Navigating the regulatory landscape for medical devices in India, particularly under the Central Drug Standard Control Organization (CDSCO), can be intricate. Operon Strategist specializes in providing expert guidance and support to companies aiming to comply with the regulatory requirements for medical device registration in India.

Overview of CDSCO Medical Device Registration in India:

The CDSCO, operating under the Ministry of Health and Family Welfare, is the regulatory authority overseeing medical device registration in India. Unlike the earlier scenario where no approvals were needed, the current process involves adherence to CDSCO norms for manufacturers or firms setting up medical device manufacturing in India.

Operon Strategist offers comprehensive CDSCO medical device regulatory consulting services, ensuring companies meet the necessary standards.

CDSCO Medical Device Registration in India

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CDSCO MD Online Registration:

The MD online CDSCO registration platform streamlines the registration process for pharmaceutical products, medical devices, and cosmetics. It facilitates manufacturers, importers, and distributors in obtaining the required licenses and approvals for product sale and distribution in India, promoting efficiency and transparency.

What is Classification of Medical Devices as per CDSCO:

MDR 2017 has categorized the devices as Class A, Class B, Class C and Class D. Below table will spread some light on classification of medical devices.

 
 
 
 
 
 

Type 

 
 
 
 

Risk 

 
 
 
 

Example 

 
 
 
 

Class-A 

 
 

Low risk 

 
 

Bandage, examination loves etc. 

 
 
 
 

Class B 

 
 

Low-Medium Risk 

 
 

B.P. monitoring device, thermometer 

 
 
 
 

Class C 

 
 

Moderate to High Risk  

 
 

Implants, catheter 

 
 
 
 

Class D 

 
 

High Risk  

 
 

Heart Valve. 

Step-by-Step Process to Register Medical Devices:

Operon Strategist outlines the step-by-step process for CDSCO medical device registration:

    • Determine Classification: Identify the regulatory classification of the medical device based on risk.
    • Prepare Technical Documentation: Compile necessary technical documentation ensuring compliance with CDSCO requirements.
    • Appoint an Indian Authorized Agent: Select a local representative in India for regulatory purposes.
    • Submit Application to CDSCO: Prepare and submit the registration application with required documents.
    • Review and Approval: CDSCO reviews the application and may request additional information. Cooperate with the process.
    • Inspection and Quality Management: Certain high-risk devices undergo inspection. Ensure compliance with quality management standards.
    • Approval and Registration: Upon successful review, CDSCO issues a registration certificate.
    • Post-Market Surveillance: Ensure ongoing compliance with post-market requirements.

CDSCO Import License Registration for Medical Devices

For any medical device that is imported into India, it’s mandatory to have a CDSCO Medical Device Import License.CDSCO import license registration is mandatory for Class A and B and all notified Class C and D medical devices from 1st October 2022.

CDSCO import license will be mandatory for all non-notified Class C and D medical devices from 1st October 2023. The CDSCO voluntary registration of medical devices in India for all non-notified Class C and D medical devices will be valid up to 30 September 2023.

Many companies in India bring raw materials, semi-finished products, or components to India. In order to sell this finished medical device, the final assembly and final packaging of the medical device in India require a CDSCO manufacturing license. However, if you require a complete finished product outside India, you will require a CDSCO import license.

Operon Strategist's Role in CDSCO Medical Device Registration in India?

As a CDSCO registration consultant, Operon Strategist simplifies the complex registration process by providing expert regulatory assistance. Services include categorization evaluation, document preparation, timely filing of applications, and addressing CDSCO information requests. Operon Strategist ensures a smooth CDSCO registration process, supporting clients with regulatory expertise in importing and exporting medical devices.

For regulatory support for medical devices in India, contact Operon Strategist.