Indian CDSCO Medical Device Registration

Innovative technology, a skilled and technically proficient workforce, and a robust regulatory framework are key drivers of growth in the Indian medical device industry. When an individual or organization plans to import medical devices into India, it is essential to understand the applicable regulatory requirements and compliance procedures.

As experienced CDSCO medical device regulatory consultants, we provide end-to-end support throughout the import approval process. Our team assists clients in navigating CDSCO regulations efficiently, ensuring compliance and a smooth pathway to market entry. Below is a brief overview of the CDSCO regulatory process.

CDSCO Registration Consultant in South Africa

Indian CDSCO Overview

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for cosmetics, pharmaceuticals, and medical devices. It is responsible for regulating the registration, import, manufacture, and sale of notified medical devices in India.

CDSCO functions under the Directorate General of Health Services (DGHS), which operates under the Ministry of Health and Family Welfare, Government of India, ensuring that medical products meet established safety, quality, and regulatory standards.

What are the Objectives of CDSCO?

The objectives of CDSCO (Central Drugs Standard Control Organization) regarding medical devices in India are to:

  1. Ensure the safety, efficacy, and quality of medical devices.
  2. Approve and regulate the import, manufacturing, and sale of medical devices.
  3. Set and enforce quality standards, including Good Manufacturing Practices (GMP).
  4. Monitor device safety through post-market surveillance.
  5. Regulate clinical investigations and trials.
  6. Control import and export of medical devices.
  7. Align with international standards for harmonization.
  8. Educate healthcare professionals and the public on device use.
  9. Collaborate with global regulatory agencies.
  10. Improve regulatory efficiency and timeliness.

Looking For CDSCO Registration Consultant in South Africa?

Classification of Medical Devices as per Indian 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. 

Medical Device Registration for Import

Medical devices entering India must comply with the Indian Medical Device Regulations established by the Central Drugs Standard Control Organization (CDSCO). CDSCO is responsible for the approval and regulation of medical devices, new drugs, and clinical trials in India. It also sets quality standards for drugs, oversees the quality of imported products, and coordinates regulatory activities with State Drug Control Organizations.

Operon Strategist supports medical device distributors and wholesalers across Africa in obtaining CDSCO import licenses for medical devices. Our team provides expert guidance throughout the licensing process, ensuring regulatory compliance and enabling smooth and timely access to the Indian medical device market.

Application Process to Grant Indian Import License:

An Import license is issued for the import of medical devices from South Africa to India. Both the foreign company and the Indian company jointly need to submit the documentation for the medical device and manufacturing unit. Process in brief:

  • Appointment of an authorized agent having the license for sale or distribution in India, eligible to make an application to grant import license.
  • Submission of the documents along with the application.
  • After examining the documents along with the application based on the inspection report, if the inspection has been done by the Central Licensing Authority and can be satisfied, grant the license in Form MD-15/26.

Operon Strategist's Role in CDSCO Registration?

The CDSCO registration process may look simple and easy but the reality is that one needs an expert regulatory consultant to complete this registration process.  As a CDSCO registration consultant, we make sure that the clients will get error-free results within the timeframe. Also, We provide regulatory assistance to our clients for importing and exporting medical devices from South Africa. We are an expert consultation firm for providing CDSCO (Indian Import License) regulatory services for India, Saudi Arabia, Costa Rica, the USA, the UK, Oman, Iran, Egypt, Germany, and the Netherlands.

FAQs

How to register medical devices in India?

Once the Indian Agent is appointed and the medical device classification is determined, an application must be submitted on the SUGAM portal, along with the required documents and fees, for CDSCO registration.

How is IEC different from a medical device import license?

IEC is a general trade license for import/export, issued by DGFT. A medical device import license, issued by CDSCO, ensures regulatory compliance for importing medical devices into India.

Does importing medical devices require a license from the Indian FDA?

Yes, under the Drugs and Cosmetics Act, medical devices need a registration certificate and import license from CDSCO. Approval is managed by DCGI, and importers may also need a state sales license.