DEVICE IS NOT AVAILABLE IN INDIA (MD-27)

Central Licensing Authority (CLA): The Central Drugs Standard Control Organization (CDSCO) is responsible for granting this licence.

Application Portal

The application for the Grant of Permission to Import/Manufacture a Medical Device Without a Predicate Device (Form MD-27) is submitted through the SUGAM Portal, the online regulatory platform managed by CDSCO.

The form required for Grant of permission to import/Manufacture for sale or distribution of Medical Device which does not have Predicate Device:

Applicant Type	Application	License
Manufacturer/ Importer	Form MD-26	Form MD-27

Fee Structure:

Subject	Fee (in rupees) INR
Permission to import or manufacture a medical device which does not have its predicate device.	50000

Application Process:

Step-by-Step Application Process

1. Device Classification & Risk Assessment

Before submitting the application, classify the medical device as per the risk classification system under First Schedule, Part I of the Medical Device Rules, 2017:

• Class A (Low risk)

• Class B (Low to moderate risk)

• Class C (Moderate to high risk)

• Class D (High risk)

For a non-predicate device, CDSCO typically places it under Class C or Class D, requiring stringent evaluation.

2. Compilation of Technical Documentation

Since the device has no predicate, the following comprehensive documentation must be submitted to justify its safety, efficacy, and intended use:

(a) Device Master File (DMF)

(b) Clinical Evaluation Report (CER)

(d) Clinical Investigation Plan and etc.,

3. Submission of Form MD-26 to CDSCO

Once the documentation is ready, the applicant must submit Form MD-26 along with:

• Cover letter

• Application fee, along with Technical Documentation

The application can be submitted via the SUGAM online portal of CDSCO.

4. Evaluation by CDSCO

Upon submission, the Subject Expert Committee (SEC) and CDSCO will review the application for:

• Completeness of documentation

• Justification of device classification

• Adequacy of clinical evaluation data and etc.,

5. Clinical Investigation

If CDSCO mandates a clinical investigation, the applicant must:

(a) Apply for Clinical Trial Approval

• Submit Form MD-22 along with:

o Clinical trial protocol

o Investigator details

o Ethics Committee approval

o Patient safety and consent forms

(b) Conduct the Clinical Investigation

• Trials must comply with Good Clinical Practice (GCP) guidelines and Indian regulations.

• Data should establish the safety, performance, and risk-benefit ratio.

• Post-trial, the applicant submits the final clinical investigation report to CDSCO for review.

6. Grant of Permission (Form MD-27)

Once CDSCO is satisfied with the data, they issue Form MD-27, granting permission to:

• Manufacture or

• Import the medical device for sale or distribution.

This permission remains valid indefinitely, unless:

• The product is deemed unsafe.

• Manufacturing or import conditions change.

Key Considerations

• Regulatory Strategy: If similar devices exist in global markets, leveraging international approvals (e.g., US FDA, EU MDR) can help support the application.

• Timelines: The approval process can take 6–12 months depending on whether clinical investigations are required.