Medical Device Registration in India: CDSCO License, Process & Fees

Medical Device Registration: Eligibility, Online Process, Fees & Documents

Medical devices can only be used in India with the government's permission. As per the Medical Device Rules, 2017, manufacturers, sellers, or retail sellers must have the mandatory CDSCO medical device registration in India. A valid license demonstrates that the devices available in the market are safe and have been thoroughly tested.

It confirms that the particular distributor or seller is registered with CDSCO, as per the government's notification. The medical device license can be obtained by Indian manufacturers, importers, and Indian agents of imported medical devices. In addition, the CDSCO SUGAM portal is an online portal that facilitates the entire registration process.

LegalRaasta simplifies these complex government processes, having assisted over 100,000 businesses with their compliance needs quickly and cost-effectively.

What is Medical Device Registration in India?

The medical device registration process in India is a comprehensive procedure in which businesses or retailers register with CDSCO. The Central Drug Standard Control Organization (CDSCO) issues the regional drug license that grants legal permission to local businesses to trade medicines for a fee.

The registration process ensures that only reliable and authentic persons are permitted to market the devices. Also, before application approval, they need to demonstrate that their medical devices are safe, secure, and efficient to use.

Key Components of the Registration Process

• Online Registration: The key steps in online registration are form submission, documentation, and CDSCO assessment.
• Costs: The registration fee depends on the device class (A, B, C, and D) and the type of business (manufacturer or importer).
• Essential Documents: TTo avoid a defective registration, it's essential to include device information, an ISO registration of 13485 certificate, a Free Sale Certificate (for imports), and quality control documents.

Importance of Medical Device Registration in India

An online medical device license is more than a formality. It is required to ensure the sustainability of medical devices before being placed in the market. The Central Drugs Standard Control Organisation (CDSCO) is the quality and safety control body under the Medical Devices Rules, 2017. CDSCO fulfils important functions including:

• Patient Safety: Confirming that devices have been subjected to testing, clinical trials, and other processes to establish their quality and ensure safety for patients.
• Quality Assurance: Indicating that a device meets certain standards of quality and is produced through good manufacturing practices.
• Market Access: Offering quicker entry into the market for early-stage manufacturers or distributors, relative to those without a licence.
• Supply Chain Tracking: Enabling the regulator to monitor the supply and control of medical devices in India.

Centralising quality, CDSCO registration helps standardise Indian regulations to international standards to ensure that medical devices in India adhere to a high level of quality and safety to protect end users.

Who Regulates Medical Device Registration in India?

Several authorities exist, including regulatory bodies that mediate medical device registration for safety, quality, and other standards.

The Key Regulatory Authority

• CDSCO (Central Drugs Standard Control Organization): It is India's key regulatory authority for the management of medical devices. CDSCO regulates the safety, quality, and other standards.
• DCGI (Drugs Controller General of India): It is the head of CDSCO and is responsible for the quality of the new regulations and other operations.
• Central Licensing Authority (CLA): It is the authority to license manufacturers and importers of Class C & D medical devices.
• State Licensing Authority (SLA): It is responsible for licensing Class A & B medical devices.

The Key Regulatory Authority

The main regulations for medical devices are the Drugs & Cosmetics Act (1940) and the Medical Devices Rules (2017). Regulations must ensure the safety, quality, and performance of the medical devices.

Recent Policy Update

Draft Medical Devices Rules 2017 Amendment (G.S.R 883 (E)) issued in December 2025 stresses the perpetual license rule. It decides that the license shall remain in force until it is suspended, cancelled, or surrendered. Additionally, in April 2025, two completely online systems were launched: Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC).

Who Needs Medical Device Registration in India?

If you are an entity or an individual involved in the import, manufacture, sale, distribution or use of medical devices in India, you may need "Medical Devices Registration". According to the Medical Devices Rules, 2017 (MFR 2017), medical devices are classified based on their risk factors.

Classification of Medical Device (Class A, B, C, D)

Medical devices are divided into four sections, depending on the level of risk. In the Medical Devices Rules, 2017, this classification of risk determines the regulatory route and the entity to apply for a medical device license for your business.

Below are the key device categories regulated under the latest 2026 compliance framework:

Types of Medical Device Registration in India

The Central Licensing Authority (CLA) oversees the registration process for greater-risk medical devices (class C & D) and import approvals, and State Licensing Authorities (SLA) oversee Class A & B devices, including approval for manufacturing or loan licenses.

