Medical Devices Without a Predicate Device in India: CDSCO Approval Under Rules 63–65

Introducing an innovative medical device into the Indian market requires careful assessment of the Medical Devices Rules, 2017 (MDR 2017) and the regulatory requirements of the Central Drugs Standard Control Organisation (CDSCO).

Where a medical device does not have a predicate medical device in India, a specific regulatory pathway is provided under Chapter VIII of the Medical Devices Rules, 2017. Rules 63, 64 and 65 establish requirements relating to permission for medical devices without a predicate device, new in vitro diagnostic medical devices (IVDs), and conditions attached to the permissions granted by the Central Licensing Authority.

For manufacturers and importers, understanding these provisions is essential for developing an appropriate clinical and technical documentation strategy and planning a compliant Indian market-entry pathway.

What Is a Medical Device Without a Predicate Device?

A predicate medical device is an existing medical device that can be used as the relevant regulatory reference for a new device under the applicable framework.

Where a proposed medical device does not have an applicable predicate device, the applicant may need to follow the pathway prescribed under Rule 63 of the MDR 2017, subject to the device's classification and the applicability of any exemption or special regulatory provision.

The pathway generally requires the applicant to provide appropriate technical, safety, performance and clinical information to enable the Central Licensing Authority to evaluate whether the device can be permitted for import or manufacture for sale or distribution in India.

Rule 63: Permission for Medical Devices Without a Predicate Device

Rule 63 establishes the procedure for obtaining permission to import or manufacture a medical device that does not have a predicate medical device.

Following the applicable clinical investigation requirements under Chapter VII, the applicant—being the authorised agent in the case of import or the manufacturer in the case of manufacture—submits an application in Form MD-26 to the Central Licensing Authority.

The application must be accompanied by:

• The applicable fee prescribed under the Second Schedule; and
• The information and documents specified in Part IV of the Fourth Schedule.

The exact documentation and evidence package should be determined according to the device, its risk classification, intended use, technology and applicable CDSCO requirements.

Relaxation of Clinical and Animal Data Requirements

Rule 63 provides regulatory flexibility in specified circumstances. Where a device is intended for conditions involving, for example:

• Life-threatening or serious diseases or conditions;
• Diseases or conditions of special relevance to the Indian health scenario;
• National emergencies;
• Extreme urgency;
• Epidemics; or
• Conditions for which there is no available therapy,

the Central Licensing Authority may, where appropriate, abbreviate, defer or omit certain animal or clinical data requirements.

These provisions should not be treated as automatic exemptions. The applicability of any relaxation depends on the circumstances of the application and the determination of the Central Licensing Authority.

Class A Investigational Medical Devices

For an investigational medical device classified as Class A, clinical-investigation data may not be required unless the Central Licensing Authority considers such data necessary and records the reasons in writing.

Accordingly, applicants should assess the device's classification and intended use before determining the scope of the clinical evidence package.

Devices Incorporating Approved Drugs

Where a medical device incorporates a drug that has already been approved and marketed in India, Rule 63 provides for possible relaxation of certain additional studies where adequate published evidence regarding safety is available.

Depending on the circumstances, this may affect requirements relating to areas such as:

• Toxicology;
• Reproductive studies;
• Teratogenicity;
• Perinatal effects;
• Mutagenicity; and
• Carcinogenicity.

The availability of published evidence does not mean that these requirements are automatically waived. The regulatory authority determines the appropriate evidence requirements based on the specific application.

Use of Approvals From Certain Foreign Regulatory Authorities

An important provision under Rule 63 concerns medical devices that have already been approved by the relevant regulatory authority in certain specified countries.

The provision applies to devices approved in:

• United Kingdom;
• United States of America;
• Australia;
• Canada; or
• Japan.

Where the device has been marketed in the relevant country for at least two years, the Central Licensing Authority may consider whether clinical investigation results can be dispensed with, provided the prescribed conditions are satisfied.

The Central Licensing Authority must be satisfied with relevant safety, performance and pharmacovigilance information. In addition, there must be no evidence or theoretical possibility, based on existing knowledge, that the device could behave or perform differently in the Indian population.

