Licensing 

Our Experienced 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 Manufacturing License in Form 28
• Renewal of Manufacturing License
• Issue of WHO G.M.P Certificate.
• Issue of COPP.
• Issue of State Good Manufacturing Practices (GMP) Certificate
• Issue of Non-Conviction Certificate
• Issue of Performance Certificate
• Issue of Validity Certificate
• Issue of GLP Certificate
• Free Sale Certificate (FSC)
• Issue NOC from CDSCO
• Grant of Test License on Form 29
• Grant of License in Forms 20-B 21B 20-G 20-D

Licenses and Permissions as MDR (Medical Device Rule) 2017 effective on 01st January 2018

• Form MD-5       License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
• Form MD-6       Loan License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
• Form MD-9       License to Manufacture for Sale or for Distribution of Class C or Class D
• Form MD-10     Loan License to Manufacture for Sale or for Distribution of Class C or Class D 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

Strengths of DKNSB 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.