OUR SERVICES what we do Contact Us for All Your Statutory and Regulatory Approvals MEDICAL DEVICE LICENSE & REGISTRATION Medical Device Manufacturing License: MD-5 MD-5 Granted for Medical Device Manufacturing of Class A or B Devices in India by State Licensing Authority Medical Device Import License MD-15 MD-15 is issued to allow the importers of Medical Devices to Import medical devices into India. Medical Device Loan License MD-6 & MD-10 MD-6 & MD-10 Granted for Medical Device Manufacturing on a loan Premises by State Licensing Authority & CDSCO Medical Device Test License MD-13 MD-13 Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation Medical Device Manufacturing License: MD-9 MD-9 Granted for Medical Device Manufacturing of Class C or D Devices in India by CDSCO Medical Device Wholesale License MD-42 MD-42 Registration Certificate is issued to Sell, Stock, Exhibit or Offer for Sale or Distribute Medical Device & IVD Free Sale Certificates Get the Free Sale Certificate of your Medical Devices for the Purpose of Export & Government Tender Purposes Registration for Class A Devices Get Registered your Class A Non-Measuring & Non-Sterile Devices with CDSCO PHARMACEUTICAL COMPLIANCE Drug Manufacturing License Form 25 & Form 28 is granted by the Drug Controller to Manufacture for Sale or Distribution of Drugs in India Loan License for Drug Manufacturing Form 25-A & Form 28-A are granted by the Drug Controller to Manufacture Drugs on a Loan Premises Food (FSSAI) License MD-6 & MD-10 Granted for Medical Device Manufacturing on a loan Premises by State Licensing Authority & CDSCO Cosmetic License Form 32 is granted by the Drug Controller to Manufacture for Sale or Distribution of Cosmetics in India AYUSH License License to Manufacture for Sale or Distribution of Ayurvedic/Unani/Siddha Products in India Import License Grant of License for import of drugs into India by Central Licensing Authority CDSCO ISO CERTIFICATION ISO 9001:2015 Comply with the requirement & Get ISO 9001:2015 Certified for your Quality Management System ISO 14001:2015 Comply with the requirement & Get ISO 14001:2015 Environmental management systems Certification ISO 13485:2016 Quality Management System Certification for Medical Device Manufacturers SA 8000:2014 Comply with the requirement & Get SA 8000 Social Accountability Certification US FDA COMPLIANCE Establishment Registration & Renewal Register Your Organization with US FDA to start exporting to US Market Medical Device Listing List your Medical Devices on US FDA Portal to to Start Export to US Market Product Registration & NDC Number Reserve NDC Number for your Products to Start Export to US Market Pre-Market Notification-510(K) Get Approved your Pre-Market Notification 510(k) of products intended to export to USA.