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.