Manufacture Novel Medical Devices – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the prescribed application form submitted to the Central Licensing Authority (CLA) within the Central Drugs Standard Control Organisation (CDSCO). It is used to seek prior permission for importing or manufacturing a novel (new or investigational) medical device that does not have a predicate device already approved in India.
A predicate device is an existing licensed medical device in India with substantially equivalent intended use, technological characteristics, design, materials, and performance. Without one, the device cannot follow the routine licensing pathway (e.g., MD-14 → MD-15 for import of existing devices). Instead, CDSCO requires detailed pre-approval scrutiny to ensure safety, performance, and quality before commercialization.
Key Purpose of Form MD-26
- It initiates the process to obtain permission for import or manufacture of the novel device for sale or distribution (commercial purposes).
- Upon successful review, CDSCO issues permission in Form MD-27.
- Form MD-27 is a mandatory prerequisite before applying for the full import license (Form MD-15 via MD-14) or manufacturing license (Form MD-5/MD-9 via MD-3/MD-7).
- Applies to all risk classes (A to D), including investigational medical devices (IMDs) and new in vitro diagnostic (IVD) devices without predicates (for IVDs, a parallel MD-28/MD-29 pathway may apply in some cases).
When Form MD-26 Is Required
- Device has no predicate in India (first-of-its-kind, innovative design, new intended use, new population, or major changes lacking equivalence).
- For innovative technologies, software as/ in medical devices (SaMD/SiMD), or devices needing clinical evidence.
- If clinical investigation data is required first: Obtain test license (MD-16/MD-17 for import or MD-12/MD-13 for manufacture) to generate data, then submit in support of MD-26.
Submission Process
- Submit online via the SUGAM portal (cdscomdonline.gov.in) or NSWS portal.
- Filed by an Indian Authorized Agent (for foreign manufacturers) or the manufacturer (for local production).
- CDSCO reviews (may involve Subject Expert Committee for novel/high-risk cases), issues queries, or requests more data (e.g., clinical trials).
- Timeline: Typically 6–12+ months (varies by risk class, data completeness, and SEC involvement).
Required Documents (Typical Checklist from CDSCO)
Based on official checklists (e.g., from cdsco.gov.in and Fourth Schedule MDR 2017):
- Cover letter.
- Duly filled Form MD-26 (specimen proforma available on CDSCO site).
- Fees challan/receipt.
- Justification for proposed risk class + supporting rationale.
- Regulatory status/approvals from reference countries (USA, EU, UK, Canada, Japan, Australia) with notarized copies.
- Design analysis: Inputs/outputs, verification/validation reports.
- Essential Principles checklist for safety and performance.
- Device specifications, test protocols/reports (mechanical, electrical, reliability, software validation, etc.).
- Stability study data (if applicable).
- Risk management report (ISO 14971 compliant).
- Biocompatibility and animal performance data (as required).
- Proposed labeling/Instructions for Use (IFU).
- If device incorporates a drug: Approval status in India or toxicology/pharmaceutical data.
- Clinical investigation data (from India/abroad; local trials often needed if global data insufficient).
Fees
As per Second Schedule MDR 2017 (approximate; confirm on SUGAM portal):
- Varies by class and site/device (often $1,000–$3,000 per site + $50–$1,500 per device, aligned with import/manufacturing fees).
- Additional processing or retention fees apply post-approval.
After Submission
- CDSCO evaluates and may refer to experts.
- If approved: Permission granted in Form MD-27 (with possible conditions like post-market surveillance).
- If rejected: Reasons provided; resubmission possible with additional data.
- MD-27 enables full licensing; non-compliance can lead to suspension/cancellation.
Form MD-26 ensures rigorous pre-market evaluation for innovative devices, protecting public health while enabling access to new technologies in India.
By Mark Smith
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FAQ Schema
Question: What is Form MD-26? Answer: It is the application form submitted to CDSCO for permission to import or manufacture a novel medical device without a predicate in India.
Question: What happens after submitting Form MD-26? Answer: CDSCO reviews it; if approved, permission is granted in Form MD-27, allowing application for full import/manufacturing license.
Question: Who submits Form MD-26? Answer: An Indian Authorized Agent (for imports) or the manufacturer, via the SUGAM portal.
Question: Is clinical data always required for MD-26? Answer: Not always, but often needed for novel/high-risk devices; global data may suffice with local bridging if required.
Review Schema
Item Reviewed: CDSCO Form MD-26 for Novel Medical Devices Reviewer: Mark Smith Review Rating: 4.6/5 Review Body: Form MD-26 is the essential starting point for innovative devices lacking predicates—detailed documentation and review ensure safety before MD-27 permission. Critical step in India’s medtech regulation; use official portal for current checklists.