CDSCO Medical Device Registration India

Who Needs CDSCO Medical Device Registration?

Are You Planning to Market a Medical Device in India?

Medical devices placed on the Indian market are subject to applicable requirements under the Medical Devices Rules, 2017. The regulatory pathway depends on factors such as the device type, intended purpose, risk classification, and whether the product is manufactured in India or imported.

Medsure Can Support:

• Medical device manufacturers entering the Indian market

• International manufacturers planning to import devices into India

• Indian medical device manufacturers

• New medical device launches

• Manufacturers requiring device classification assessment

• Companies preparing CDSCO registration or licensing documentation

• Manufacturers reviewing existing regulatory documentation

• Companies responding to CDSCO regulatory queries or documentation requirements

Our CDSCO Registration Services

Regulatory Support Built Around Your Device

01 — Device Classification & Regulatory Assessment

We assess the device, intended purpose, and applicable classification requirements to help establish the appropriate regulatory pathway.

02 — Regulatory Pathway Strategy

We help determine the applicable CDSCO approval or licensing route based on the device and the manufacturer's regulatory activity.

03 — Technical Documentation

Support for preparing and organizing the technical and supporting documentation required for the applicable application.

04 — CDSCO Application Preparation

We help compile the required information and documentation into a structured regulatory application.

05 — Submission & Regulatory Review Support

Support throughout the submission and review process, including responses to regulatory questions and requests for clarification.

06 — Manufacturing & Import Regulatory Support

Support for applicable CDSCO regulatory requirements relating to manufacturing or importing medical devices in India.

CDSCO Registration Process

From Device Assessment to Regulatory Readiness

01 — Device Assessment

Review the device, intended use, manufacturer information, product characteristics, and target market activity.

02 — Device Classification

Determine the applicable risk classification and regulatory requirements for the device.

CDSCO's current online system provides provisions for medical-device risk-classification applications, reflecting the continuing development of India's regulatory framework.

05 — Application Submission

Compile and submit the application through the applicable CDSCO online system with the required supporting information.

07 — Approval / Licence

Support the process through issuance of the applicable regulatory approval or licence, where requirements are successfully met.

04 — Documentation Preparation

Prepare and organize the applicable technical and regulatory documentation.

06 — Regulatory Review

Support the manufacturer during CDSCO review and help address applicable questions, deficiencies, or requests for additional information.

03 — Regulatory Pathway

Identify the applicable licensing or approval pathway based on the device, classification, and whether the activity involves manufacturing or importing.

08 — Ongoing Compliance

Help maintain relevant documentation and address applicable post-approval regulatory requirements.

Frequently asked questions

What is CDSCO?

CDSCO, the Central Drugs Standard Control Organisation, is India's national regulatory authority for medical devices and other regulated products under its jurisdiction. Its medical-device online system provides facilities for applications and related regulatory activities.

Is CDSCO approval required for medical devices in India?

The applicable regulatory approval depends on whether the product falls within the regulated medical-device framework and on its specific classification and regulatory pathway. Regulated devices must meet the applicable requirements before they can be legally marketed through the relevant route.

How do I know which CDSCO pathway applies to my device?

The pathway depends on factors including the device's intended use, classification, product characteristics, and whether the activity involves manufacturing or importing. Medsure can assess these factors and help identify the applicable route.

What documents are required for CDSCO registration?

Requirements vary by device and application. Depending on the pathway, documentation may include technical information, device specifications, risk management, verification and validation evidence, labelling, IFU, manufacturing information, and applicable quality-system documentation.

Does CDSCO registration apply to imported medical devices?

Imported medical devices can be subject to applicable CDSCO regulatory and import-licensing requirements. The exact requirements depend on the device, classification, manufacturer, and applicable regulatory pathway.

Does every medical device require clinical investigation?

No. Clinical investigation requirements depend on the device and available evidence. Whether additional clinical evidence is necessary must be assessed based on the applicable regulatory requirements and characteristics of the device.

Can Medsure help with an existing CDSCO application?

Yes. Medsure can review existing documentation, identify potential gaps, support application preparation, and assist with regulatory responses where applicable.

Ready to Enter the Indian Medical Device Market?

Medsure Consulting helps medical device manufacturers navigate classification, documentation, application preparation, submission, and regulatory review for CDSCO requirements in India.