We offers expert services for CDSCO online registration in Egypt. Our team provides comprehensive guidance on medical device registration, licensing, and compliance with India’s regulatory standards. Streamline your registration process with our experienced consultants.

An Overview Of CDSCO Registration

CDSCO registration is a mandatory process for medical device makers in India, governed by the Central Drugs Standard Control Organisation (CDSCO). It ensures adherence to safety and efficacy requirements. The registration process entails submitting an application, supporting documentation, and costs. The CDSCO reviews the provided information, conducts audits as needed, and issues a registration certificate once approved. This registration is required for marketing medical devices in India and is part of the regulatory compliance process to protect public health.

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The Role of CDSCO Certification

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring the safety, efficacy, and quality of medical devices in India. Obtaining a CDSCO certificate and CDSCO license is essential for manufacturers aiming to market their medical devices legally. This certification process not only validates the compliance of medical devices with regulatory standards but also enhances the credibility of the manufacturer.

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. 

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. 

Who Should Apply for Indian Import License for Medical Devices? 

Applicable when you wish to import medical devices from Egypt to India. However medical devices need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in India.   

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Application Process to Grant Indian Import License: 

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

  • Appointment of authorized agent (from Egyptian firm in India) having license for sale or distribute 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 on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15  

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, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations. Operon Strategist assists medical device distributors and medical device wholesalers in Egypt to procure CDSCO import license for medical devices.

How Can We Help You? 

Operon strategist is the leading medical device regulatory consulting company. We provide regulatory guidance to national as well as international manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.  

 Our Competencies: 

  • Cost effective services  
  • Strong relations with regulatory bodies. 
  • Experienced regulatory team 
  • We represent on behalf of our clients for Audits of FDA, ISO, & CE. 
  • Competent Technical staff. 

For free consultation Contact us now.

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. For free consultation Contact us now.