New Medical Device in India: When MD-22, MD-23, MD-26, and MD-27 Apply

India’s Medical Devices Rules, 2017 (MDR 2017) has a distinct regulatory pathway for Devices classified as New Medical Devices — a category that carries additional scrutiny, documentation requirements, and in many cases, clinical data obligations. Navigating this pathway requires a clear understanding of four specific forms: MD-22, MD-23, MD-26, and MD-27.

This article explains what qualifies as a New Medical Device under Indian law, which form applies to which situation, what documentation is required, and how to plan your regulatory strategy accordingly.

What Is a New Medical Device under MDR 2017?

MDR 2017 defines a New Device as one that:

1. Is not approved or available for use in India before the date of notification under MDR 2017
2. Uses a new technology or has a new intended use that has not previously been approved in India
3. Is not included in the list of devices regulated under the Drugs and Cosmetics Act prior to MDR 2017

The ‘New Device’ designation is not simply about whether a device is innovative globally. A device that has been marketed in the US and EU for a decade can still qualify as a New Device in India if CDSCO has not previously approved it for the Indian market. Always verify your device’s New Device status with a qualified Indian regulatory consultant before determining your filing strategy.

The Four Forms: When Each Applies

Table 1

MD-22: Import Permission for Clinical Investigation

When Is MD-22 Used?

MD-22 is the application form filed by a sponsor (foreign manufacturer, Indian sponsor, or CRO) seeking permission from the Central Licensing Authority to conduct a clinical investigation of an investigational Medical device in India — evaluating safety and performance in Indian patients, typically as a precursor to full market approval. Permission is granted in Form MD-23.

Key Requirements for MD-22 (per official CDSCO checklist)

• Regulatory status of the device, if approved by the national regulatory authority of the UK, US, Australia, Canada, or Japan — with a notarized copy of the approval letter (note: this list is UK/US/Australia/Canada/Japan specifically, not a general “IMDRF-member country” reference — EU/CE is not named in the official checklist)
• Design analysis data: design input/output/control documentation, design verification and validation reports
• Essential Principles checklist demonstrating conformity to device safety and performance requirements
• Device specifications, test parameters, reference protocols, and test reports for the finished device
• Applicable mechanical, electrical, reliability, software verification/validation, performance, and ex vivo test data
• Stability study data (if available)
• Risk Management Report (this is the correct requirement — not specifically framed as “ISO 14971,” though that standard is commonly used to produce it)
• Biocompatibility and animal performance study data, where applicable
• Proposed labelling information
• A written undertaking to conduct post-marketing clinical investigation per a CLA-approved protocol

MD-23: Import License for New Devices with Reference Country Approval

When Is MD-23 Used?

Form MD-23 is the License to Conduct Clinical Investigation of an Investigational Medical Device, granted by the Central Licensing Authority (CLA) in response to an application filed in Form MD-22.

When Is MD-23 Used?
MD-23 is used when a sponsor/investigator wants to conduct a clinical investigation (clinical trial) of an investigational medical device in India — i.e., before the device has any marketing history in India and clinical data is still being generated. It authorizes the conduct of the trial, not the import or sale of a finished, market-ready product.

Process:

1. Applicant files Form MD-22 via the SUGAM portal
2. CLA reviews the protocol, investigator qualifications, and site details
3. On approval, permission is granted in Form MD-23

This form has no direct relationship to “reference country approval” or import licensing for globally-approved devices.

For MD-23 applications, CDSCO’s Technical Expert Committee (TEC) plays a central role. The TEC may request additional Indian-specific clinical data or bridging studies if it concludes that existing international data is not sufficient to support approval for the Indian population. Early TEC engagement through a pre-submission meeting can save significant time.

MD-26: Manufacturing Permission for Clinical Investigation

When Is MD-26/MD-27 Used?

Form MD-26 is the application filed with the Central Licensing Authority (CLA) requesting permission to import or manufacture a “new” medical device that has no existing predicate device in India — i.e., no comparable device already approved/marketed in the Indian market against which it can claim substantial equivalence. It is filed after the required clinical investigation has been completed (or after the CLA has determined clinical investigation can be waived.

Permission is granted by the CLA in Form MD-27.

This is the pathway most relevant to established international manufacturers bringing a genuinely novel, globally approved device to India, and to Indian MedTech companies whose device has no domestic precedent.

Process Flow

1. Determine the device has no predicate in India (novel device or new intended use)
2. Conduct clinical investigation under Form MD-22 → MD-23, unless the waiver criteria below apply
3. File the commercialization application in Form MD-26
4. A Subject/Special Expert Committee (SEC) reviews the technical dossier and recommends approval or additional clinical trials
5. CLA grants Form MD-27, permitting import or manufacture for sale/distribution

Clinical Investigation Waiver (the “reference country” mechanism)

Under Chapter VIII of MDR 2017, clinical investigation is not required for a Class B, C, or D device without a predicate device if:

• The device is approved by the national regulatory authority of the UK, US, Australia, Canada, or Japan, and
• It has been marketed for at least two years in that country, and
• The CLA is satisfied with the submitted safety and performance data

This is the correct basis for what your original document called “reference country approval” — it applies specifically to the MD-26/MD-27 pathway, not to MD-23.

Key Requirements for MD-26

• Full clinical data or Clinical Evaluation Report (CER) demonstrating safety and performance — or evidence supporting the waiver criteria above in place of fresh clinical investigation
• Regulatory approval status and notarized approval letter from the reference country’s national regulatory authority
• Post-market surveillance data from the reference country, including complaints and adverse event history, covering the marketing period there
• Design analysis data: design input/output/control documentation, verification and validation reports
• Essential Principles checklist demonstrating conformity to safety and performance requirements
• Risk management report/file
• Evidence or rationale addressing any physiological/epidemiological differences relevant to the Indian population, where applicable
• Device Master File and (for imports) notarized overseas manufacturing site registration
• Proposed labelling and Instructions for Use

Post-Grant Obligations Once MD-27 Is Issued

• Periodic Safety Update Report (PSUR): every 6 months for the first 2 years, then annually for the following 2 years
• Suspected unexpected serious adverse events reported within 15 days
• Continued compliance with Chapter VII/VIII conditions of MDR 2017

Strategic Considerations for New Device Applicants

4. Determine New Device status early: Before committing to MD-22/MD-23/MD-26/MD-27, confirm with a regulatory expert whether your device truly qualifies as a New Device under MDR 2017 — unnecessary classification as a New Device significantly extends your timeline
5. Reference country data strength matters: For MD-23, the quality and volume of your international clinical data directly determines whether CDSCO will request bridging studies
6. Plan for TEC timelines: Technical Expert Committee reviews add 3–6 months to standard approval timelines for New Devices
7. Engage CDSCO early: Pre-submission meetings (available for New Device applications) provide regulatory guidance that can shape your dossier and reduce queries
8. Budget for clinical investigation in India: For truly novel devices without reference country approval, plan for 18–36 months from clinical investigation approval to full market license

Conclusion

The New Medical Device pathway under MDR 2017 — governed by MD-22, MD-23, MD-26, and MD-27 — reflects CDSCO’s commitment to ensuring that novel devices reaching Indian patients have been adequately evaluated for safety and performance. For companies with well-supported global clinical data, the pathway is navigable. For those bringing truly novel devices, early regulatory strategy planning is essential.

Ready to get started?  Book a regulatory pathway discussion for your New Device. Contact CliniExperts: cliniexperts.com/india-regulatory-services/medical-device-for-importer/ | contact@cliniexperts.com