Eligibility Criteria for Medical Device Registration in India

The criteria for being eligible for a medical device license are based on the level of risk associated with the device (Class A, B, C, or D) and the geographical location of the manufacturing unit. The Central Drugs Standard Control Organisation (CDSCO) has a clear framework in 2026 to ensure the compliance of manufacturers and importers with the Medical Devices Rules, 2017, in order to ensure the safety of national health care.

1. Core Eligibility for Manufacturers and Importers

Applicants must classify their devices to understand the scrutiny level they will be subjected to (by the Central or State Licensing Authorities).

2. Special Eligibility for Foreign Manufacturers

International manufacturers must meet the "Authorized Agent" and "Market Evidence" criteria to market medical devices in India.

3. Operational and Facility Eligibility

Applicants need to demonstrate that operations and medical devices have data on safety matching technical requirements under the 2026 rules for clinical application.

Benefits of Medical Device Registration in India

The registration of a medical device confers several commercial, regulatory, and operational advantages, which will ensure your business thrives in India's regulated healthcare system.

Documents Required for Medical Device License Registration

The list of required documents for CDSCO registration depends on the classification of the medical device (Class A, B, C, or D) and the status of the company (manufacturer or importer). The mapping of every document required to be successful for filing in 2016 is as follows.

1. General Administrative Documents (Required for All Applications)

• Cover Letter & Undertaking: A letter of application stating the summary of the application and undertaking as per the Medical Devices Rules, 2017.
• Power of Attorney: Authorization letter if the application is made by an Authorized Indian Agent (AIA) on behalf of a foreign company.
• ISO 13485:2016 Certificate: Compulsory notarized and valid Quality Management System (QMS) certificate for the site of manufacture.
• Business Proof: Business registration documents such as a valid PAN card registration, Certificate of Incorporation, and GST Registration for businesses.
• Fee Receipt: Receipt for payment of the required registration fees paid via the SUGAM or NSWS portal.

2. Technical Documents: Device Master File (DMF)

The DMF contains all the technical, design, and performance information to demonstrate the safe functioning of the device.

• Device Description: Intended use, materials, and specifications of the device.
• Design & Manufacturing: History of design, manufacturing processes, and controls.
• Risk Management File: Documented implementation of risk analysis, evaluation, and control, following ISO 14971.
• V&V Reports: Verification and Validation reports (including Engineering and Laboratory reports).
• Labeling & Packaging: Label artwork and Instructions for Use (IFU) artwork for the device, including Indian regulations symbols.

3. Technical Documents: Plant Master File (PMF)

The PMF gives information regarding the manufacturing site and quality control procedures followed.

• General Plant Info: Floor plan of factory buildings and site address of the manufacturing site.
• Quality Management System: Description of in-house testing, the testing laboratories, and the quality manual system of the manufacturing site.
• Infrastructure Details: A list of all the major manufacturing equipment and testing instruments for the specific device.
• Sterilization Validation: (If applicable) Validation details of sterilization (such as Ethylene Oxide, Gamma Irradiation).
• Personnel Details: Details of qualified technical personnel for manufacturing and quality control.

4. Special Requirements for Imports (MD-14/MD-15)

• Free Sale Certificate (FSC): Notarized and valid FSC from the National Regulatory Authority of the importing country.
• Market Evidence: CE/FDA or any other deemed equivalent market evidence from other international regulators.
• Clinical Evaluation Report: Literature summary or clinical investigation data for demonstration of safety to the Indian patient population (continued for class C & D).
• Import Export Code (IEC): An IEC certificate is needed for any Indian company importing/exporting medical devices.

5. Additional Technical Data for Higher Risk (Class C & D)

• Biocompatibility Reports: Reports from accredited laboratories proving compatibility of the device materials with human body contact.
• Performance Test Reports: Reports showing the device meets the claimed technical specifications under usage conditions.
• Stability Data: Displays reports of real-time or accelerated stability tests to back up the claims on the medical devices' shelf life.

Step-by-Step: Medical Device Registration Process in India

To obtain a medical device license in the official SUGAM Online Portal (and integrated NSWS as per 2016) in accordance with the latest regulatory changes, follow the steps below:

Step 1: Identify Applicable Device Classification

• Qualify medical devices as per the risk classification before starting the application process. Check the official CDSCO website to determine whether your medical device is a Class A (low risk), Class B (low - moderate risk), Class C (moderate - high risk), or Class D (high risk). Check the category of risk-based classification in the Medical Devices Rules, 2017.

