Registration Support

ClinChoice leverages its team of regulatory strategists and in-country affiliates for first-time-right product registration and maintenance submissions to health authorities.

Complete Registration Support Services
- Preparation of regulatory documentation and submissions for product registrations and listings in country-specific formats
- Expertise preparing:
  - Pre-submission support documents
  - 510(k) premarket notifications
  - Investigational device exemption applications
  - Premarket approval applications (PMA)
  - 513(g) requests for classification
  - De Novo classification applications
- Submission of regulatory documentation and applications through health authority portals
- Assessment of design history file (DHF) and review of clinical, safety, and risk documents
- Support for registration of local and foreign establishments in new markets before product registration
- Comprehensive support for ISO 13485 certification to aid product registration in specific markets
- Authoring of standard operating procedures and detailed work instructions to accelerate the creation of regulatory documents and submissions for different countries
- Organization of documents for product registration in the QMS to reduce authoring time and shorter response time to health authority queries
- Support for creation of legal documents for import and export based on country-specific requirements
- Preparation of new or upgrading of existing clinical evaluation and technical documents