BEST CONSULTANT FOR MEDICAL DEVICES AND PHARMACEUTICAL REGULATORY, CDSCO, ISO, CE, ISI, USFDA, MDSAP, 510k, TGA AUSTRALIA & QUALITY MANAGEMENT SYSTEM CERTIFICATION

  • veteran.ecrep@gmail.com

Medical Devices and Drug Licensing

Online CDSCO Manufacturing and Import Licence & Certificate through Sugam Portal

CDSCO Licensing

Our Veteran Professionals are familiar with all aspects of Medical Device Regulatory Compliance in India. Our services include Obtaining Various Licenses and Certifications for Medical Devices- 

 

Grant of Mfg. Lic in Form MD-5 : License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
Grant of Mfg. Lic in Form MD-6 :Loan License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
Grant of Mfg. Lic in Form MD-9 : License to Manufacture for Sale or for Distribution of Class C or Class D
Grant of Mfg. Lic in Form MD-10 : Loan License to Manufacture for Sale or for Distribution of Class C or Class D Medical Device
Grant of Test License in Form MD-13
Grant of Import Lic in Form MD-15: Lic to Import of Medical Device
Form MD-23: Permission to Conduct Clinical Investigation
Form MD-25 : Permission to Conduct Clinical Performance Evaluation of New in Vitro Diagnostic Medical Device.
Form MD-27: Permission to Import or Manufacture for Sale or for Distribution of Medical Device which does not have predicate Medical Device
Form MD-29 : Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
Form MD-31: Certificate of Test or Evaluation by The Central Medical Device Testing Laboratory
Renewal of Manufacturing License
Issue of Market Standing, Non-convection certificate
Issue of Validity Certificate
Free Sale Certificate (FSC)
Issue NOC from CDSCO

Strengths of Veteran Licensing Services:

Providing guidance to develop your manufacturing premises as per regulatory requirements
Preparation of complete documents as per the requirements for all the mentioned licensing activities
Preparation and submission of application to CDSCO, Zonal and State Drug Controlling Authorities
Providing complete support for preparation to face inspection and audit