CDSCO Import License for Class C and D Devices

Overview

Based on current Data (2023), the CDSCO import license process for importing Class C & D Medical Devices has been comprehensively captured and is presented in this Article. The rationale for this comprehensive overview stems from the need to understand and respect the potential impact of these devices on patient safety and the communities they serve.

The Indian government implemented its first set of regulations for medical devices in 2017 by creating the Medical Devices Rules (MDR). However, in 2019, this legislation was incorporated into the Drug and Cosmetics Act (1940), resulting in the establishment of a robust regulatory framework based on risk assessment when making decisions concerning medical devices.

The importation of moderate-to-high risk (Class C) and high-risk (Class D) medical devices requires an import license from CDSCO before being shipped into India. As per the medical device definition, only Class C and D medical devices can harm patients or affect the community in a negative way. As a result, CDSCO's evaluation process for medical devices (Class C & D) is thorough and includes evaluation of the Device's Quality Management System, Safety of the Device, Performance of the Device, Support for the Device through Clinical Evidence and the manufacturer's Post-Market Obligation (for Class C and D devices).

What are Class C & D Medical Devices?

In India, medical devices are divided into four groups (A, B, C and D) based on the level of danger related to how the device will be used.

• Group C – Moderate to High Risk Devices

These types of devices have the potential to create serious threats to someone's wellbeing because they typically will either assist or prolong a person's life, and/or if they need long periods of invasive treatment.

Examples include the following:

Infusion pumps, Ventilators, Dialysis machines, Orthopaedic Implants, Anaesthesia workstations

• Group D – Highest Risk Devices

Devices that fall within this group carry the greatest possible threat, and if they fail, can cause serious injury or even death.

For example, cardiac pacemakers, heart valves, implantable defibrillators, coronary stents, and blood bags for transfusion all belong to Class C and D Equipment, which are considered to be life-supporting devices. Therefore, any Class C and D Equipment must be approved by the Central Drugs Standard Control Organization (CDSCO) before being brought into India, even if they were previously approved by other countries or regulatory agencies.

Who Needs a CDSCO Import License?

• To import Class C or D medical devices for sale or distribution in India, importing entities must obtain CDSCO's import license.

• Importing entities include either an Indian Importer acting as an agent for a foreign manufacturer or an Indian Authorised Agent representing a foreign manufacturer.

• All entities that act as an agent for a foreign manufacturer must hold a current wholesale drug License issued by CDSCO, and bear the responsibility of abiding by the respective regulations, completing post-marketing surveillance, taking action following recalls, and implementing appropriate vigilance procedures where necessary.

Fees for Class C & D Device Import License

The government fees listed under the Second Schedule of the MDR 2017 are as follows:

- Import License Fee:

?50,000 per manufacturing site

- Device Fee:

?1,000 per distinct medical device

- Additional Inspection or Testing Fee:

To be paid if CDSCO orders an inspection of the plant or a sample test.

All fees must be paid via the CDSCO web portal when submitting Form MD-14.

Forms Used for Importing Class C & D Devices

For new medical devices or devices without prior approval in India, CDSCO may require additional permissions before granting the import license.

CDSCO Import Approval Timelines

The complexity and level of documentation for class C devices determine the length of time for approval; the length of time is approximately 6-9 months for class C devices and 9-18 months for class D devices, but this length of time will increase if the class D device requires clinical investigation. For plant inspections or review by expert committees, there may also be additional time needed for approvals based on compliance with findings. Approval timelines are often extended due to deficiencies in documentation, Incorrect classification of devices, and a lack of clinical evidence on the efficacy of the devices.

Key Documents Required for Class C & D Import License

• Administrative Documents

• Covering letter

• Duly filled Form MD-14

• Government fee payment receipt

• Wholesale drug license of an Indian importer

• Power of Attorney from foreign manufacturer (notarised & apostilled)

• Manufacturing & Quality Documents

• ISO 13485 Quality Management System certificate

• Plant Master File (PMF)

• Site inspection reports (if available)

• Technical Documentation (Device Master File – DMF)

• Device description & intended use

• Design and manufacturing process

• Risk management file (ISO 14971)

• Biocompatibility studies (where applicable)

• Electrical safety & EMC reports (IEC 60601 series)

• Sterilisation validation (if applicable)

• Shelf-life and stability data

• Clinical & Performance Evidence

• Clinical evaluation report

• Clinical investigation data (mandatory for new Class C/D devices unless waived)

• Performance testing & bench studies

• Regulatory Documents

• Free Sale Certificate / Market Authorization from the country of origin

• CE Certificate / US FDA approval (if available)

• Declaration of Conformity

• Labeling & IFU

• Labels complying with MDR 2017

• Instructions for Use (IFU)

• Storage conditions & warnings

Step-by-Step Process for Class C & D Import License

Step 1: Device Classification: 

Confirm classification as Class C or Class D using MDR 2017 and the latest CDSCO classification list.

Step 2: Appointment of Indian Authorised Agent

An Indian entity with a valid wholesale license must be appointed by foreign manufacturers to be able to market their products in India.

Step 3: Preparation of Documentation

Prepare and compile the necessary documentation, including DMF, PMF, QMS certificates, clinical evidence and regulatory compliance documentation.

Step 4: Online Application Submission

Complete and submit Form MD-14, along with the appropriate fees, to the CDSCO SUGAM portal.

Step 5: CDSCO Review

The CDSCO will review your application to ensure that the device is safe, effective and meets the requirements of the MDR 2017.

Step 6: Queries / Expert Committee Review:

Your application may be subject to queries or reviews by an Expert Committee.

Step 7: Plant Inspection (if applicable)

If required, the CDSCO may inspect your foreign manufacturing plant.

Step 8: Grant of Import License

Once the CDSCO is satisfied with your application, you will receive Form MD-15, which will allow you to import and market the device in India.

Step 9: Ongoing Compliance Responsibilities

After you receive your import license, you must continue to comply with the MDR 2017 through post-market surveillance, materia-vigilance reporting, change management approval and product recall procedures, and license retention/renewals.

Conclusion

Medical Devices that fall under Class C and Class D categories need to follow strict guidelines imposed by the government of India regarding the Medical Device Rules (MDR) of 2017 and the regulatory framework set up by the Directorate General of Health Services (DGHS), which is continuously evolving. The application process is complicated, very document-heavy, and highly scrutinised due to the very high-risk nature of these types of medical devices. To best prepare for a successful application process in 2025, manufacturers/applicants must:

• Classify Medical Device Correctly

• Create detailed technical documentation and clinical documentation

• Maintain QMS (Quality Management System) in accordance with ISO 13485

• Reply to queries from DGHS promptly

• Create realistic timelines

• Well-planned regulatory strategies reduce delays and increase the likelihood of timely and efficient entry of critical medical devices into the Indian Healthcare Sector.

Author:

YOSHITA SHARMA
Indore, Madhya Pradesh
NMIMS, Indore BBA LL.B. (Hons.), Final Year