CDSCO Import License for Medical Devices & Drugs Simplified Guide

1. CDSCO Import License for Medical Devices & Drugs: Simplified Guide What is a CDSCO Import License? A CDSCO import license is mandatory for importing regulated medical products into India. This includes:  Medical devices  In-vitro diagnostic devices  Bulk drugs and finished formulations  Cosmetics New drugs or investigational drugs (requires a CDSCO test license)  Depending on the product classification (Class A, B, C, D), the regulatory pathway may vary. Key CDSCO Regulations for Medical Device Imports 1. Mandatory Registration Before being imported, all Class A, B, C, and D devices—diagnostic or therapeutic—must be registered. The SUGAM site is used for registration. 2. Import License Requirement (Form MD-15) In order to import medical equipment, foreign producers need to apply for an import license using Form MD-15 and designate an Indian Authorized Agent (IAA). 3. Device Master File (DMF) Submission The DMF includes:  Product specs  Manufacturing process  Sterilization methods  Labeling and intended use 4. Free Sale Certificate (FSC) Issued by the appropriate government in the nation of origin. evidence that the gadget is sold there lawfully.

2. 5. Power of Attorney (PoA) The foreign manufacturer must issue a PoA to the Indian agent, legalized or apostilled as per Indian norms. 6. CE Certification or ISO 13485 CE certification or ISO 13485 compliance for higher-risk devices (Class C & D) fortifies the application and expedites clearance. 7. CDSCO Registration Fee Fees vary depending on:  Device classification  Quantity and type  Whether it’s a new or existing registration Payment is done through Bharatkosh or the SUGAM portal. Reasons to Register with the CDSCO Legal Compliance CDSCO registration is mandatory under the Drugs and Cosmetics Act, 1940, for anyone importing, manufacturing, or distributing regulated healthcare products in India. Without it, your business risks:  Legal penalties  Product seizures  Market bans 2. Market Access in India Registering with CDSCO gives your company legal authorization to sell and distribute medical products across India. It opens doors to:  Government tenders  Hospital procurement  Public and private healthcare sales 3. Assurance of Product Safety & Quality CDSCO ensures that only tested, certified, and safe products enter the Indian market. By registering, you demonstrate:  Compliance with national and international quality standards

3.  Commitment to patient and consumer safety 4. Smooth Customs Clearance Importing without proper CDSCO documentation can lead to delays or detainment at Indian ports. A valid CDSCO import license:  Eases customs clearance  Avoids unnecessary inspection hold-ups  Reduces warehousing costs 5. Boost Credibility & Trust Having CDSCO registration improves your brand image with:  Hospitals and clinics  Regulatory bodies  Distributors and patients It shows that your product meets India’s stringent regulatory standards. 6. Eligibility for Test & Clinical Trials For companies conducting R&D or entering new markets, CDSCO provides: Test Licenses (for sample imports)  Clinical Trial Approvals (for new drugs/devices) These are crucial for innovation and early product validation.  7. Mandatory for Online Listing & B2B Platforms E-commerce sites, medical device resellers, and B2B distributors often require CDSCO registration as part of vendor onboarding due to rising regulatory awareness. 8. Protection from Counterfeit Competition Registration provides a unique identification for your product and acts as legal proof of authenticity—especially critical in high-risk sectors like pharma and diagnostics. Types of CDSCO Licenses 1.Form 10– For importing drugs 2.Form MD-15– For importing medical devices 3.Test License (Form 11 or MD-16)– Required for samples, testing, or clinical trials

4. CDSCO Online Registration Process CDSCO has made online registration possible through its SUGAM site, thanks to digitalization. Here’s how to get going: Step-by-Step Process: 1.Create an Account on the SUGAM portal 2.Select Registration Type (importer, manufacturer, agent, etc.) 3.Fill in the Application Form for the relevant license (e.g., MD-15 for medical devices) 4.Upload Documents such as:  Free Sale Certificate (FSC)  Power of Attorney  Device Master File (DMF)  Manufacturing License 5.Pay CDSCO Registration Fee online 6.Track Status via the dashboard and respond to any queries from the licensing authority CDSCO Registration Fee (Indicative) License Type Approx. Fee (INR) CDSCO Medical Device Registration ₹1,000 to ₹50,000+ CDSCO Import License for Drugs ₹1,000 to ₹25,000+ CDSCO Test License ₹1,000 to ₹5,000 CDSCO Registration for Medical Devices Medical devices are categorized into four classes: Class A & B– Less risk, managed by State Licensing Authority (SLA)  Class C & D– Higher risk, regulated directly by CDSCO  You must first obtain a CDSCO registration for medical devices before applying for the CDSCO import license.

5. Final Thoughts Importing into India’s regulated healthcare sector isn’t just about getting products across borders—it’s aboutmeeting safety, quality, and legal standards. Whether you’re applying for a CDSCO import license, a CDSCO test license, or completing your CDSCO medical device registration, following the correct procedure ensures smooth operations and uninterrupted market access. For seamless compliance, think about seeking professional help from regulatory consultants or licensing experts. Consulting with knowledgeable partners may help you save time, avoid fines, and expedite the launch of your product in the Indian market, whether you’re calculating the correct CDSCO registration price or handling CDSCO online registration.