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The Central Drugs Standard Control Organization (CDSCO) is the governing body that oversees medical device registration in India. It functions under the Directorate General of Health Services within the Ministry of Health & Family Welfare.<br><br>Products Covered<br><br>As of October 1, 2023, all Class A (both measuring/sterile and non-measuring/sterile), Class B, Class C, and Class D medical devices require registration .
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Presentation by ELT CORPORATE Medical Device Registration Understanding Of Medical Device Registration WWW.MEDICALDEVICEREGISTRATION.COM
Medical Device Registration Introduction Overview of the this topic An overview of medical device registration involves understanding the comprehensive process by which medical devices gain approval, authorization, or certification to be legally marketed and sold in a specific region or country. This process ensures that medical devices meet predefined standards of safety, efficacy, and quality before they are introduced into the market for patient use.
Medical Device Registration Importance of MDR India has a robust regulatory framework for medical devices overseen by CDSCO. CDSCO enforces various regulations and guidelines, such as the Medical Device Rules, 2017, to ensure safety and quality standards are met. Compliance with these regulations is crucial for market entry and continued operation in India's medical device industry.
Medical Device Registration Types Of MDR License Manufacturing License Import License Market Authorization Or Apporval Product Registration Certificate Clinical Trial License Or Approval Special Use Authorization Quality Management System Certification Distributor or Wholesale License Medical
Presentation by ELT CORPORATE Medical Device Registraation Thank You Get In Touch With Us For Medical Device License In India +91 98919 98002 hello@medicaldeviceregistration.com Sector 3, Rohini, New Delhi - 110085 HTTPS://MEDICALDEVICEREGISTRATION.COM/CDSCO-REGISTRATION/