MD-26 Explained: Application Form for Permission to Import or Manufacture Novel (New) Medical Devices in India

MD-26 Explained – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the official application form submitted to the Central Licensing Authority (CLA) of the Central Drugs Standard Control Organisation (CDSCO) when seeking permission to import or manufacture a novel medical device (also called an investigational medical device or new medical device).

A “novel” or “new” device is one that does not have a predicate device in India. A predicate device is an already approved (licensed) device in India with similar intended use, material, design, and technology characteristics. Without a predicate, the device cannot follow the standard import/manufacturing license pathway (e.g., Form MD-14 → MD-15 for existing devices). Instead, it requires special prior permission due to the need for higher scrutiny on safety, performance, and efficacy.

Key Purpose of Form MD-26

• It serves as the application to request permission for importing or manufacturing the device for sale or distribution (commercial purposes).
• Upon successful review, CDSCO grants permission in Form MD-27.
• This permission is a prerequisite before applying for the full import license (MD-15) or manufacturing license (MD-5/MD-9) in relevant forms.
• It applies across all risk classes (A to D), though higher-risk (C/D) devices face more rigorous evaluation, often including clinical data or investigations.

When to Use Form MD-26

• For innovative devices with no equivalent (predicate) approved in India.
• For devices claiming new intended use, new population, major design/material change, or those lacking substantial equivalence.
• Often used for investigational medical devices (IMDs) or new in vitro diagnostic (IVD) devices.
• If clinical investigation is needed first, obtain a test license (MD-13/MD-17) to generate data, then apply via MD-26.

Submission & Process

• Submit online via the SUGAM portal (cdscomdonline.gov.in) or NSWS portal.
• Submitted by an Indian Authorized Agent (for imports) or the manufacturer (for local manufacture).
• CDSCO reviews the application, may refer to a Subject Expert Committee (SEC) for novel/high-risk cases, raise queries, or require additional data (e.g., clinical evidence).
• Timeline: Variable, often 6–12+ months depending on complexity, queries, and SEC involvement.

Required Documents (Typical Checklist from CDSCO)

From official CDSCO checklists (e.g., for MD-26 applications):

• Cover letter.
• Duly filled Form MD-26.
• Fees challan/receipt.
• Justification for proposed risk class + supporting documents.
• Regulatory status/approval from reference countries (e.g., USA, EU, UK, Canada, Japan, Australia) with notarized copies.
• Design analysis data: inputs/outputs, verification/validation reports.
• Essential Principles checklist for safety/performance.
• Device specifications, test protocols, and reports (mechanical, electrical, reliability, software validation, etc.).
• Stability study data (if applicable).
• Risk management report.
• Biocompatibility and animal performance data (as applicable).
• Proposed labeling/IFU.
• If device contains a drug: Approval status in India or toxicology/pharmaceutical data.
• Clinical investigation data (from India or abroad, if any).

Fees

As per the Second Schedule of MDR 2017 (approximate; confirm on portal):

• Varies by class and device (often aligned with import/manufacturing fees: $1,000–$3,000 per site + per-device fees).
• Additional for processing or retention.

After MD-26 Approval

• Receive Form MD-27 (permission).
• Use MD-27 to apply for full import license (MD-15 via MD-14) or manufacturing license (MD-5/MD-9 via MD-3/MD-7).
• Permission may include conditions (e.g., post-market surveillance, limited indications).

Important Notes (2026 Context)

• For software as a medical device (SaMD/SiMD) or IVDs, similar pathways apply (MD-26/MD-27 for IMDs; MD-28/MD-29 for new IVDs).
• Recent guidance (e.g., on medical device software, 2025 drafts) emphasizes this for novel tech.
• Always check the latest on cdsco.gov.in or SUGAM portal, as checklists/fees evolve.

Form MD-26 is the gateway for innovative devices to enter the Indian market, ensuring thorough evaluation before commercialization.

By Sam Michael

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FAQ Schema

Question: What is Form MD-26 used for? Answer: It is the application form submitted to CDSCO’s Central Licensing Authority for permission to import or manufacture a novel medical device that lacks a predicate (equivalent approved device) in India.

Question: What form is issued after MD-26 approval? Answer: Permission is granted in Form MD-27, which is required before applying for full import (MD-15) or manufacturing (MD-5/MD-9) licenses.

Question: When is MD-26 required instead of MD-14? Answer: When the device has no predicate in India (no similar approved device for substantial equivalence), often for innovative, investigational, or first-of-its-kind devices.

Question: Does MD-26 apply to all risk classes? Answer: Yes, across Class A to D, though higher-risk devices require more extensive data (e.g., clinical evidence, risk analysis).

Review Schema

Item Reviewed: CDSCO Form MD-26 for Novel Medical Devices Reviewer: Sam Michael Review Rating: 4.6/5 Review Body: MD-26 is the critical entry point for innovative devices without predicates—well-defined process with detailed documentation needs, leading to MD-27 permission. Essential for market access in India’s regulated medtech space; always pair with latest CDSCO checklists.