The Central Drugs Standard Control Organisation (CDSCO) regulates the import of medical devices into India under the Medical Devices Rules, 2017 (with ongoing amendments as of 2026, including updates on perpetual validity for licenses subject to retention fees and pathways for subsequent importers). The required forms depend on whether the device is “existing” (notified with predicate devices) or “new” (no predicate device, often requiring special permission).
Forms for Existing (Notified) Medical Devices
For most imported medical devices across risk classes A to D (low to high risk), the standard process uses:
- Application Form: MD-14 — Submitted by an authorized Indian agent to apply for the import license.
- License/Permission Form: MD-15 — The actual import license issued by CDSCO upon approval.
This applies to notified devices (e.g., most Class B, C, D, and certain Class A sterile/measuring devices). Applications are filed online via the CDSCO’s SUGAM portal (cdscomdonline.gov.in). Recent CDSCO checklists confirm MD-14 for fresh or endorsement applications, leading to MD-15.
Forms for New Medical Devices (No Predicate Device)
For innovative or novel devices without a predicate (reference device) in India:
- Application Form: MD-26 — For permission to import or manufacture new devices.
- Permission Form: MD-27 — The approval/permission granted by CDSCO.
These are used when the device lacks substantial equivalence to existing ones, often requiring more extensive data (e.g., clinical evidence, risk analysis).
Special Cases and Additional Forms
- For training, demonstration, clinical investigation, or test purposes: Apply in Form MD-16; license issued in Form MD-17.
- For investigational devices to government hospitals/statutory institutions for patient treatment: Apply in Form MD-18; permission in Form MD-19.
- For small quantities for personal use: Apply in Form MD-20; permission in Form MD-21.
- Subsequent importer (for devices already licensed by another importer): Recent 2025-2026 pathways allow applications in Form MD-14 leading to MD-15 with reduced documentation.
Step-by-Step Procedure to Obtain Import License
- Classify the Device — Determine risk class (A-D) via CDSCO guidelines. Check if it’s notified/regulated (mandatory registration/import license for most except non-sterile, non-measuring Class A).
- Appoint an Authorized Indian Agent — Foreign manufacturers cannot apply directly. Grant power of attorney (authenticated/notarized/apostilled) to an Indian agent with wholesale/manufacturing license (e.g., Form MD-42 registration).
- Prepare and Submit Application — File via SUGAM portal in the relevant form (MD-14 for existing; MD-26 for new). Include supporting documents like:
- Covering letter
- Fee challan
- Power of attorney
- Free Sale Certificate/Marketing Authorization (from origin or GHTF countries like USA, EU, etc., notarized)
- Quality Management System certificates (e.g., ISO 13485)
- Plant Master File & Device Master File
- Labeling, risk analysis, stability data, etc.
- CDSCO Review & Approval — CDSCO evaluates (may include queries or audits). Approval email sent to registered ID; license (MD-15/MD-27) issued digitally. Rejection includes reasons.
Timeline: Typically 6-9 months, varying by complexity and queries. Fees: Around $1,000 USD (or equivalent INR) per manufacturing site + $50 USD per product (subject to updates; check SUGAM for current rates). Validity: Perpetual (as per recent amendments), but license retention fee due every 5 years to maintain.
Approval Process — If approved, receive MD-15 (or equivalent) via email. For new devices, MD-27 permission may precede full import license.
This process ensures safety, quality, and compliance for imported devices. Always verify latest requirements on the official CDSCO portal (cdsco.gov.in) or SUGAM, as guidelines evolve (e.g., 2025-2026 drafts on perpetual validity and simplified subsequent importer paths).
Frequently Asked Questions
- What forms are required for standard medical device import license? MD-14 (application) and MD-15 (license) for existing devices; MD-26 and MD-27 for new ones.
- What is the validity of the import license? Perpetual, subject to paying retention fees every 5 years.
- What documents are typically required? Power of attorney, Free Sale Certificate, QMS certificates, Plant/Device Master Files, labeling, and more (see CDSCO checklists).
- How long does it take? 6-9 months on average.
- What are the fees? Approximately $1,000 USD per site + $50 USD per product (or equivalent INR).
By Sam Michael
Follow us on X @realnewshubs and subscribe for push notifications.
Follow and subscribe us increase push notification.
FAQ Schema
Question: What forms are required for importing existing medical devices to India? Answer: Application in Form MD-14 and import license issued in Form MD-15.
Question: What forms apply to new medical devices without predicate? Answer: Application in Form MD-26 and permission in Form MD-27.
Question: Who can apply for the CDSCO import license? Answer: An authorized Indian agent on behalf of the foreign manufacturer, with power of attorney.
Question: What is the validity period of the import license? Answer: Perpetual, provided retention fees are paid every 5 years.
Review Schema
Item Reviewed: CDSCO Medical Device Import License Forms and Procedure Reviewer: Sam Michael Review Rating: 4.7/5 Review Body: Clear, structured guidance from CDSCO under Medical Devices Rules 2017—forms like MD-14/MD-15 remain standard for most imports, with MD-26/MD-27 for novel devices. Process is thorough but time-intensive; recent updates enhance flexibility for subsequent importers. Essential for compliance in India’s growing medtech market.