MEDICAL DEVICE REGISTRATION
Product registration and continued maintenance in multiple countries can be very challenging. Each country has its own regulatory authority reinforcing compliance to its own regulatory requirements and quality standards. Moreover, some countries require all registration documents translated into their native language before submission such as China, Korea, Japan, Brazil and Mexico.
Global Regulatory Partners (GRP) Regulatory Affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of medical devices and IVDs in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities.
Through many years of operation, the GRP Regulatory Affairs team has established close working relationships with health authorities in many countries. GRP has developed regulatory and technical skills to assist medical device and IVD companies register their products efficiently anywhere in the world.
The GRP RA team has expertise in preparing the following applications:
- Investigational Device Exemption (IDE) preparation and submission
- Premarket Approval application (PMA) preparation and submission
- Premarket notification 510(K) preparation and submission
- CE Marking
- Technical Dossier preparation and submission
- STED dossier preparation and submission-
- License renewal (for international markets only)
- PMA supplements preparation and submission
- Amendments preparation and submission
Companies interested in introducing their medical devices or expanding their business into the United States of America, Latin America, Europe and Asia can contact us for guidance on developing successful regulatory strategies specifically for them.