SS GLOBAL SERVICES RELIABLE • RESPONSIVE • REASONABLE CDSCO REGISTRATION & LICENSING SERVICES Your trusted regulatory partner for Medical Devices, Pharmaceuticals, Cosmetics & Import/Manufacturing Licenses in India W www.ssglobalservices.in C +91-9717929681 | +91-9999992605 T Landline: 011-40194697 SS GLOBAL SERVICES RELIABLE • RESPONSIVE • REASONABLE www.ssglobalservices.in +91-9717929681 | 011-40194697 CDSCO Regulatory Services • Page 01 UNDERSTANDING CDSCO What is CDSCO? The regulatory authority behind every medical device, drug and cosmetic sold in India The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals, medical devices, in-vitro diagnostics (IVDs) and cosmetics. Functioning under the Directorate General of Health Services, Ministry of Health & Family Welfare, CDSCO operates under the Drugs & Cosmetics Act, 1940 and the Medical Device Rules, 2017 In simple terms — if you manufacture, import, sell or conduct clinical trials for drugs, medical devices, IVDs or cosmetics in India, CDSCO approval or registration is a legal requirement before you can enter the market. What Does CDSCO Regulate? Rx Drugs & Pharmaceuticals New drug approvals, manufacturing & import licenses, clinical trial permissions. MD Medical Devices & IVDs Class A, B, C & D device registration, import and manufacturing licenses. CT Clinical Trials Permissions for trials of new drugs, devices and vaccines on Indian subjects. CB Cosmetics Import registration for cosmetic products entering the Indian market. Why it matters: Selling a non-compliant product, or one without valid CDSCO approval, can lead to product seizure, financial penalties and legal action. A valid registration also builds trust with hospitals, distributors and end customers. SS GLOBAL SERVICES RELIABLE • RESPONSIVE • REASONABLE www.ssglobalservices.in +91-9717929681 | 011-40194697 CDSCO Regulatory Services • Page 02 REGULATORY CATEGORIES Types of CDSCO Registrations & Licenses Choose the pathway that matches your product and business activity A/B Medical Device Class A & B (Low / Low-Moderate Risk) Registration via the SUGAM portal for low-risk devices such as thermometers, surgical dressings and diagnostic kits, typically issued by State Licensing Authorities. C/D Medical Device Class C & D (Moderate-High / High Risk) Central Licensing Authority approval for higher-risk devices — implants, cardiac stents, orthopaedic devices, ventilators and similar critical equipment. IMP Import License (Form MD-14 / MD-15) Mandatory for overseas manufacturers to import and sell medical devices or drugs in India through an Authorised Indian Agent. MFG Manufacturing License Required for domestic manufacturing units producing drugs, devices or IVDs for sale within India or for export. CT Clinical Trial / Investigation Permission Approval to conduct clinical trials or clinical investigations for new drugs, devices or IVDs on Indian subjects. COS Cosmetic Import Registration Registration certificate required for import of cosmetic products into the Indian market under the Cosmetics Rules. SS GLOBAL SERVICES RELIABLE • RESPONSIVE • REASONABLE www.ssglobalservices.in +91-9717929681 | 011-40194697 CDSCO Regulatory Services • Page 03 THE PROCESS How to Get CDSCO Registration A step-by-step path from application to approval 1 Classify Your Product Determine the correct risk class (A/B/C/D) or license type for your drug, device or cosmetic under CDSCO rules. 2 Prepare Documentation Compile technical files, quality certificates (ISO 13485 / GMP), test reports, labelling and Free Sale Certificates as applicable. 3 Appoint an Authorised Indian Agent Foreign manufacturers must appoint a registered Indian Agent to file and liaise with CDSCO on their behalf. 4 Submit Application on SUGAM Portal File the application with fees through CDSCO's online SUGAM portal, along with all supporting documents. 5 Respond to Queries / Deficiencies Address any clarifications or additional data requested by CDSCO reviewers within the given timelines. 6 Receive Approval / License Once satisfied, CDSCO issues the registration certificate or license, enabling legal manufacture, import or sale. Good to know: Processing timelines vary by device class and license type — typically ranging from a few weeks for Class A/B registration to several months for Class C/D licenses and clinical trial approvals. Accurate documentation upfront is the single biggest factor in avoiding delays. SS GLOBAL SERVICES RELIABLE • RESPONSIVE • REASONABLE www.ssglobalservices.in +91-9717929681 | 011-40194697 CDSCO Regulatory Services • Page 04 OUR SERVICES How SS Global Services Can Help End-to-end regulatory support, handled for you Product Classification We assess your product and confirm the correct CDSCO risk class and license pathway before you spend a rupee on filing. Documentation & Compilation Our team prepares and reviews technical files, test reports, labelling and quality certificates to CDSCO standards. Authorised Indian Agent Services We act as your registered Indian Agent, giving overseas manufacturers a compliant, local point of contact. SUGAM Portal Filing We handle the complete online application, fee payment and submission process on your behalf. Query & Deficiency Management We respond promptly to CDSCO clarifications and deficiency letters to keep your application on track. End-to-End Follow-up We track your application status and liaise with CDSCO until your registration or license is issued. Why Choose SS Global Services Reliable Consistent, compliance-first regulatory support you can depend on. Responsive Quick turnaround on queries, filings and CDSCO follow-ups. Reasonable Transparent, competitive pricing with no hidden costs. Let's Get You Compliant Talk to our regulatory experts about your CDSCO registration or license today. W Visit www.ssglobalservices.in C Call / WhatsApp +91-9717929681 +91-9999992605 T Landline 011-40194697 RELIABLE • RESPONSIVE • REASONABLE © SS Global Services — CDSCO Regulatory Consulting