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.
     
Free Sale Certificate Issue NOC from CDSCO Test License on Form 29