Indian CDSCO Medical Device Registration

Innovative technology, proficient and technically expert people, finest regulatory framework are the contributing factors to the growth of the Indian medical device industry. When a person/firm wants to import devices from another country, they should understand the norms and regulatory procedures of that specific country. As a CDSCO medical device regulatory consultant, we provide full assistance in the process. Let’s understand the CDSCO regulatory process in brief.

CDSCO Registration Consultant in South Africa

Indian CDSCO Overview

The Central Drugs Standard Control Organization (CDSCO) is India’s national cosmetics, pharmaceutical, and medical device regulatory authority.

The CDSCO is responsible for regulating the registration & sale of notified medical devices in India. CDSCO is controlled and governed by the Directorate General of Health Services which comes under the Ministry of Health and Family Welfare Government of India.

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 be in compliance with the Indian medical device regulation set forth by the CDSCO for Registration. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, controlling the quality of imported drugs, and coordinating the activity of State Drug Control Organizations. Operon Strategist assists medical device distributors and medical device wholesalers in the South-Africa to procure CDSCO import licenses for medical devices.

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.