Step 2: Gather Required Technical Documentation

• Compile all documents, emphasizing device data and manufacturing aspects. For Class C and D: Ensure the Device Master File (DMF) and Plant Master File (PMF) cover all technical specifications, risk assessment, clinical evaluations, and biocompatibility information. Include all correct and updated labeling and packaging artworks.

Step 3: Online Application on SUGAM Portal

• Create an account on sugam.pharma.gov.in (or on cdsco.gov.in). Choose the form for the application (e.g., Form MD-3 for a manufacturer, Form MD-14 for an importer). Upload your technical dossiers (s) and quality management certificates of your product (s).

Step 4: Pay Prescribed Registration Fees

• Pay the specified government fees via the portal's payment gateway. The fees depend on the type of medical device, the number of facilities involved in manufacturing, and your role in the industry, for instance, if you are a manufacturer or an importer.

Step 5: CDSCO Scrutiny & Technical Review

• The Central Drugs Standard Control Organization (CDSCO) officials will continue to audit your application. CDSCO reviews the application and documents for regulatory adherence and may seek additional information if required. The review process may take weeks, months, or years, depending on the type of device and the complexity of the clinical data.

Step 6: Facility Inspection & GMP Compliance

• CDSCO or State Licensing Authority may visit to inspect the facility to ensure regulatory requirements are met. The facility conducting manufacturing should follow current Good Manufacturing Practices (GMP) and Quality Management Systems for Class C and D devices before issuance.

Step 7: Grant of Medical Device License

• Once the medical device is reviewed and inspected for compliance, the authority will issue a medical device license certificate (e.g., Form MD-5, MD-9, or MD-15). This e-certification allows you to manufacture, import, distribute, or sell medical devices in India and can be downloaded from your self-access user account.

Medical Device Registration for Foreign Manufacturers

Foreign manufacturers can apply for a medical device license in India from the CDSCO (Central Drugs Standard Control Organization). These companies need to register following the formal process. Here's what you need to know as a foreign manufacturer for the 2026 compliance framework :

What is the Cost of Medical Device Registration in India?

The cost of medical device registration in 2016 depends on the category of the device, the number of manufacturing facilities, and whether the applicant is a manufacturer or importer in India. The new cost of medical device registration in terms of government fees and operational costs is mentioned below.

Fee Structure by Registration Category

Timeline for Medical Device Registration in India

CDSCO has outlined specific time periods for the medical device registration application review and approval process. These do vary based on the device's classification and the completeness of the technical dossier. Failure to adhere to the timelines for responding to the queries raised can result in the suspension of the application and "deemed rejection" of the application, leading to illegal market entry.

Medical Device Registration Processing Timeline

Validity & Renewal of Medical Device License

The manufacturing and import licenses under the Medical Devices Rules 2017 (MDR 2017) are valid for an infinite period. But the license holder is required to pay the retention fee every five years to stay compliant. The license shall continue to be valid, provided the retention fee is paid, and rules are not breached by manufacturers/importers.

Validity Period

• Manufacturing License (MD-5/MD-9): Can last for as long as possible, if the retention fee is paid every 5 years from the date of issuance of the license.
• Import License (MD-15): Perpetual, once retention fees (overseas site and product) are settled every 5 years (before expiry).
• Loan License (MD-6/MD-10): Usually valid until the manufacturing site license (from which the loan manufacturing license has been given) is valid and retention fees are paid.
• Test License (MD-13): The expiry of the License is 3 years from the date of issue or cancellation/ suspension, whichever is earlier.

Medical Device License Retention Process

• Access the official portal SUGAM, ONDLS, or NSWS through your registered credentials well in advance of your existing five-year license/registration cycle.
• Go to the Retention tab of your license/registration dashboard and select the medical device certificate for retention.
• Review and confirm all the pre-filled information; make changes such as company address, designated signatory, or changes to the manufacturing site layout.
• Upload new documents, including new Quality Management System (QMS) documents, revised Power of Attorney (in the case of AIA), and fresh product testing reports.
• Make the retention fee payment (e.g., ₹5,000/₹50,000 for domestic sites) from the portal.
• The retention request will be reviewed by the authority. A surveillance factory audit or technical audit of documents may be carried out in some cases.
• If the review is satisfactory, the authority retains your license and generates confirmation, downloadable from the portal.

Common Mistakes & Solutions After Medical Device License Rejection

The common mistakes and errors in documents or medical device applications are rejected by the Central Drug Standard Control and Organization (CDSCO). Here is an overview of the mistakes and their solutions to get successful in the design of a medical device filing: