Our Experienced and Enthusiastic Team of Professionals can support your organization to get Manufacturing License for your Devices from CDSCO and State Licensing Authorities in an efficient and Reasonably Shortest Possible Time and Cost-effective Manner. Below are few services provided by us:
Guidance in development of Manufacturing Premises as per Regulatory Requirements
CDSCO, Zonal and State Drug Controlling Activities application preparation and submission
Documents preparation support as per Regulatory Requirements
Support for preparation of audit and inspection by CDSCO in case of Class C and Class D Medical Devices
Support for preparation of audit and inspection by State Licensing Authorities and CDSCO Approved Notified Bodies in case of Class A and Class B Medical Devices
Our services include Obtaining Various Licenses and Certifications for Medical Devices:
Manufacturing License in Form MD-5 for Class A and Class B Medical Devices.
Manufacturing License in Form MD-9 for Class C and Class D Medical Devices.
Loan License on Form MD-6 for Class A and Class B Medical Devices
Loan License on Form MD-10 for Class C and Class D Medical Devices
Loan License for Sterilization (ETO and Gamma Sterilization)
Test License on Form MD-12
License in Forms 20-B 21-B
Renewal of Manufacturing License
Issue of Non-Conviction Certificate
Issue of Performance Certificate
Free Sale Certificate (FSC)
Any Other License / NOC from CDSCO and State Licensing Authorities for Medical Devices
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DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.