The applicant must also provide a written undertaking to conduct post-marketing clinical investigation in accordance with a protocol approved by the Central Licensing Authority.

Therefore, an overseas regulatory approval should not be viewed as an automatic substitute for Indian regulatory assessment. It may, however, be relevant to determining the evidence package required for the Indian application.

CDSCO Decision Under Rule 63

After reviewing the application and supporting information, the Central Licensing Authority may grant permission in Form MD-27 or reject the application, with reasons recorded in writing.

The decision is ordinarily required within 120 days, subject to an extension of up to 30 additional days in accordance with the Rules.

If the application contains deficiencies or additional information is required, the applicant may receive a written communication identifying the deficiencies or requirements.

Applicants should respond carefully and within the prescribed timeframe. Failure to provide requested information within the applicable 90-day period can result in rejection where the conditions specified under the Rules are met.

Where permission is not received or an application is rejected, the Rules provide an appeal mechanism to the Central Government, which may dispose of the appeal within 60 days from the date of appeal.

Rule 64: Permission for New In Vitro Diagnostic Medical Devices

Rule 64 provides a separate regulatory pathway for a new in vitro diagnostic medical device.

The application is submitted in Form MD-28 to the Central Licensing Authority along with:

• The applicable fee prescribed under the Second Schedule; and
• The information and documents specified in Part IV of the Fourth Schedule.

Because IVDs require assessment of analytical and clinical performance, applicants should ensure that the technical documentation and performance evidence are aligned with the intended purpose and classification of the IVD.

Relaxation for New IVDs

Similar flexibility is available under Rule 64 in specified circumstances involving:

• Life-threatening or serious diseases or conditions;
• Conditions of special relevance to the Indian health scenario;
• National emergencies;
• Extreme urgency;
• Epidemics; or
• Situations where no diagnostic option or alternative is available in India.

The Central Licensing Authority may, where appropriate, abbreviate, defer or omit specified clinical performance data requirements.

Class A New IVDs

For a new IVD classified as Class A, clinical performance evaluation data may not be necessary unless the Central Licensing Authority considers such information necessary and records reasons in writing, taking into account the nature of the device.

Again, this should be treated as a regulatory discretion rather than a blanket exemption from evidence requirements.

CDSCO Decision Under Rule 64

If the Central Licensing Authority is satisfied with the submitted information, permission may be granted in Form MD-29.

The application may be granted or rejected within 90 days, subject to an extension of up to 30 additional days as provided under the Rules.

Where deficiencies or additional information are identified, the applicant must respond within the applicable timeframe. Failure to provide the required information within the prescribed period may result in rejection in accordance with the Rules.

Rule 65: Conditions Attached to Permission

Permissions granted under Form MD-27 or Form MD-29 are subject to conditions specified under Rule 65.

These conditions are important because obtaining permission is not the end of the regulatory process. The permission holder must continue to meet applicable post-market and regulatory obligations.

Key requirements include:

1. Compliance With Submitted Specifications

The medical device must conform to the specifications submitted with the application.

Any significant change to the device, its specifications, manufacturing arrangements, intended purpose or other regulated characteristics should therefore be assessed under the applicable change-control and CDSCO requirements before implementation.

2. Periodic Safety Update Reports

For the Form MD-27 permission holder, Periodic Safety Update Reports (PSURs) are required:

• Every six months for the first two years following market launch; and
• Annually for the following two years.

A robust post-market surveillance system should therefore be established before commercial launch.

3. Notification of Market Launch

The date on which the device is launched in the Indian market must be communicated to the Central Licensing Authority as required under Rule 65.

Maintaining accurate records of the actual market-launch date is therefore important for determining applicable post-market reporting timelines.

4. Reporting of Suspected Unexpected Serious Adverse Events

A suspected unexpected serious adverse event must be reported by the Form MD-27 permission holder within 15 days of becoming aware of the event, in accordance with the applicable requirements.

Manufacturers and permission holders should establish documented complaint handling, vigilance and escalation procedures to ensure that reportable events are identified and submitted within the required timeframe.

