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CDSCO Registration for Medical Devices

The CDSCO Manufacturing License is a mandatory approval for companies producing medical devices in India. Under the Medical Devices Rules, 2017, no manufacturer can legally produce, assemble, or package medical devices without this license. It ensures that every device entering the Indian market meets essential safety and quality standards.<br><br>Medical devices are classified into Class A, B, C, and D based on risk level. Depending on classification, manufacturers must apply through the CDSCO online portal using the appropriate forms, submit technical documents such as the Device Master File and P

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CDSCO Registration for Medical Devices

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  1. CDSCO Registration Guide for Medical Devices in India Subtitle: Overview, Process & Compliance Checklist You can put your company logo here + a suitable background medical-device / regulatory theme 1. What is CDSCO? ● CDSCO — Central Drugs Standard Control Organization — is the national regulatory authority in India under the Ministry of Health & Family Welfare. It is responsible for regulating drugs, medical devices, diagnostics, clinical trials, import/export licensing, and ensuring safety, quality, and performance standards for medical products in India. (CDSCO) ● All medical devices (manufactured in India or imported) must comply with CDSCO regulations before being marketed/sold in India. (Operon Strategist)

  2. 2. Why CDSCO Registration Matters

  3. ● Ensures safety, quality, and efficacy of medical devices — protecting public health and patient safety. (Operon Strategist) ● Legal compliance — only CDSCO-registered devices can be legally sold, imported, or manufactured in India. (Operon Strategist) ● Provides market access to the Indian medical market — for domestic manufacturers, importers, and foreign companies wishing to enter India. (Operon Strategist) ● Enhances credibility and trust — helps build brand reputation, and assures hospitals, distributors, and regulatory authorities that the device meets required standards. (Operon Strategist) 3. Classification of Medical Devices (as per CDSCO) Clas s Risk Level Examples of Devices A Low risk Bandages, basic instruments (e.g. examination gloves) (Operon Strategist) B Low-to-moderate risk BP monitors, thermometers, syringes/needles (non-invasive devices) (Operon Strategist) C Moderate-to-high risk Catheters, implants, certain diagnostic devices (Operon Strategist) D High risk Heart valves, pacemakers, life-support devices, etc. (Operon Strategist) This classification determines what kind of license (import/manufacturing) or registration process is required. (Operon Strategist) Include an image like a “device-risk classification chart” to visually represent this.

  4. 4. Who Needs CDSCO Registration / License CDSCO registration (or license) is required if you are: ● A manufacturer in India producing medical devices or IVDs. (Operon Strategist) ● An importer or distributor/import-export company bringing medical devices into India. (Operon Strategist) ● A foreign manufacturer wanting to sell devices in India — via an authorized Indian agent. (Operon Strategist) ● A legal representative or subsidiary of a foreign company intending to market in India. (Operon Strategist) This ensures regulation is consistent regardless whether device is made domestically or imported. 5. CDSCO Registration / Licensing Process — Step by Step Here’s a typical workflow for registering a medical device with CDSCO: 1. Device Classification — Determine correct risk class (A, B, C, or D) as per device type and intended use. (Operon Strategist) 2. Prepare Documentation — Compile all required technical, administrative, regulatory documents: device description, intended use, manufacturing details, quality management certificates (e.g. ISO 13485 if applicable), Free Sale Certificate (if import), clinical data (if required), labeling/packaging details, etc. (NB Advisors) 3. Appoint Indian Authorized Agent (if foreign company) — For foreign manufacturers, a local agent/representative is required to act on behalf of the company for submissions. (Operon Strategist) 4. Online Application Submission — Submit application via CDSCO “MD Online” portal using appropriate form (e.g. MD-14, MD-15 for import; MD-3/MD-5/MD-7 for manufacturing; or other forms depending on case). (Operon Strategist)

  5. 5. Technical Review & Queries Handling — CDSCO reviews the submitted dossiers; may raise queries or request clarifications — these must be addressed. (Operon Strategist) 6. Certificate/Licence Issuance — Once approved, you receive the official CDSCO registration certificate or import/manufacturing license. (Operon Strategist) 7. Post-Approval Compliance & Maintenance — Maintain regulatory compliance including labelling, quality systems, renewals or updates as needed. (Operon Strategist) You may include a flowchart image here for clarity.

