Import Authorization for Novel Medical Devices IVDs (Forms MD-26, MD-27)
CDSCO Regulatory Support for Novel Medical DevicesIntroducing an innovative medical device into the Indian market may require a specialised regulatory assessment where the proposed device does not have a predicate medical device.
Under the Medical Devices Rules, 2017, a specific regulatory pathway is available for obtaining
permission to import or manufacture for sale or distribution a medical device that does not have
a predicate medical device.
The application and approval process involves:
Form MD-26 – Application for Grant of Permission
Form MD-27 – Permission Granted by the Central Licensing Authority
MDR Consultants provides regulatory and documentation support to manufacturers and authorised representatives navigating this specialised CDSCO pathway.
Understanding Form MD-26 and Form MD-27
What is Form MD-26?
Form MD-26 is the prescribed application for seeking permission to import or manufacture for sale or distribution a medical device that does not have a predicate medical device.
The application is submitted to the Central Licensing Authority (CLA) along with the applicable fee and supporting documents prescribed under the Medical Devices Rules, 2017.
The application includes information relating to the applicant, manufacturer, manufacturing site and medical device proposed for import or manufacture.
What is Form MD-27?
Form MD-27 is the permission granted by the Central Licensing Authority for the import or manufacture for sale or distribution of a medical device that does not have a predicate medical device, subject to the applicable provisions and conditions.
In simple terms:
MD-26 = Application for Permission
MD-27 = Regulatory Permission
Who Can Apply Under the MD-26 / MD-27 Pathway?
The regulatory pathway may be relevant to eligible applicants seeking permission to:
- Import a medical device for sale or distribution in India; or
- Manufacture a medical device for sale or distribution in India,
where the device does not have a predicate medical device and the applicable requirements of the Medical Devices Rules, 2017 are fulfilled.
where the device does not have a predicate medical device and the applicable requirements of the Medical Devices Rules, 2017 are fulfilled.
Indian Medical Device Manufacturers
Manufacturers seeking regulatory permission for an innovative medical device intended to be manufactured and introduced into the Indian market.
Authorised Indian Representatives / Import Applicants
Eligible Indian entities representing overseas manufacturers and seeking permission to
import a medical device into India.
The appropriate applicant structure and regulatory responsibilities should be assessed
before submission.
MD-26 & MD-27 Regulatory Process
The regulatory process may generally involve the following stages:
Assess the Medical Device
The regulatory process begins with a detailed assessment of the proposed medical device.
Key information that may require review includes:
• Generic name of the device
• Model or variant details
• Intended use
• Indications and target users
• Device technology
• Mode of operation
• Materials, where applicable
• Sterile or non-sterile status
• Shelf life, where applicable
• Proposed risk classification
Assess the Availability of a Predicate Device
An important aspect of this pathway is determining whether an appropriate predicate medical device exists.
The regulatory assessment should consider the characteristics and intended use of the proposed device and evaluate the availability of an appropriate predicate device.
Where the device is determined to fall within the pathway applicable to medical devices without a predicate device, the regulatory submission strategy should be developed accordingly.
Determine the Applicable Regulatory Strategy
The regulatory strategy should be established before preparing the application.
This assessment may include:
• Device classification
• Intended use
• Novelty of the technology
• Availability of comparable devices
• Regulatory status in other jurisdictions
• Available safety and performance evidence
• Clinical evidence, where applicable
• Applicable testing or evaluation requirements
A properly planned regulatory strategy helps identify the information and documentation
required for the proposed application.
Prepare the Technical Documentation
The technical documentation should provide sufficient information about the medical
device and support its regulatory evaluation.
Depending on the nature of the device and applicable requirements, documentation may
include:
• Device description
• Intended use
• Design information
• Manufacturing information
• Material specifications, where applicable
• Product specifications
• Performance characteristics
• Verification and validation information
• Packaging details
• Labelling
• Instructions for Use
• Shelf-life information, where applicable
The scope and level of documentation should be determined based on the specific device
and applicable CDSCO requirements.
Compile Safety and Performance Evidence
The regulatory application should be supported by appropriate evidence relating to the
safety and performance of the medical device.
Depending on the nature and risk profile of the device, relevant evidence may
include:
• Bench testing
• Verification data
• Validation data
• Performance testing
• Biocompatibility information, where applicable
• Electrical safety and electromagnetic compatibility information, where applicable
• Software validation, where applicable
• Clinical evidence, where applicable
• Other device-specific supporting data
The evidence package should be appropriate to the device technology, intended use and
regulatory requirements.
Prepare Risk Management Documentation
Risk management is an important component of medical device regulatory
documentation.
The risk management process should address the identification and evaluation of
potential hazards associated with the device and the measures implemented to control
associated risks.
Risk management documentation may address:
• Identification of hazards
• Estimation and evaluation of risks
• Risk control measures
• Assessment of residual risks
• Evaluation of benefit-risk considerations, where applicable
Where ISO 14971 is used as part of the manufacturer's risk management framework, the
documentation should be appropriately aligned with the device and its intended use.
