Medical Device Registration
Medical device registration is a time-consuming, complex process to obtain regulatory clearance or approval for a medical device and IVDs to be marketed and sold in a specific geographic region or country. Sponsors are expected to submit different types of applications with the supporting documentation for review and evaluation.
Medical device manufacturers must comply with the regulatory requirements of each country in which they seek to market their products, and must obtain the necessary approvals and certifications with the assistance of experienced regulatory and clinical affairs professionals.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
- Ensuring accuracy and completeness of information
- Drafting content as per latest regulatory guidelines
- Effectively communicating complex information
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
How We Can Help With Medical Device & IVDs Registrations
With our extensive MedTech industry experience, we assist medical device manufacturers to successfully complete product registrations across global regions. Following are the areas where we provide our expertise:
Device Classification
Complete medical device classification in the appropriate class based on its medical speciality or panel as mandated by each regulatory body (FDA, EMA, CDSCO-DCGI, TGA, PMDA, etc.)
Medical Device Import
Prepare and submit country specific applications, import licenses, device registrations, UDI information, CE Marking, packaging labels, and other regulatory documentation for obtaining medical device import authorization.
Establishment Registration & Device Listing
Complete declaration of confirmity, establishment registration, and electronic medical device registration on agency designated databases (FURLS, UDI, DCGI, etc.) and obtain the unique registration number.