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.
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
The purpose of medical device registration is to ensure that medical devices are safe and effective for their intended use and to provide assurance to healthcare providers and patients that the device meets specific standards for quality and performance.
The process of medical device registration can vary depending on the specific country or region, and may include pre-market clearance or approval, as well as ongoing post-market surveillance and reporting requirements.
