What is CDSCO Registration?

CDSCO registration is the mandatory approval process for medical devices that are imported into India. CDSCO stands for Central Drugs Standard Control Organization, the national regulatory authority under the Indian Ministry of Health.

CDSCO registration is required for:

  • Importing medical devices into India
  • Manufacturing regulated devices in India
  • Selling or distributing notified medical devices

Who Needs CDSCO Registration in Egypt?

Medical device manufacturers in Egypt planning to export to India must obtain CDSCO registration. This includes:

  • Class A, B, C, or D medical devices
  • IVD devices
  • Combination products

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What Are the Objectives of CDSCO Objectives?

  • Approval of new drugs and clinical trials. 
  • Import licensing. 
  • Manufacturing medical devices licensing. 
  • Licensing of blood banks, vaccines and some medical devices. 
  • Amendment to Drugs & Cosmetics Act and rules. 
CDSCO Registration

What is the 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. 

 

CDSCO Registration Process for Egyptian Manufacturers

  1. Check Device Classification under MDR 2017
  2. Appoint an Authorized Indian Agent
  3. Prepare Technical Documentation
  4. Submit Application to CDSCO
  5. Respond to Queries or Site Audits (if required)
  6. Obtain Registration Certificate (Form MD-15)

Documents Required for CDSCO Registration

  • Power of Attorney to Indian Agent
  • Device Master File (DMF)
  • Free Sale Certificate (FSC)
  • ISO 13485 / CE / FDA certificate
  • Clinical evaluation report
  • Undertaking and declarations

CDSCO Import License for Medical Devices from Egypt

To import medical devices into India from Egypt, a CDSCO import license is mandatory. This license is issued to the Indian Authorized Agent acting on behalf of the Egyptian manufacturer. The import license is issued in Form MD-15 as per MDR 2017.

Operon Strategist – CDSCO Consultant in Egypt

Operon Strategist is a trusted CDSCO consultant providing complete support for medical device registration in India. Services include:

  • Device classification and gap analysis
  • Technical file preparation
  • Appointing an Indian Authorized Agent
  • CDSCO form submissions
  • Handling queries and audits
  • Post-approval compliance

Benefits of CDSCO Registration Services by Operon Strategist

Operon Strategist provides fast and efficient CDSCO registration services that minimize documentation errors and improve the chances of regulatory approval. With a global presence and deep expertise in navigating India’s medical device regulations, Operon Strategist ensures smooth, end-to-end support for manufacturers expanding into the Indian market.

In addition to CDSCO registration, the following regulatory and technical services are available in Egypt:

This full-service approach helps manufacturers meet international standards while reducing regulatory risks and time to market.