license for Class A and B medical devices: CDSCO medical device manufacturing license for Class A and B medical devices is granted on CDSCO MD 5 license. An application has been filed on form MD 3.
- CDSCO medical device manufacturing license for Class C and D medical devices: CDSCO medical device manufacturing license for Class C and D medical devices is granted on CDSCO MD 9 license. An application has been filed on form MD 7.
- CDSCO medical device import license: CDSCO medical device import license for all classes is granted on CDSCO MD 15. An application has been filed on form MD 14.
CDSCO medical device license application guide for first time applicants
We have prepared a detailed CDSCO medical device license application guide for first time applicants.
- Understand the regulatory framework: India’s Medical Device Rules (MDR) 2017 provide the foundation for medical device regulation under CDSCO. Devices are classified into Class A, B, C, and D based on risk, with Class A being low-risk and Class D being high-risk. First-time applicants must carefully determine the classification of their device, as this dictates the application pathway. Misclassification can delay approvals and lead to compliance issues during audits.
- Identify the correct license pathway: Manufacturers must apply for a manufacturing license using Form MD-3/MD-7 depending on the device class. Importers should apply for an import license using Form MD-14. Each pathway has distinct requirements. Hence, CDSCO medical device license application has to be filed accordingly. Choosing the wrong pathway can result in rejection or regulatory penalties.
- Prepare the core supporting documentation: Applicants must compile a Device Master File (DMF) detailing technical specifications, intended use, and performance data. A Plant Master File (PMF) is also required. The PMF should cover site layout, equipment, utilities, and QMS compliance. ISO 13485 certification or equivalent evidence of a Quality Management System is mandatory. Clinical evidence, labeling drafts, and Instructions for Use must align with MDR 2017 standards.
- Establish post-market systems: CDSCO requires applicants to set up a post-market surveillance (PMS) plan to monitor device performance. A qualified person must be nominated to oversee adverse event reporting. Standard Operating Procedures (SOPs) should be prepared for vigilance activities and reporting timelines. These systems ensure patient safety and demonstrate regulatory responsibility.
- Register and submit via SUGAM portal: The CDSCO medical device license application has to be submitted via the SUGAM portal. Applicants must create an account on the CDSCO SUGAM portal, the official online licensing system. All forms, DMF, PMF, and supporting documents are uploaded digitally. The applicable government fees must be paid online, with receipts retained for audit purposes. The portal streamlines submissions but requires careful attention to detail to avoid technical rejections.
- Respond to queries and inspections: CDSCO may raise queries or request clarifications during the review process. Applicants should respond promptly with accurate and complete information to avoid delays. Manufacturing facilities may undergo site inspections to verify compliance with MDR 2017. Preparedness and transparency during inspections build credibility with regulators.
- License grant and maintenance: Once approved, CDSCO issues the license in the prescribed form, allowing legal manufacture or import. License holders must maintain compliance with MDR 2017 and pay license retention fee to maintain license validity. Continuous vigilance and documentation updates are essential for regulatory compliance. Failure to maintain compliance can lead to suspension or cancellation of the license.
5 pro tips for first time applicants
We have listed some pro tips for CDSCO medical device license application.
- Start with a gap assessment: Before preparing your application, conduct a thorough gap assessment against MDR 2017 requirements. This helps identify missing documentation, compliance gaps, or QMS weaknesses early.
- Classify your device correctly: Accurate risk classification (Class A–D) is the foundation of your application. Misclassification can lead to regulatory delays, queries, or even rejection.
- Build a robust QMS early: First-time applicants should establish SOPs, documentation practices, and audit readiness well before submission. A strong QMS demonstrates operational discipline and patient safety commitment.
- Leverage the SUGAM portal efficiently: The CDSCO SUGAM portal is the official platform for submissions, queries, and license issuance. Ensure all documents are uploaded in the correct format and naming convention. Additionally, familiarity with the portal reduces technical errors and accelerates processing.
- Prepare for queries and inspections: CDSCO frequently raises queries to clarify technical or compliance aspects. Respond promptly, with clear and complete documentation, to avoid delays.
New to the CDSCO regulated market? Not sure of the CDSCO medical device license application requirements? Fret not! Our team will be more than happy to help you. Email at [email protected] or call/Whatsapp on 9996859227 and we will handle everything from document preparation, application filling to CDSCO query response. We will provide support till you successfully secure the license.
