New Medical Device Import License (MD 26/27)
Medical device manufacturers planning to introduce a new medical device without a predicate device in India may need to follow a specific regulatory pathway under the Medical Devices Rules, 2017.
Form MD-26 is used to apply to the Central Licensing Authority for permission to import or manufacture a medical device that does not have a predicate device, while Form MD-27 is the permission granted by the Central Licensing Authority when the applicable requirements are satisfied.
Understanding the MD-26 and MD-27 process is important for foreign manufacturers, Indian authorised agents, and companies planning to introduce innovative medical devices into the Indian market.
In this guide, we explain what MD-26 and MD-27 are, who can apply, key documentation, the application process, and how Operon Strategist can support your CDSCO regulatory requirements.
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What Is an MD-26 License?
MD-26 is the application submitted to the Central Licensing Authority for permission to import or manufacture a medical device that does not have a predicate device.
Under the Medical Devices Rules, 2017, manufacturers and authorised agents seeking to introduce such devices must provide technical, safety, performance, and clinical information as applicable.
The purpose of this regulatory assessment is to allow the authorities to evaluate whether the new medical device is safe, effective, and suitable for its intended use.
For imported medical devices, the application is submitted by the authorised Indian agent on behalf of the foreign manufacturer, subject to the applicable requirements.
What Is an MD-27 License?
MD-27 is the permission issued by the Central Licensing Authority following the review of an MD-26 application for a medical device without a predicate device.
In simple terms:
MD-26 = Application
MD-27 = Permission
Therefore, MD-26 and MD-27 should be considered together as part of the regulatory pathway for eligible new medical devices without a predicate device.
Who Needs MD-26 and MD-27?
The MD-26 and MD-27 pathway applies to medical devices that do not have a predicate device in India and are proposed to be imported or manufactured in India.
This pathway may be relevant to:
- Foreign medical device manufacturers entering India with a new device
- Indian manufacturers developing innovative medical devices
- Companies introducing a device for which no predicate device is available
- Manufacturers developing new technologies or novel medical devices
- Indian authorised agents representing foreign medical device manufacturers
The exact regulatory requirements depend on the device, its intended use, risk classification, technology, clinical evidence, and applicable provisions of the Medical Devices Rules, 2017.
What Is a Predicate Device?
A predicate device is an existing medical device that can serve as a reference for the applicable regulatory pathway.
When a new medical device does not have a predicate device, the manufacturer may need to provide additional evidence to demonstrate the device’s safety and performance.
This is one of the key reasons why the MD-26 and MD-27 pathway requires detailed technical and clinical information.
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MD-26 and MD-27 Eligibility
Before beginning an MD-26 application, the manufacturer should evaluate whether:
- The product qualifies as a medical device under Indian regulations.
- The device has an applicable predicate device in India.
- The device classification has been correctly determined.
- The proposed indications and intended use are clearly defined.
- Required technical documentation is available.
- Applicable clinical or performance evidence is available.
- The foreign manufacturer has an appropriate Indian authorised agent, where required.
A regulatory assessment before submission can help identify documentation gaps and determine the appropriate pathway.
Documents Required for MD-26 Application
The documentation required for an MD-26 application depends on the nature and risk classification of the medical device.
The application may require information and evidence covering areas such as:
- Applicant and manufacturer details
- Details of the Indian authorised agent
- Device description
- Intended use
- Indications for use
- Device classification
- Manufacturing site details
- Device specifications
- Design information
- Design verification and validation
- Risk management documentation
- Essential Principles checklist
- Performance evaluation
- Clinical investigation or clinical data, where applicable
- Biocompatibility information, where applicable
- Software documentation, where applicable
- Stability and shelf-life data, where applicable
- Packaging information
- Labelling
- Instructions for use
- Test reports
- Regulatory approvals or marketing authorisations from other countries, where applicable
- Quality management system documentation
The exact document set should be determined based on the specific medical device and the applicable CDSCO requirements.
MD-26 and MD-27 Application Process
The MD-26 and MD-27 process can generally be approached through the following stages.
Step 1: Determine Whether the Device Has a Predicate
The first step is to establish whether the proposed medical device has an applicable predicate device.
If there is no predicate device, the MD-26/MD-27 pathway may apply.
Step 2: Determine Device Classification
The medical device should be classified according to the applicable risk classification requirements under the Medical Devices Rules, 2017.
Correct classification is important because it influences the regulatory requirements and supporting evidence.
Step 3: Review the Regulatory Requirements
The manufacturer should identify the applicable technical, clinical, quality, and administrative documentation required for the submission.
Step 4: Prepare the Technical Documentation
The technical file should contain sufficient evidence to demonstrate the safety, performance, and suitability of the device for its intended purpose.
Step 5: Prepare Form MD-26
The applicant prepares and submits the MD-26 application with the required supporting documents and applicable fees.
For an imported device, the Indian authorised agent coordinates the application with the Central Licensing Authority.
Step 6: Regulatory Review
The Central Licensing Authority reviews the application and supporting documentation.
The authority may raise queries or request additional information, clarification, testing, or evidence depending on the device.
Step 7: Respond to Regulatory Queries
The applicant should provide complete and technically appropriate responses to regulatory queries within the applicable timelines.
Step 8: Obtain MD-27 Permission
If the application satisfies the applicable regulatory requirements, the permission is granted in Form MD-27.
This allows the applicant to proceed according to the scope and conditions of the permission.
Why Is MD-26 and MD-27 Approval Important?
The MD-26 and MD-27 pathway provides a regulatory mechanism for evaluating medical devices that do not have a predicate device.
For manufacturers, completing the process helps establish a regulatory pathway for introducing innovative medical devices into the Indian market.
It also allows the regulatory authority to evaluate relevant evidence relating to:
- Safety
- Performance
- Intended use
- Risk
- Clinical suitability
- Technical characteristics
- Quality
- Manufacturing controls
MD-26 and MD-27 vs Standard Medical Device Registration
The MD-26 and MD-27 pathway should not be treated as a generic medical device registration process.
Its key characteristic is that it applies to a medical device without a predicate device.
This means the regulatory strategy should be developed around the specific characteristics and evidence requirements of the new device.
For this reason, manufacturers should assess the regulatory pathway before preparing the final application.
How Operon Strategist Can Help With MD-26 and MD-27
Operon Strategist provides regulatory consulting services for medical device manufacturers planning to enter the Indian market.
Our support for the MD-26 and MD-27 pathway can include:
- Regulatory pathway assessment
- Medical device classification
- Predicate device assessment
- Regulatory gap assessment
- Technical documentation support
- Clinical documentation support
- Risk management documentation
- Application preparation
- MD-26 submission support
- Regulatory query response support
- MD-27 permission support
- CDSCO regulatory coordination
Our team works with manufacturers and medical device companies to understand their products, identify applicable regulatory requirements, prepare documentation, and support the submission process.
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FAQ's
What is MD-26 in medical device regulation?
MD-26 is the application form used to seek permission from the Central Licensing Authority to import or manufacture a medical device that does not have a predicate device.
What is MD-27 in medical device regulation?
MD-27 is the permission granted by the Central Licensing Authority for a medical device without a predicate device after the applicable regulatory assessment.
What is the difference between MD-26 and MD-27?
The simplest difference is:
MD-26 is the application, while MD-27 is the permission.
Who can apply for MD-26?
The applicable applicant depends on whether the device is being manufactured in India or imported. For imported medical devices, an authorised Indian agent can submit the application on behalf of the foreign manufacturer, subject to the applicable regulatory requirements.