  6. 6. Licenses & Application Forms (Depending on Situation) Situation Required License / Form Import of medical devices (any class) Import License — Forms MD-14, MD-15 (or MD-26/MD-27 for new devices) (Operon Strategist) Manufacturing in India — Class A & B devices Manufacturing License — Forms MD-3 (or MD-4 for loan license), permission MD-5/MD-6 (Operon Strategist) Manufacturing in India — Class C & D or non-notified devices Manufacturing License — Forms MD-7, permission MD-9/MD-10 (or related) (Operon Strategist) Clinical Investigation or new device registration (import/manufacture) Forms MD-22 / MD-23, or MD-16 / MD-17 depending on type (Operon Strategist) You may include a table or infographic summarizing the forms and when each is used. 7. Key Requirements & Compliance Criteria When applying for CDSCO registration/licence, the following are typically required: ● Correct device classification (risk class) as per regulation. (Operon Strategist) ● Complete technical documentation: device description, specifications, intended use, design/manufacturing process, sterilization (if applicable), labeling, shelf life, packaging, etc. (NB Advisors) ● Quality management system compliance (e.g. ISO 13485 or relevant standard, if required) or other regulatory certificates as applicable. (NB Advisors) ● For imported devices: free sale certificate, regulatory clearances from origin country (if applicable), authorized Indian agent representation. (Operon Strategist) ● Payment of applicable fees, correct submission via CDSCO portal, and follow-up on any queries post submission. (Operon Strategist)

  7. 8. Benefits of Getting CDSCO Registration ● Legal authorization to manufacture/import and sell medical devices in India — mandatory for market access. (Operon Strategist) ● Builds credibility and trust — demonstrates compliance with Indian regulatory standards, which helps in gaining trust from hospitals, distributors, clients, and stakeholders. (Operon Strategist) ● Opens access to public and private procurement tenders — many tenders require CDSCO-registered devices; unregistered devices may be disqualified. (Operon Strategist) ● Ensures device safety, quality and performance — helps avoid legal or safety issues, ensures regulatory compliance, and supports long-term brand reputation. (Operon Strategist) 9. How a Regulatory Consultant / Support Partner Can Help Working with an experienced regulatory consultant (or your internal regulatory team) can help because: ● They guide correct device classification and identify applicable regulations under CDSCO. (Operon Strategist) ● They help prepare and review the full documentation and technical dossiers — reducing risk of errors or rejections. (Operon Strategist) ● They can handle online submissions through the CDSCO portal, follow-ups, query responses, and communication with regulatory authorities. (Operon Strategist) ● They support post-approval compliance, updates, renewals, labeling, audits, quality system setup — ensuring long-term regulatory adherence. (Operon Strategist) If you plan to make a PDF for internal or external distribution, using a consultant partner can make the process smoother and more reliable.

  8. 10. Suggested Structure for Your PDF Document Here’s a recommended structure (table of contents) for your PDF — you can adapt/expand as needed: 1. Title Page 2. Introduction — What is CDSCO & Why it Matters 3. Overview of CDSCO’s Role in Medical Device Regulation 4. Device Classification (Class A–D) & What It Means 5. Who Needs CDSCO Registration / License 6. Step-by-Step Registration / Licensing Process 7. Required Documents, Forms & Submission Process 8. Compliance Criteria & Quality Standards 9. Benefits of CDSCO Registration 10. Role of Regulatory Consultants / Support Partners 11. Checklist for Applicants (preparation & submission) 12. FAQs (common doubts) 13. Conclusion & Next Steps / Contact Info For visual appeal, you can incorporate: charts/infographics for classification, flow diagrams for process steps, sample images of devices (low-risk vs high-risk), screenshots of CDSCO portal or forms (if permitted), and perhaps logos or compliance icons. Written By Dhole Abhishek

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