Quality Management System Documentation
The manufacturer should maintain an appropriate quality management system in accordance
with applicable regulatory requirements.
Relevant quality documentation may include information relating to:
• Design controls
• Manufacturing controls
• Supplier controls
• Quality control procedures
• Complaint handling
• Corrective and preventive action
• Document control
• Change management
Evidence relating to an established quality management system, including ISO 13485
certification where applicable, may form part of the supporting regulatory
documentation.
Prepare the Form MD-26 Application
Once the regulatory strategy and supporting documentation are in place, the application
can be prepared in Form MD-26.
The prescribed form includes information relating to:
• Applicant details
• Nature and constitution of the applicant
• Corporate or registered office
• Manufacturing site or authorised agent details, as applicable
• Manufacturer and manufacturing site details
• Medical device details
• Applicable fee
• Supporting documents required under the applicable provisions
Before submission, the application and technical dossier should be reviewed for
completeness and consistency.
Submit the Application to CDSCO
The MD-26 application is submitted through the applicable CDSCO regulatory system along
with the required documents and applicable government fee.
Before submission, it is advisable to verify:
• Accuracy of applicant information
• Correct manufacturer details
• Device details and intended use
• Classification justification
• Completeness of technical documentation
• Supporting safety and performance evidence
• Regulatory status documentation, where applicable
• Consistency between forms and supporting documents
CDSCO Regulatory Review
The Central Licensing Authority reviews the application and supporting documentation in
accordance with the applicable regulatory provisions.
During the review, additional clarification, documents, justification or
supporting information may be requested.
The nature and extent of regulatory review may depend on factors including:
• Nature of the technology
• Intended use
• Risk associated with the device
• Novelty of the device
• Available scientific evidence
• Safety and performance information
• Completeness of the submitted documentation
Response to Regulatory Queries
Where clarification or additional information is requested during the regulatory review,
responses should be prepared carefully and supported with relevant evidence.
A well-structured response should:
• Address the specific query raised
• Provide scientifically and technically appropriate clarification
• Include relevant supporting documentation
• Maintain consistency with the original submission
• Clearly identify any revised or additional information
Effective regulatory query management is important during the review process.
Grant of Permission in Form MD-27
Where the Central Licensing Authority is satisfied with the application and supporting
documentation in accordance with the applicable requirements, permission may be granted
in Form MD-27.
The permission is subject to the applicable provisions of the Medical Devices Rules,
2017 and any conditions associated with the regulatory approval.
Applicants should review the scope and conditions of the granted permission before
proceeding with commercial activities.
Key Documentation Areas for an MD-26 Application
The exact documentation requirement may vary depending on the nature of the medical device and the regulatory assessment. A typical regulatory dossier may involve the following areas:
| Sr. No. | Documentation Area |
|---|---|
| 1 | Form MD-26 Application |
| 2 | Cover Letter |
| 3 | Applicant Details |
| 4 | Manufacturer and Manufacturing Site Details |
| 5 | Device Description |
| 6 | Intended Use |
| 7 | Device Classification and Supporting Justification |
| 8 | Predicate Device Assessment |
| 9 | Technical Documentation |
| 10 | Device Specifications |
| 11 | Safety and Performance Evidence |
| 12 | Risk Management Documentation |
| 13 | Quality Management System Documentation |
| 14 | Labelling and Instructions for Use |
| 15 | Regulatory Status in Other Jurisdictions, where applicable |
| 16 | Applicable Fee Documentation |
| 17 | Additional Documents as Required by CDSCO |
How MDR Consultants Can Help
MDR Consultants provides regulatory and documentation support for eligible institutions seeking assistance with the MD-18 and MD-19 regulatory pathway.
Our support services include:
- Regulatory Applicability Assessment: Assessment of the proposed case against the relevant provisions of the Medical Devices Rules, 2017 and evaluation of the applicability of the MD-18/MD-19 pathway.
- Device Eligibility Review: Review of the available information relating to the investigational medical device, including its regulatory status and approval in the country of origin.
- Documentation Assessment: Identification and organisation of relevant medical, institutional, device, manufacturer and regulatory documentation required to support the application.
-
MD-18 Application Support:
Assistance with organising the information and documentation required for preparation of the application in Form MD-18. - Regulatory Documentation Coordination: Support in ensuring consistency between patient treatment information, medical justification, device details and supporting institutional documentation.
- CDSCO Submission Support: Assistance with the applicable regulatory submission process and coordination of the documentation package.
- Query and Clarification Support: Assistance in reviewing regulatory queries or requests for clarification and coordinating appropriate responses with the concerned stakeholders.
- MD-19 Licence Stage Support: Regulatory support throughout the application review and licensing process, including assistance in understanding the scope and conditions of the licence.
MDR Consultants – MD-18 & MD-19 Regulatory Support
MDR Consultants provides professional regulatory support for eligible Government hospitals and statutory medical institutions involved in applications for the import of investigational medical devices for patient treatment.