Form MD-27 and Form MD-29

The two permissions serve different regulatory pathways:

Form MD-27 identifies the relevant manufacturer, manufacturing site and medical device(s) authorised for import or manufacture for sale or distribution, subject to the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.

Why Regulatory Compliance Matters for Novel Medical Devices

Novel medical devices often require a carefully planned regulatory strategy because there may be no directly comparable predicate device against which the applicant can rely on an established regulatory pathway.

Common challenges can include:

• Determining the correct risk classification;
• Establishing whether a predicate device exists;
• Defining the appropriate clinical investigation strategy;
• Preparing technical documentation;
• Establishing safety and performance evidence;
• Assessing the relevance of overseas regulatory approvals;
• Addressing CDSCO deficiencies;
• Managing post-market surveillance requirements; and
• Maintaining consistency between the submitted dossier and the marketed device.

Incorrect classification or an incomplete technical and clinical dossier can lead to regulatory queries, deficiencies, delays or, where applicable requirements are not satisfied, rejection of the application.

Applicants should also check whether a subsequent amendment, exemption, notification or CDSCO classification decision affects the applicability of Chapter VIII to their particular device.

For example, Class A non-sterile and non-measuring medical devices are subject to a specific registration framework. CDSCO states that such devices are exempt from specified licensing requirements, while mandatory registration through the Medical Devices Online portal and applicable labelling and standards requirements continue to apply.

CDSCO's current 2025 risk-classification notice also states that the classification list for Class A non-sterile and non-measuring devices is dynamic and subject to revision.

How MDR Consultants Can Support CDSCO Medical Device Applications

For manufacturers, importers and technology companies planning to introduce novel medical devices in India, professional regulatory support can help structure the application and documentation process.

Regulatory Strategy

Assessment of the proposed device, intended purpose, risk classification, predicate-device status and potentially applicable CDSCO pathway.

Dossier Preparation and Review

Preparation and review of relevant application documentation, including Forms MD-26 and MD-28, together with supporting technical, clinical and regulatory information.

Scientific and Technical Documentation

Review of the information required under Part IV of the Fourth Schedule, with a focus on completeness, consistency and scientific justification.

Clinical Investigation Support

Regulatory support for clinical investigation planning and documentation where clinical investigation is required under the applicable CDSCO framework.

Foreign Regulatory Approval Assessment

Evaluation of relevant approvals and market experience from jurisdictions such as the United States, United Kingdom, Australia, Canada and Japan where these may be relevant to the regulatory strategy under Rule 63.

CDSCO Deficiency Management

Preparation and submission of responses to CDSCO queries and deficiencies within the applicable regulatory timelines.

Post-Approval Compliance

Support with applicable post-market obligations, including PSUR preparation and adverse-event reporting for relevant Form MD-27 permissions.

Regulatory Documentation

Development of accurate, consistent and audit-ready regulatory documentation aligned with the applicable MDR 2017 requirements.

Market-Entry Planning

A structured regulatory strategy can help reduce avoidable deficiencies and support a compliant pathway for introducing novel medical technology into the Indian market.

Conclusion

The Medical Devices Rules, 2017 provide a specific regulatory framework for medical devices without predicate devices and for new in vitro diagnostic medical devices.

Rule 63 addresses medical devices without a predicate device and provides the application pathway through Form MD-26, with permission granted through Form MD-27 where the applicable requirements are satisfied.

Rule 64 establishes the corresponding pathway for new IVDs through Form MD-28, with permission granted through Form MD-29.

Rule 65 sets out important conditions associated with these permissions, including conformity with submitted specifications and specified post-market safety obligations.

For manufacturers and importers, successful regulatory planning requires more than simply completing an application form. The applicant should first establish the device's classification, predicate status, intended use, clinical evidence requirements and applicable CDSCO pathway. The applicant should also consider subsequent amendments, exemptions and current CDSCO notifications that may affect the regulatory requirements for the particular device.

For the latest applicable requirements, applicants should verify the current Medical Devices Rules, CDSCO notifications, classification lists and regulatory guidance before submitting an application. CDSCO maintains the official MDR 2017 and Medical Device & Diagnostics resources on its website.

Last Updated : 21 Sep 2026