RX-MEDICAL GLOBAl
A PROUD DIVISION OF HEALTHREG SOLUTIONS GROUPFINALLY A CONSULTANCY FOR MEDICAL DEVICE AND PRESCRIPTION REGISTRATION GLOBALLY
ABOUT US
Established in 2021 as part of HealthREG Solutions Group - RX-Medical Global has helped both start up and multinational companies get medical devices and prescriptions to markets in Australia and internationally. RX-Medical Global provides consulting services in the areas of medical device regulation and prescription including quality systems, clinical trials, TGA product registrations, FDA submissions, CE marking, EU MD Registrations. Supporting all of our clients with the end to end process.
OUR MEDICAL DEVICE SERVICES
Classification Registration of Class 1 , 2 , 510(k) , Class 3
Conformity assessments
Dossier Preparation
QMS and QMR Reviews
Risk Analysis Procedures
Labelling Compliance Assessment
Post-Market Surveillance & Vigilance
Advertising and Marketing Compliance Assessment
CE Marking
OUR PRESCRIPTION REGISTRATION SERVICES
Classification + Registration of Generic , OTC , and Prescriptions
CTD Module Preparation
Dossier Review Analysis
Pre Submission Meetings and Liaison
GMP Clearance and Licensing
Post-Market Surveillance & Vigilance
Advertising and Marketing Compliance Assessment
Pharmacovigilance
Contact us
Contact our following branches with your product enquires using our contact forms - our team will come back to you within 24 hours.
RX-DEVICES AND MEDICAL AUSTRALIA
RX -DEVICES AD MEDICAL EUROPE
RX- DEVICE AND MEDICAL AMERICAS
devices@rxmedicalglobal.com