Form MD-26 is used under the Medical Devices Rules, 2017 for permission to import or manufacture new medical devices or those without a predicate device in India. It leads to Form MD-27 approval. Unlike Form MD-14 (for reference country approved devices), MD-26 involves stricter scrutiny for novel or unapproved devices.
Who Needs Form MD-26
- Importers or manufacturers introducing a medical device not previously approved in India or without substantial equivalence to an existing predicate device.
- Applies to all risk classes (A, B, C, D), especially higher-risk or innovative technologies.
Key Documents Required
- Form MD-26 – Completed application with device details.
- Power of Attorney – From foreign manufacturer to Indian agent (notarized/apostilled).
- Device Master File (DMF) – Comprehensive technical dossier including design, materials, manufacturing process, risk analysis, and clinical data.
- Plant Master File (PMF) – Details of manufacturing site and quality systems.
- ISO 13485 Certificate – For the manufacturing site.
- Clinical Investigation Report / Clinical Evaluation – Substantial evidence of safety and performance (more rigorous for new devices).
- Labeling and Instructions for Use – Compliant with Indian standards.
- Undertakings and Declarations – On compliance, post-market surveillance, and adverse event reporting.
- Test Reports – Biocompatibility, sterility, electrical safety, and performance testing from accredited labs.
Additional requirements may include stability data, sterilization validation, and reference to international standards (ISO, IEC, etc.).
Fees
Fees are higher than standard applications due to the novelty review. Exact amounts are listed in the Second Schedule of MDR 2017 (updated periodically). Payment is online via SUGAM portal.
Submission Process on SUGAM Portal
- Log in to https://cdscoonline.gov.in.
- Select Medical Devices department and Form MD-26.
- Fill all sections with accurate device classification, intended use, and specifications.
- Upload all supporting documents in PDF format.
- Pay applicable fees.
- E-sign with DSC and submit.
- Track status and respond to queries within stipulated timelines (typically 30 days).
Timelines and Validity
- Review process is more extensive and may take several months due to expert committee evaluation.
- Approved permission (Form MD-27) allows import/manufacturing with conditions.
- Post-approval, devices are subject to post-market surveillance and periodic reporting.
Important Notes:
- Classify the device correctly using CDSCO guidance to determine the appropriate route (MD-14 vs MD-26).
- Novel devices often require additional clinical data or local clinical investigation.
- Engage a regulatory consultant for complex submissions to minimize queries and rejections.
Always verify the latest requirements on the official CDSCO SUGAM portal or gazette notifications, as rules are periodically updated. For high-risk or innovative devices, early engagement with CDSCO is recommended.