The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, medical devices, and cosmetics, operating under the Ministry of Health and Family Welfare. Medical devices in India are governed by the Medical Devices Rules, 2017 (MDR 2017), notified under the Drugs and Cosmetics Act, 1940. As of 2025, all notified medical devices require prior registration and licensing for import, manufacturing, sale, and distribution to ensure safety, efficacy, and quality.
Importing medical devices without a valid Import License (IL) in Form MD-15 is prohibited, and violations can lead to penalties under the Act. The process is managed through the SUGAM online portal (cdscoonline.gov.in), with the Central Licensing Authority (CLA) overseeing approvals. Foreign manufacturers must appoint an Authorized Indian Agent (AIA) holding a valid wholesale drug license (Forms 20B/21B) or equivalent under MDR 2017.
This guide details the complete 2025 process, incorporating updates like the September 2025 introduction of “Subsequent Importer” provisions and auto-generated certificates. The process is sequential: first obtain a Registration Certificate (RC) in Form MD-42, then the IL. Timelines are risk-based, with higher-risk devices facing stricter scrutiny.
Step 1: Classify Your Medical Device and Verify Notification Status
Medical devices are classified into four risk-based categories under the First Schedule of MDR 2017. Accurate classification determines documentation, fees, and review timelines. Use CDSCO’s published lists, including 2025 updates like the merged risk-classification (January 2025) and draft lists for cardiovascular/neurological devices (April 2025).
| Risk Class | Description | Examples | Key Requirements |
|---|---|---|---|
| Class A | Low risk (non-sterile, non-measuring exempt until Oct 2022) | Bandages, tongue depressors | Basic QMS; no audit for low-risk. |
| Class B | Low-moderate risk | Hypodermic needles, oxygen masks | Notified Body audit; Free Sale Certificate (FSC) from reference countries. |
| Class C | Moderate-high risk | Blood bags, ventilators | Site inspection; clinical data if no predicate device. |
| Class D | High risk | Heart valves, implants | Full dossier; mandatory clinical investigation in India if novel. |
- Verify Notification: Check the CDSCO list of notified devices (updated periodically). Non-notified devices can be voluntarily registered but aren’t mandatory until notified.
- Timeline: Self-assessment (1-2 weeks).
- Tip: For software as a medical device (SaMD), refer to the draft guidance (October 2025) for classification.
Step 2: Appoint an Authorized Indian Agent (AIA) for Foreign Manufacturers
- Indian manufacturers skip this; foreign entities must appoint an AIA via a notarized/apostilled Power of Attorney (PoA).
- AIA Requirements: Valid wholesale license (Forms 20B/21B) or MD-42 registration; acts as liaison for all CDSCO interactions.
- 2025 Update: New “Subsequent Importer” option allows multiple AIAs for the same device via the online portal (effective September 2025), streamlining multi-distributor imports.
- Documents Needed:
- PoA from manufacturer.
- AIA’s license copy and constitution details.
- Timeline: Before application (1 week).
Step 3: Prepare and Submit Application for Registration Certificate (RC)
The RC registers the device and manufacturing site with CDSCO, confirming compliance with Essential Principles of Safety and Performance (Schedule M-III).
- Application Form: MD-41 (via SUGAM portal).
- Process:
- Register/login to SUGAM; create organization profile.
- Upload technical dossier in Common Submission Dossier (CSD) format.
- CLA reviews (may include Notified Body audit for Class A/B or site inspection for C/D).
- Approval issues MD-42 (valid 5 years; renewable).
- Key Documents (Notarized/Apostilled):
- Device description, intended use, and labeling (per Rule 44).
- Quality Management System (QMS) certificate (ISO 13485 or equivalent).
- Free Sale Certificate (FSC) from country of origin + USA/UK/EU/Canada/Japan/Australia (for A/B; clinical data for C/D if no FSC).
- Risk management file (ISO 14971), biocompatibility/performance reports.
- For IVDs: Clinical performance evaluation (MD-24/25) or new IVD permission (MD-28/29).
- 2025 Update: Auto-generated Market Standing/Non-Conviction Certificates and Neutral Codes via portal (April 2025).
- Fees (per Fourth Schedule, amended 2022; in INR, approx. USD equivalent): Class Per Site Per Device A/B (Non-IVD) $1,000–2,000 $500–1,000 A/B (IVD) $1,000 $1,000 C/D (Non-IVD) $3,000 $1,500 C/D (IVD) $3,000 $1,500
- Timeline: 9 months max (shorter for low-risk: 4-8 weeks); extensions for queries/inspections.
Step 4: Apply for Import License (IL)
Post-RC, apply for IL to import for sale/distribution.
- Application Form: MD-14 (via SUGAM; issues MD-15).
- Process:
- Reference valid RC (MD-42).
- Submit import details (quantity, ports).
- CLA verifies; issues IL (valid 5 years, tied to RC).
- For testing/evaluation: Use MD-16/17 (limited quantity, no sale).
- For clinical trials: MD-18 (small quantities for life-threatening cases).
- 2025 Update: Brand Endorsement streamlined online for adding new brands to existing ILs; separate fees apply.
- Key Documents:
- Copy of RC (MD-42).
- FSC and QMS certificates (as in Step 3).
- Undertaking for post-market surveillance; residual shelf life compliance (min. 60% for >1-year shelf life).
- For subsequent importers: Covering letter with original IL details + manufacturer undertaking (no major changes).
- Fees: Same as RC (site + per device).
- Timeline: 3 months max (2-3 months typical).
Step 5: Customs Clearance and Import Execution
- Obtain No Objection Certificate (NOC) from CDSCO Port Office post-IL.
- Declare via ICEGATE (e-SANCHIT for paperless); comply with Unique Device Identification (UDI) labeling (mandatory since 2021).
- Ports: Any notified port; storage/distribution from registered premises.
- Residual Shelf Life Rule: Min. 40-60% remaining on import date.
- Re-Import: Allowed with Port Office approval and testing if needed.
Step 6: Post-Import Compliance and Renewals
- Labeling/Stickering: Add India-specific info (e.g., importer details) at licensed warehouse; comply with Rule 44.
- Post-Market Surveillance: Report adverse events via MD Adverse Event Form (v1.2, 2024); annual safety updates.
- Renewals: Apply 6 months pre-expiry; pay retention fees (INR 1,000/device).
- Changes: Notify CDSCO for modifications (e.g., sterilization method change requires endorsement).
- 2025 Update: Outsourcing sterilization needs NOC (June 2025 guidance); enhanced traceability for high-risk devices.
- Inspections: Random by CLA/State Licensing Authority (SLA).
Special Cases in 2025
- Custom-Made Devices: Exempt from IL if per prescription for single patient; QMS still required.
- Donations/Small Quantities: NOC for charitable hospitals (no IL needed).
- Veterinary Devices: Separate licensing; NOC from Dept. of Animal Husbandry if no predicate.
- Exemptions: Non-sterile Class A (pre-2022); personal imports limited.
Challenges and Tips
- Common Pitfalls: Incomplete dossiers, mismatched classifications, delayed responses to queries.
- Costs: Beyond fees, expect $5,000–20,000 for audits/consultants.
- Total Timeline: 6–12 months end-to-end.
- Consult CDSCO FAQs (July 2025 Addendum) or a regulatory expert. For updates, visit cdsco.gov.in.
This process fortifies patient safety while enabling market access. Always verify latest notifications on the SUGAM portal.